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For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":70402743,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":105127354,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":9118877,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":99029723,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":1601142,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":5909894,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":138685958,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"I","term_addition_version":8,"term_last_modified_version":15} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":89047615,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":8} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":35814258,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":8} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":78272485,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":96161760,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":55429293,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"I","term_addition_version":8,"term_last_modified_version":15} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":85653708,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":126921851,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":123484338,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":14008360,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":35252801,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":125818285,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":54691634,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":33963444,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"I","term_addition_version":8,"term_last_modified_version":15} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":72044265,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":112845690,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":8} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":61673739,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":8} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":135940093,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":96232953,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":378747,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":87818901,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":14970390,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":36004591,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":19635495,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":130942741,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"I","term_addition_version":8,"term_last_modified_version":15} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":54767913,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":44800870,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":5903253,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":118947198,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":32965901,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"I","term_addition_version":15,"term_last_modified_version":25} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":133424831,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":5242590,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":28446349,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":20272559,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":114604001,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":35934300,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":24} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":83516491,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":15.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":96135475,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":19741470,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":60970037,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":25018298,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":81374388,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":30205883,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":17.1,"term_last_modified_version":17.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":146028736,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":15,"term_last_modified_version":15} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":76526832,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":52102341,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":25284883,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":8} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":49194893,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":8919281,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":8.1,"term_last_modified_version":14.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":85697443,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":121433552,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":83726598,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":103361996,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":10.1,"term_last_modified_version":12.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":67919987,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":11.1,"term_last_modified_version":11.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":34028890,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":14,"term_last_modified_version":14} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":48943787,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":14,"term_last_modified_version":14} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":119256966,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":15.1,"term_last_modified_version":15.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":38941234,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":17.1,"term_last_modified_version":17.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":101814335,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":18,"term_last_modified_version":18} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":145843808,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":19.1,"term_last_modified_version":19.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":4623395,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":20,"term_last_modified_version":21} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":79359008,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":21,"term_last_modified_version":21} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":117113010,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"I","term_addition_version":25,"term_last_modified_version":25} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":61506085,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24,"term_last_modified_version":24} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":86171962,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24.1,"term_last_modified_version":24.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":45120110,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24.1,"term_last_modified_version":24.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":144599441,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24.1,"term_last_modified_version":24.1} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":63906336,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"I","term_addition_version":25,"term_last_modified_version":25} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":56061064,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":25,"term_last_modified_version":25} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":82786575,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"I","term_addition_version":25,"term_last_modified_version":25} {"smq_code":50207975,"smq_name":"Hepatitis, non-infectious (SMQ)","smq_level":4,"smq_description":"This SMQ is a sub-SMQ of Drug related hepatic disorders - severe events only (SMQ), which is itself a sub-SMQ of Drug related hepatic disorders - comprehensive search (SMQ). For detailed description, please refer to the one in Hepatic disorder (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":38917731,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"I","term_addition_version":25,"term_last_modified_version":25} {"smq_code":32885138,"smq_name":"Ischaemic heart disease (SMQ)","smq_level":1,"smq_description":"Myocardial ischemia refers to lack of oxygen due to inadequate perfusion of the myocardium; causes an imbalance between oxygen supply and demand - Most common cause of myocardial ischemia is obstructive atherosclerotic disease of epicardial coronary arteries","smq_source":"Harrison's Textbook of Internal Medicine","smq_note":"NOTE: Original version of the broad searches included PT Aspartate aminotransferase abnormal and PT Aspartate aminotransferase increased. These terms were removed based on test results (retrieved a large number of irrelevant cases). If examining older data (i.e., prior to year 2000), one might consider including these terms in the query. Unlike Myocardial infarction (SMQ), Other ischaemic heart disease (SMQ) is not a standalone SMQ topic. It should only be used as part of its superordinate SMQ topic - Ischaemic heart disease (SMQ).","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":70272710,"term_level":0,"term_scope":0,"term_category":"S","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":32885138,"smq_name":"Ischaemic heart disease (SMQ)","smq_level":1,"smq_description":"Myocardial ischemia refers to lack of oxygen due to inadequate perfusion of the myocardium; causes an imbalance between oxygen supply and demand - Most common cause of myocardial ischemia is obstructive atherosclerotic disease of epicardial coronary arteries","smq_source":"Harrison's Textbook of Internal Medicine","smq_note":"NOTE: Original version of the broad searches included PT Aspartate aminotransferase abnormal and PT Aspartate aminotransferase increased. These terms were removed based on test results (retrieved a large number of irrelevant cases). If examining older data (i.e., prior to year 2000), one might consider including these terms in the query. Unlike Myocardial infarction (SMQ), Other ischaemic heart disease (SMQ) is not a standalone SMQ topic. It should only be used as part of its superordinate SMQ topic - Ischaemic heart disease (SMQ).","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":146302418,"term_level":0,"term_scope":0,"term_category":"S","term_weight":0,"term_status":"A","term_addition_version":12,"term_last_modified_version":12} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":17258462,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":19471945,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":43921004,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":17799305,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":104104705,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":45779826,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":114697328,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":35780209,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":10} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":70775659,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":38107233,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":3992609,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":80796460,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":98601069,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":115114983,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":126054014,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":81112176,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":72433280,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":26223529,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":1434370,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":121342228,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":11502122,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":121211075,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":136652229,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":34031121,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":73624309,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":83540893,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":1102837,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":16670031,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":116670926,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":134586089,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":137444644,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":108768377,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":104422427,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":89030054,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":41115191,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":65393199,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":138347687,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":46685056,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":116020169,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":117586379,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":147590309,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":116602597,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":92132944,"term_level":4,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":87027091,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":21364113,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":77937587,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":98693412,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":83026753,"term_level":4,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":40584893,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":134016869,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":7881078,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":41748056,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":98453153,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":23123723,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":68295289,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":40776457,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":35499706,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":48250341,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":140853845,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":116673561,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":86634698,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":84717427,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":65569180,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":110625714,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":14160135,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":130487241,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":94539101,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":19202891,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":145343485,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":82888502,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":19335564,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":120206058,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":49377829,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":125941643,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":66579331,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":101940060,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":122518053,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":65908070,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":102217815,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":38092155,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":139777049,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":113716839,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":34185065,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":36162835,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":28875012,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":86436805,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":116525930,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":53466569,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":85587287,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":83190354,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":23305207,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":83626609,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":46690917,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":146854016,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":87010571,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":39255781,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":10206069,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":65299332,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":142200976,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":90972688,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":41001211,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":95280398,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":46019775,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":121624142,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":51653872,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":134871104,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":46653837,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":8679282,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":107997667,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":67775207,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":98730674,"term_level":4,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":137967142,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":3641159,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":132060856,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":84327110,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":42228388,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":43588195,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":91059332,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":2208437,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":103866807,"term_level":4,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":143913071,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":129275898,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":58804174,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":144180043,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":86433949,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":77391436,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":81599960,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":10082881,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":131268054,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":129989691,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":43993483,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":92000307,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":38161232,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":144899706,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":63115222,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":65597299,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":49504223,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":2444178,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":64580624,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":125099317,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":114782586,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"I","term_addition_version":9,"term_last_modified_version":18.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":65482573,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":110606114,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":97374563,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":58358373,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":38749814,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":61483542,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":62792141,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":98487828,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":76709840,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":11500253,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":100774775,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":129443992,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":11957448,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":79336504,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":90142182,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":25888731,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":35629461,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":53025091,"term_level":4,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":112182115,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":132852264,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":95702061,"term_level":4,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":121158786,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":47760037,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":75656026,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":6849807,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":1511835,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":109168659,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":4888784,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":22080759,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":135688269,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":12446767,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":111247376,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":69529758,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"I","term_addition_version":10,"term_last_modified_version":12} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":128588626,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":35624372,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":75724406,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":3264193,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":107182810,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":13766658,"term_level":4,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":136973502,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":54687744,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":39038651,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":29875711,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":6103977,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":135513441,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":136475521,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":38566517,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":30581925,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":69113147,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":13279025,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":95716971,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"I","term_addition_version":9,"term_last_modified_version":18.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":43242286,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":117285587,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":127893888,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":35112315,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":70591975,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":41075812,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":40225202,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":105560111,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":121543453,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":66259583,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":76997223,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":69205934,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":134255939,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":90729629,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":111643547,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":133234034,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":10383562,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":48606272,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":96817518,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":81422028,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":104324948,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":23769644,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":146224873,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":48857465,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":66498649,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":75073063,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":106085930,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":91230030,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":32302609,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":132683488,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":77137538,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":33936246,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"I","term_addition_version":9,"term_last_modified_version":14.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":136003875,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"I","term_addition_version":9,"term_last_modified_version":14.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":69130250,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"I","term_addition_version":9,"term_last_modified_version":14.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":77358024,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"I","term_addition_version":9,"term_last_modified_version":14.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":130151164,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"I","term_addition_version":9,"term_last_modified_version":14.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":149678488,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"I","term_addition_version":9,"term_last_modified_version":14.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":121650449,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":130052013,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":126208262,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":70721982,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":13.1,"term_last_modified_version":13.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":74621581,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":79821543,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":77892715,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":17771444,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":130799844,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":29365513,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":109779004,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":87270744,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":46877661,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":1210895,"term_level":4,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":13568956,"term_level":4,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":56280861,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":22817446,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":121026016,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":111801513,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":107937906,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":90547499,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":6385764,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":119979912,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":9014962,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":129239778,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":18378961,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":131547340,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":31863665,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":148665423,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":9023868,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":79213259,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":4218295,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":104721331,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":6480865,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":44560710,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":42210762,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":126229216,"term_level":4,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":10.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":2029011,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":97650619,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":47651828,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":137390681,"term_level":4,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":16845028,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":123506342,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"I","term_addition_version":9,"term_last_modified_version":15} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":3828493,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":14844400,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":5834234,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":95689970,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":80205356,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":10959965,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":145338564,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"I","term_addition_version":9,"term_last_modified_version":18.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":93472335,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":104858899,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":21615966,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":85617094,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":120167203,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":78327937,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":111319965,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":148268610,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":72987990,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":52448343,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":119860978,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":115730081,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":81605648,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":3516427,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":49420079,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":47976292,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":10729985,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":131777900,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":46020777,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":22629481,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":72419370,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":31386464,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":285317,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":81244679,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":106930778,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":669655,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":18431800,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":45498071,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":46595665,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"I","term_addition_version":9,"term_last_modified_version":11.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":137416900,"term_level":4,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"I","term_addition_version":9,"term_last_modified_version":11.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":37179617,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":117965036,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":81697731,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":129808551,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":37822982,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":89488718,"term_level":4,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":32491745,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":62690438,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":98526829,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":32240622,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":89684340,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":89863693,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":137068183,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":115166779,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":129889005,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":140457158,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":20651844,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":56342478,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":77918926,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":81772705,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"I","term_addition_version":10,"term_last_modified_version":12} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":50272873,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":20630188,"term_level":4,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":142457543,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":145685783,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":27042526,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":109187497,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":21952212,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":57277715,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":144892344,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":88842059,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":110748559,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":17733689,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":40627492,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":34093060,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":119592946,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":41316109,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":10052570,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":39827533,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":43453561,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":82311896,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":4711866,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":13.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":61336396,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":121456732,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":26761280,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":47873104,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":20541477,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":29774833,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":41345404,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":149226503,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":59542105,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":19.1,"term_last_modified_version":19.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":79979073,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":107993427,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":57387297,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":90464990,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":143976046,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":125156667,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":21684929,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":25877984,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"I","term_addition_version":9,"term_last_modified_version":18.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":68638934,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":40902203,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":147539026,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":35712712,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":119878274,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":50804892,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":37611702,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":33959268,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":102991397,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":88292987,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":98980232,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":2768103,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":66221743,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":89439098,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":77088952,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":8426392,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":69911241,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":13.1,"term_last_modified_version":13.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":113065013,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":13.1,"term_last_modified_version":13.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":128642303,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":9324762,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":114314176,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":112187765,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":69871591,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":2354333,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":149108029,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":16837850,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":35006136,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":132348224,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":104913319,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":115879206,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":43505480,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":39765515,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":143965168,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":46871913,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":57137654,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":13980446,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":79970617,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":87471078,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":100844511,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":131489395,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":135648258,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":114323419,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":34119344,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":120076296,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":85491218,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":28171689,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":65494135,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":36261198,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":74586961,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":118948148,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":64083962,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":128664564,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":116209003,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":2623577,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":26193469,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":93585618,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"I","term_addition_version":10,"term_last_modified_version":12} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":2809741,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":70942904,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":59797468,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":50058811,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":15770474,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":110653264,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":28069996,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":50623793,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":53915829,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":38110539,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":137305401,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":131452826,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":42025540,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":42498198,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":106591552,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":15211864,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":67255648,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":4207619,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":126630764,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":18544131,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"I","term_addition_version":9,"term_last_modified_version":22} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":81099919,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":95808962,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":149090194,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":124775008,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":55641413,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":136317292,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":113365243,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":29976332,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":116249534,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":26242312,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":105806691,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":47687116,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":47339757,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":88748817,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":137698165,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":50871501,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":34814757,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":149327451,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":98603204,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":117682195,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":145138611,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":52030765,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":71455249,"term_level":4,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":95121218,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":141896664,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":10.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":97146564,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":42641809,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":75327985,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":33181184,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":90210360,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":15957866,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":56960031,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":14,"term_last_modified_version":14} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":13424936,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":120197304,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":28772127,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":18609044,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":137416305,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":23690033,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":94018215,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":1833249,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":44171754,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":15048907,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":75889850,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":51965182,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":147419525,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":2683192,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":54208765,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":48389160,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":53088262,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":45762493,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":75769696,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":147694977,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":99141745,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":130352848,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":132435991,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":10,"term_last_modified_version":10} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":136401130,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":10,"term_last_modified_version":10} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":50593631,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":10,"term_last_modified_version":10} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":2553258,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":10,"term_last_modified_version":10} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":113996039,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"I","term_addition_version":10,"term_last_modified_version":12} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":97168286,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":11,"term_last_modified_version":11} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":89537418,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":11,"term_last_modified_version":11} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":96935923,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":14.1,"term_last_modified_version":14.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":74790861,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":14.1,"term_last_modified_version":14.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":77144713,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":14.1,"term_last_modified_version":14.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":147111946,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":14.1,"term_last_modified_version":14.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":35928982,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":14.1,"term_last_modified_version":14.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":1857992,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":14.1,"term_last_modified_version":14.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":2285568,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":16,"term_last_modified_version":16} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":7796017,"term_level":4,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":16,"term_last_modified_version":16.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":66996405,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":16.1,"term_last_modified_version":16.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":105564259,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":16.1,"term_last_modified_version":16.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":71161821,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":17,"term_last_modified_version":17} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":135839489,"term_level":4,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":17,"term_last_modified_version":17} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":104086928,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":17,"term_last_modified_version":17} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":136866749,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":18,"term_last_modified_version":18} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":3650156,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":18,"term_last_modified_version":18} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":139557258,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":18.1,"term_last_modified_version":18.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":76511019,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":18.1,"term_last_modified_version":18.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":129794693,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":19,"term_last_modified_version":19} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":45790198,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":19,"term_last_modified_version":19} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":145470557,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":19,"term_last_modified_version":19} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":145713570,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":19,"term_last_modified_version":19} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":60663046,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":19.1,"term_last_modified_version":19.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":127909775,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":20,"term_last_modified_version":20} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":34067723,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":20.1,"term_last_modified_version":20.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":89797137,"term_level":4,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":20.1,"term_last_modified_version":20.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":6144432,"term_level":4,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":21,"term_last_modified_version":21} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":43304172,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":21.1,"term_last_modified_version":21.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":50349529,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":21.1,"term_last_modified_version":21.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":103339827,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":21.1,"term_last_modified_version":21.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":119432626,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":22,"term_last_modified_version":22} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":43290179,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":22,"term_last_modified_version":22} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":109671736,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":22,"term_last_modified_version":22} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":91692147,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":22,"term_last_modified_version":22} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":4612058,"term_level":5,"term_scope":1,"term_category":"B","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":61450729,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":24,"term_last_modified_version":24} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":102091458,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":24.1,"term_last_modified_version":24.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":27093429,"term_level":4,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":25.1,"term_last_modified_version":25.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":10409869,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":25.1,"term_last_modified_version":25.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":32198134,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":46653857,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":65728951,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":137805324,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":143727940,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":26.1,"term_last_modified_version":26.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":104574930,"term_level":5,"term_scope":1,"term_category":"C","term_weight":0,"term_status":"A","term_addition_version":26.1,"term_last_modified_version":26.1} {"smq_code":59056246,"smq_name":"Neuroleptic malignant syndrome (SMQ)","smq_level":1,"smq_description":"Neuroleptic malignant syndrome (NMS) is a rare but potentially fatal disorder characterized by hyperthermia, muscle rigidity, altered consciousness, and autonomic dysfunction as a complication of treatment with neuroleptic drugs. Symptoms similar to NMS have been reported in non-schizophrenic patients treated with dopamine-depleting drugs (such as reserpine), following withdrawal of indirect dopamine receptor agonists in patients with Parkinson's disease, and in association with intoxication from anticholinergic agents, amphetamines, lithium carbonate, cocaine, and phencyclidine.Diagnosis is usually based on the development of severe muscle rigidity and elevated temperature in patients treated with neuroleptic drugs that is accompanied by some combination of autonomic dysfunction (diaphoresis, incontinence, tachycardia, elevated or labile blood pressure), dysphagia, tremor, myoclonus, changes in consciousness ranging from confusion to coma, mutism, leucocytosis, and laboratory evidence of muscle injury such as elevated creatine phosphokinase (CPK) There does not appear to be any major differences in the clinical presentation reported with the traditional neuroleptics and the newer atypical antipsychotic agents.","smq_source":"1) Levenson JL. Neuroleptic malignant syndrome. Amer J Psychiatry 1985; 142(10):1137-1145. 2) Caroff SN and Mann SC. Neuroleptic malignant syndrome. Medical Clinics of North America 1993; 77(1):185-202. 3) Neuroleptic malignant syndrome. Diagnostic and Statistical Manual of Mental Disorders (4th Ed). American Psychiatric Association: Washington DC, 1994, pg. 739-742. 4) Velamoor VR. Neuroleptic malignant syndrome: recognition, prevention and management. Drug Safety 1998; 19(1):73-82. 5) Neuroleptic malignant syndrome. Reporting Adverse Drug Reactions: Definitions of Terms and Criteria for Their Use. Bankowski Z, Bruppacher R, Crusius I et al (Eds). Council for International Organizations of Medical Sciences: Geneva, 1999, pg. 31-32. 6) Simpson GM, Pi EH, and Sramek JJ. Neuroleptic and antipsychotic drugs. Meyler's Side Effects of Drugs (14th Ed). Dukes MNG and Aronson JK (Eds). Elsevier: New York, 2000, pg. 139-163. 7) Crismon ML and Dorson PG. Schizophrenia. Pharmacotherapy: A Pathophysiologic Approach (5th Ed). DiPiro JT, Talbert RL, Yee GC et al (Eds). McGraw-Hill: New York, 2002, pg. 1219-1242. 8) Hasan S and Buckley P. Novel antipsychotics and the neuroleptic malignant syndrome: a review and critique. Amer J Psychiatry 1998; 155(8):1113-1116. 9) Caroff SN, Mann SC, and Campbell EC. Atypical antipsychotics and neuroleptic malignant syndrome. Psychiatric Annals 2000; 30(5):314-321. 10) Ananth J, Parameswaran S, and Gunatilake S et al. Neuroleptic malignant syndrome and atypical antipsychotic drugs. J Clin Psychiatry 2004; 65(4):464-470.","smq_note":"Cases to be selected for further review would include any cases reporting at least one of the PTs listed for Category A (narrow scope) or any case reporting some combination of at least one PT from each of the three groups of PTs listed as Categories B, C and D (broad scope). Category A (narrow scope) - PT Neuroleptic malignant syndrome, PT Serotonin syndrome, or PT Hyperthermia malignant representing specific reports of NMS or the similar conditions serotonin syndrome or malignant hyperthermia (which might be easily misdiagnosed as NMS). Category B, C, and D (broad scope): the definitions of category B, C, and D are as follows: Category B (fever-related PTs), Category C (muscle rigidity or injury-related PTs), Category D (other relevant NMS-related PTs, including investigation results). *Note that Category A corresponds to Category 1 as described in the CIOMS documentation. Categories B, C, and D correspond to Category 2 fever-related search terms, Category 2 muscle rigidity/injury-related search terms, and Category 2 other relevant NMS-related search terms, respectively.","MedDRA_version":26.1,"status":"A","smq_algorithm":"A or (B and C and D)","term_code":130046827,"term_level":5,"term_scope":1,"term_category":"D","term_weight":0,"term_status":"A","term_addition_version":26.1,"term_last_modified_version":26.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":124234018,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":113497668,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":135120530,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":24096848,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":98750386,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":73574372,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":71831361,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":131833661,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":34895973,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":13943325,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":71054742,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":104825059,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":550055,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":21440692,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":91023433,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":81807039,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":128091333,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":21673174,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":80775074,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":63531143,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":47042964,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":17391820,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":45130311,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":40775374,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":18563798,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":42412419,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":51183969,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":116107225,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":33774438,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":99275365,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). 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For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":33100637,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":136385584,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":105075594,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":38441973,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":49668699,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":134927662,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":40183880,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":29596956,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":16.1,"term_last_modified_version":16.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":138299485,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":16.1,"term_last_modified_version":16.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":28586538,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":16.1,"term_last_modified_version":16.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":71182618,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":16.1,"term_last_modified_version":16.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":96199415,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":16.1,"term_last_modified_version":16.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":34772763,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":3269584,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). 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For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":24405847,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":13} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":96950651,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":13} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). 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For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":45290190,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":24011142,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). 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For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":90510767,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":6996677,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). 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For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":67676520,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":36392638,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). 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For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":106783802,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":8603762,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). 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For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":114089525,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":18.1,"term_last_modified_version":18.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":49482026,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). 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For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":116291431,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":46248181,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":125327481,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":39045690,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":32663975,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":106136288,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":5552856,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":110987691,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":22173005,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":13} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":54233867,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":13} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":33466419,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":13} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":15247363,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":9442863,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":121761626,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":13} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":22306654,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":33699107,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":64101411,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":689066,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":20.1,"term_last_modified_version":20.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":55869268,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":19,"term_last_modified_version":19} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":139163773,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":19,"term_last_modified_version":19} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":24763069,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":10962932,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":22279309,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":92111168,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9,"term_last_modified_version":9} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":69402541,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":19,"term_last_modified_version":19} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":85070090,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"I","term_addition_version":9.1,"term_last_modified_version":10.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). 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For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":89537418,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":11,"term_last_modified_version":11} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":126383038,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":11,"term_last_modified_version":11} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":34626547,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":11.1,"term_last_modified_version":11.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":42559957,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":12,"term_last_modified_version":12} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":16437757,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":14,"term_last_modified_version":14} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":126763912,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":15,"term_last_modified_version":15} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":140995783,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":15,"term_last_modified_version":15} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":122212441,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":16,"term_last_modified_version":16} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":73589913,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":17.1,"term_last_modified_version":17.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":17066525,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":17.1,"term_last_modified_version":17.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":83906676,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":17.1,"term_last_modified_version":17.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":90202995,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":18,"term_last_modified_version":18} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":129779321,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":17.1,"term_last_modified_version":17.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":23745764,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":17.1,"term_last_modified_version":17.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":95649892,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":19,"term_last_modified_version":19} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":110294368,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":18.1,"term_last_modified_version":18.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":123590175,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":18.1,"term_last_modified_version":18.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":88926657,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":19,"term_last_modified_version":19} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":137835421,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":19,"term_last_modified_version":19} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":62500921,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":19,"term_last_modified_version":19} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":61952801,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":19,"term_last_modified_version":19} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":146979717,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":18.1,"term_last_modified_version":18.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":87596932,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":18.1,"term_last_modified_version":18.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":80062658,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":18.1,"term_last_modified_version":18.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":51762775,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":18.1,"term_last_modified_version":18.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":26370773,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":19,"term_last_modified_version":19} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":63828384,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24,"term_last_modified_version":24} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":140878150,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24,"term_last_modified_version":24} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":117930878,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":19,"term_last_modified_version":19} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":22303940,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"I","term_addition_version":19,"term_last_modified_version":19.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":42212190,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":19,"term_last_modified_version":19} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":139218396,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":19.1,"term_last_modified_version":19.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":7124971,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":19.1,"term_last_modified_version":19.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":25680727,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":20,"term_last_modified_version":20} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). 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For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":69667990,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":127447510,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":104633386,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":104816924,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":90527431,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":32359063,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":65182808,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":3483742,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":9303936,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":39120990,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":72273275,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":130813744,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24,"term_last_modified_version":24} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":49558037,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"I","term_addition_version":24,"term_last_modified_version":24} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":62982369,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24.1,"term_last_modified_version":24.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":15200402,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24.1,"term_last_modified_version":24.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":110420847,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24.1,"term_last_modified_version":24.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":137063839,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":25,"term_last_modified_version":25} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":43578412,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":25.1,"term_last_modified_version":25.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":69359404,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":25.1,"term_last_modified_version":25.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":25114201,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":25.1,"term_last_modified_version":25.1} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":40093871,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":58196243,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":110024728,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":103615311,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":17214689,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":861921,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":92777096,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":70272710,"smq_name":"Myocardial infarction (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":19732086,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":47856351,"smq_name":"Ischaemic central nervous system vascular conditions (SMQ)","smq_level":3,"smq_description":"This SMQ is a sub-SMQ of Central nervous system vascular disorders (SMQ). For a detailed description, please refer to the one in Central nervous system vascular disorders (SMQ).","smq_source":"The Merck Manual (Seventeenth Edition), 1999","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":21409048,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":47856351,"smq_name":"Ischaemic central nervous system vascular conditions (SMQ)","smq_level":3,"smq_description":"This SMQ is a sub-SMQ of Central nervous system vascular disorders (SMQ). For a detailed description, please refer to the one in Central nervous system vascular disorders (SMQ).","smq_source":"The Merck Manual (Seventeenth Edition), 1999","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":70133670,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":47856351,"smq_name":"Ischaemic central nervous system vascular conditions (SMQ)","smq_level":3,"smq_description":"This SMQ is a sub-SMQ of Central nervous system vascular disorders (SMQ). For a detailed description, please refer to the one in Central nervous system vascular disorders (SMQ).","smq_source":"The Merck Manual (Seventeenth Edition), 1999","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":139730379,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":16.1,"term_last_modified_version":16.1} {"smq_code":47856351,"smq_name":"Ischaemic central nervous system vascular conditions (SMQ)","smq_level":3,"smq_description":"This SMQ is a sub-SMQ of Central nervous system vascular disorders (SMQ). For a detailed description, please refer to the one in Central nervous system vascular disorders (SMQ).","smq_source":"The Merck Manual (Seventeenth Edition), 1999","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":91688308,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":47856351,"smq_name":"Ischaemic central nervous system vascular conditions (SMQ)","smq_level":3,"smq_description":"This SMQ is a sub-SMQ of Central nervous system vascular disorders (SMQ). For a detailed description, please refer to the one in Central nervous system vascular disorders (SMQ).","smq_source":"The Merck Manual (Seventeenth Edition), 1999","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":6130584,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":47856351,"smq_name":"Ischaemic central nervous system vascular conditions (SMQ)","smq_level":3,"smq_description":"This SMQ is a sub-SMQ of Central nervous system vascular disorders (SMQ). For a detailed description, please refer to the one in Central nervous system vascular disorders (SMQ).","smq_source":"The Merck Manual (Seventeenth Edition), 1999","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":14626518,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":47856351,"smq_name":"Ischaemic central nervous system vascular conditions (SMQ)","smq_level":3,"smq_description":"This SMQ is a sub-SMQ of Central nervous system vascular disorders (SMQ). For a detailed description, please refer to the one in Central nervous system vascular disorders (SMQ).","smq_source":"The Merck Manual (Seventeenth Edition), 1999","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":103833122,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":47856351,"smq_name":"Ischaemic central nervous system vascular conditions (SMQ)","smq_level":3,"smq_description":"This SMQ is a sub-SMQ of Central nervous system vascular disorders (SMQ). For a detailed description, please refer to the one in Central nervous system vascular disorders (SMQ).","smq_source":"The Merck Manual (Seventeenth Edition), 1999","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":113872279,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":47856351,"smq_name":"Ischaemic central nervous system vascular conditions (SMQ)","smq_level":3,"smq_description":"This SMQ is a sub-SMQ of Central nervous system vascular disorders (SMQ). For a detailed description, please refer to the one in Central nervous system vascular disorders (SMQ).","smq_source":"The Merck Manual (Seventeenth Edition), 1999","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":52885414,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":47856351,"smq_name":"Ischaemic central nervous system vascular conditions (SMQ)","smq_level":3,"smq_description":"This SMQ is a sub-SMQ of Central nervous system vascular disorders (SMQ). For a detailed description, please refer to the one in Central nervous system vascular disorders (SMQ).","smq_source":"The Merck Manual (Seventeenth Edition), 1999","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":29019438,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":47856351,"smq_name":"Ischaemic central nervous system vascular conditions (SMQ)","smq_level":3,"smq_description":"This SMQ is a sub-SMQ of Central nervous system vascular disorders (SMQ). For a detailed description, please refer to the one in Central nervous system vascular disorders (SMQ).","smq_source":"The Merck Manual (Seventeenth Edition), 1999","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":68060782,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":47856351,"smq_name":"Ischaemic central nervous system vascular conditions (SMQ)","smq_level":3,"smq_description":"This SMQ is a sub-SMQ of Central nervous system vascular disorders (SMQ). For a detailed description, please refer to the one in Central nervous system vascular disorders (SMQ).","smq_source":"The Merck Manual (Seventeenth Edition), 1999","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":58765124,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":47856351,"smq_name":"Ischaemic central nervous system vascular conditions (SMQ)","smq_level":3,"smq_description":"This SMQ is a sub-SMQ of Central nervous system vascular disorders (SMQ). For a detailed description, please refer to the one in Central nervous system vascular disorders (SMQ).","smq_source":"The Merck Manual (Seventeenth Edition), 1999","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":28076762,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":15.1,"term_last_modified_version":15.1} {"smq_code":47856351,"smq_name":"Ischaemic central nervous system vascular conditions (SMQ)","smq_level":3,"smq_description":"This SMQ is a sub-SMQ of Central nervous system vascular disorders (SMQ). For a detailed description, please refer to the one in Central nervous system vascular disorders (SMQ).","smq_source":"The Merck Manual (Seventeenth Edition), 1999","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":15298871,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":47856351,"smq_name":"Ischaemic central nervous system vascular conditions (SMQ)","smq_level":3,"smq_description":"This SMQ is a sub-SMQ of Central nervous system vascular disorders (SMQ). For a detailed description, please refer to the one in Central nervous system vascular disorders (SMQ).","smq_source":"The Merck Manual (Seventeenth Edition), 1999","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":24897186,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":47856351,"smq_name":"Ischaemic central nervous system vascular conditions (SMQ)","smq_level":3,"smq_description":"This SMQ is a sub-SMQ of Central nervous system vascular disorders (SMQ). For a detailed description, please refer to the one in Central nervous system vascular disorders (SMQ).","smq_source":"The Merck Manual (Seventeenth Edition), 1999","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":67955274,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":47856351,"smq_name":"Ischaemic central nervous system vascular conditions (SMQ)","smq_level":3,"smq_description":"This SMQ is a sub-SMQ of Central nervous system vascular disorders (SMQ). 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For a detailed description, please refer to the one in Central nervous system vascular disorders (SMQ).","smq_source":"The Merck Manual (Seventeenth Edition), 1999","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":133491107,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":25,"term_last_modified_version":25} {"smq_code":141606822,"smq_name":"Haemorrhagic central nervous system vascular conditions (SMQ)","smq_level":3,"smq_description":"This SMQ is a sub-SMQ of Central nervous system vascular disorders (SMQ). 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For a detailed description, please refer to the one in Central nervous system vascular disorders (SMQ).","smq_source":"The Merck Manual (Seventeenth Edition), 1999","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":4939448,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":25,"term_last_modified_version":25} {"smq_code":141606822,"smq_name":"Haemorrhagic central nervous system vascular conditions (SMQ)","smq_level":3,"smq_description":"This SMQ is a sub-SMQ of Central nervous system vascular disorders (SMQ). For a detailed description, please refer to the one in Central nervous system vascular disorders (SMQ).","smq_source":"The Merck Manual (Seventeenth Edition), 1999","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":82432110,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":25.1,"term_last_modified_version":25.1} {"smq_code":141606822,"smq_name":"Haemorrhagic central nervous system vascular conditions (SMQ)","smq_level":3,"smq_description":"This SMQ is a sub-SMQ of Central nervous system vascular disorders (SMQ). For a detailed description, please refer to the one in Central nervous system vascular disorders (SMQ).","smq_source":"The Merck Manual (Seventeenth Edition), 1999","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":69528638,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":141606822,"smq_name":"Haemorrhagic central nervous system vascular conditions (SMQ)","smq_level":3,"smq_description":"This SMQ is a sub-SMQ of Central nervous system vascular disorders (SMQ). For a detailed description, please refer to the one in Central nervous system vascular disorders (SMQ).","smq_source":"The Merck Manual (Seventeenth Edition), 1999","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":16700395,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":141606822,"smq_name":"Haemorrhagic central nervous system vascular conditions (SMQ)","smq_level":3,"smq_description":"This SMQ is a sub-SMQ of Central nervous system vascular disorders (SMQ). For a detailed description, please refer to the one in Central nervous system vascular disorders (SMQ).","smq_source":"The Merck Manual (Seventeenth Edition), 1999","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":18404084,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":141606822,"smq_name":"Haemorrhagic central nervous system vascular conditions (SMQ)","smq_level":3,"smq_description":"This SMQ is a sub-SMQ of Central nervous system vascular disorders (SMQ). For a detailed description, please refer to the one in Central nervous system vascular disorders (SMQ).","smq_source":"The Merck Manual (Seventeenth Edition), 1999","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":28960704,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26.1,"term_last_modified_version":26.1} {"smq_code":141606822,"smq_name":"Haemorrhagic central nervous system vascular conditions (SMQ)","smq_level":3,"smq_description":"This SMQ is a sub-SMQ of Central nervous system vascular disorders (SMQ). For a detailed description, please refer to the one in Central nervous system vascular disorders (SMQ).","smq_source":"The Merck Manual (Seventeenth Edition), 1999","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":92461156,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26.1,"term_last_modified_version":26.1} {"smq_code":141606822,"smq_name":"Haemorrhagic central nervous system vascular conditions (SMQ)","smq_level":3,"smq_description":"This SMQ is a sub-SMQ of Central nervous system vascular disorders (SMQ). For a detailed description, please refer to the one in Central nervous system vascular disorders (SMQ).","smq_source":"The Merck Manual (Seventeenth Edition), 1999","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":124736273,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26.1,"term_last_modified_version":26.1} {"smq_code":141606822,"smq_name":"Haemorrhagic central nervous system vascular conditions (SMQ)","smq_level":3,"smq_description":"This SMQ is a sub-SMQ of Central nervous system vascular disorders (SMQ). For a detailed description, please refer to the one in Central nervous system vascular disorders (SMQ).","smq_source":"The Merck Manual (Seventeenth Edition), 1999","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":52871281,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26.1,"term_last_modified_version":26.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":25943564,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":77183473,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":18} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":51188305,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":127009543,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":112421233,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":21} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":121546006,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":132522498,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":133401415,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":79839595,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":124719763,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":32889747,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":88727588,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":23201996,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":104080187,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":89309598,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":16763444,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":90977268,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":105842190,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":26204737,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":85349378,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":64238608,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":149196007,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":10053588,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":70526024,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":12.1,"term_last_modified_version":12.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":37080843,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":106425680,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":12.1,"term_last_modified_version":12.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":104130676,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":104688190,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":42185831,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":12.1,"term_last_modified_version":12.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":113336413,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":12.1,"term_last_modified_version":12.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":95787623,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":12.1,"term_last_modified_version":12.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":136679797,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":12.1,"term_last_modified_version":12.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":99738588,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":12.1,"term_last_modified_version":12.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":119439867,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":12.1,"term_last_modified_version":12.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":139400334,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":12.1,"term_last_modified_version":12.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":5316970,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":12.1,"term_last_modified_version":12.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":41027311,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":12.1,"term_last_modified_version":12.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":145495741,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":7394796,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":125603264,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":49053796,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":16289699,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":148496325,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":9907814,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":109662958,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":85205562,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":35239208,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":102257500,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":78777581,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":136512229,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":23} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":103871109,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":32333607,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":145995986,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":115226053,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":35083742,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":21} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":15461045,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":21} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":9118946,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":21} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":139715128,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":21} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":39581317,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":21} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":21994303,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":127654053,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":29615623,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":34501944,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":126298041,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":83475039,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":10,"term_last_modified_version":10} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":138352505,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":105601403,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":128637102,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":18} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":40769203,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":120364189,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":140624545,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":10256917,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":33197138,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":121512594,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":110364601,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":73854981,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":125489896,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":148689541,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":120846723,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":3581779,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":133753722,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":131893796,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":44728902,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":138166785,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":108990343,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":107972722,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":112346602,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":59649807,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":17036735,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":4829802,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":33369255,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":40238875,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":14764326,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":25452633,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":96220238,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":49074752,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":23100113,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":47206290,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":142032594,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":83925751,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":92610783,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":18.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":20534797,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":113627683,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":25140274,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":58190948,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":16591081,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":79370031,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":16574427,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":29517775,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":1465760,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":138508766,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":130232875,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":12.1,"term_last_modified_version":12.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":45058581,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":37772190,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":53452693,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":27528641,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":133140192,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":32947653,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":147878229,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":13296652,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":12.1,"term_last_modified_version":12.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":94116186,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":12.1,"term_last_modified_version":12.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":102533399,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":121127807,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":124337587,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":120782985,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":138546027,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":17281382,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":22764693,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":124146190,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":76291249,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":33720002,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":63587470,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":112024050,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":123942921,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":39565884,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":2073820,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":104994644,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":101369886,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":106522919,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":76376729,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":96353291,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":38749473,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":9.1,"term_last_modified_version":9.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":106800990,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":10.1,"term_last_modified_version":10.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":3564247,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":11.1,"term_last_modified_version":11.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":40723716,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":11.1,"term_last_modified_version":11.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":112850553,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":12,"term_last_modified_version":12} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":33714526,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":12,"term_last_modified_version":12} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":8701800,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":12,"term_last_modified_version":18} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":14384801,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":13,"term_last_modified_version":13} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":45971294,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":13.1,"term_last_modified_version":13.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":75347704,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":13.1,"term_last_modified_version":13.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":102916374,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":15,"term_last_modified_version":15} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":101314455,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":15,"term_last_modified_version":15} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":96608403,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":17,"term_last_modified_version":17} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":46374007,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":17.1,"term_last_modified_version":17.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":73419506,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":21,"term_last_modified_version":21} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":102012627,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":19.1,"term_last_modified_version":19.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":20172545,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":20,"term_last_modified_version":20} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":40494079,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":20.1,"term_last_modified_version":20.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":40360351,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":20.1,"term_last_modified_version":20.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":81003082,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":20.1,"term_last_modified_version":20.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":41219555,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":21,"term_last_modified_version":21} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":86616946,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":21,"term_last_modified_version":21} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":43916064,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":21,"term_last_modified_version":21} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":94361730,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22,"term_last_modified_version":22} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":134275157,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22,"term_last_modified_version":22} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":93730004,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22,"term_last_modified_version":22} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":149595388,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":99238756,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":133996784,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":131590035,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":8240675,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":145890923,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":33438976,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":56772185,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":36731136,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":62180863,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":30968065,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":57419032,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24,"term_last_modified_version":24} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":771668,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24,"term_last_modified_version":24} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":126946853,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24.1,"term_last_modified_version":24.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":74271008,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24.1,"term_last_modified_version":24.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":88440570,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24.1,"term_last_modified_version":24.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":4481800,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":25.1,"term_last_modified_version":25.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":49207583,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":25.1,"term_last_modified_version":25.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":23757238,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":52557088,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26.1,"term_last_modified_version":26.1} {"smq_code":95487402,"smq_name":"Toxic-septic shock conditions (SMQ)","smq_level":2,"smq_description":"A condition of profound and generally acute hemodynamic and metabolic disturbance characterized by failure of the circulatory system to maintain adequate perfusion of vital organs - Clinical indicators: o Reduced mean arterial pressure, tachycardia, tachypnea, cool skin and extremities, acutely altered mental status, oliguria, hypotension (usually, but not always, present), narrow differential pressure (difference between systolic and diastolic blood pressure), low cardiac output leading to a delayed capillary refill o End result is tissue hypoxia, often manifested by lactic acidosis - Clinical manifestations of hypovolemic or cardiogenic shock: o Hypotension, hyperventilation, cold, clammy, cyanotic skin, a weak and rapid pulse, oliguria, mental confusion, and combativeness or anxiety - Clinical manifestations of septic shock: o Chills and fever, warm flushed skin, a lower degree of hypotension, and an increase in cardiac output o If unresponsive to therapy, septic shock progresses to the clinical pattern described for hypovolemic and cardiogenic shock - Septic o Caused by the systemic reaction to severe infection with participation of biologically active soluble mediators","smq_source":"1. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1581, 1600-1605 2. Dorland's Illustrated Medical Dictionary, 28th ed, Philadelphia WB Saunders Co. 3. Reporting Adverse Drug Reactions, Definitions and Criteria for Their Use, CIOMS, Geneva, 1999 4. Harrison's Principles of Internal Medicine 16th ed, Mc Graw Hill, 2005, pp 1367-71","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":93222203,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26.1,"term_last_modified_version":26.1} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":85288735,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":10,"term_last_modified_version":10} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":109659678,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":10,"term_last_modified_version":10} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":126191842,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":10,"term_last_modified_version":10} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). 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For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":73027984,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"I","term_addition_version":10,"term_last_modified_version":17} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). 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For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":33936246,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":14.1,"term_last_modified_version":14.1} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). 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For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":70698983,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":10,"term_last_modified_version":10} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). 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For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":124595099,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":10,"term_last_modified_version":10} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). 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For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":132691070,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":14.1,"term_last_modified_version":24.1} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). 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For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":1589922,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":10,"term_last_modified_version":10} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). 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For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":69699289,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":10,"term_last_modified_version":10} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":113390302,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":10,"term_last_modified_version":10} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":9562605,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":14.1,"term_last_modified_version":14.1} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). 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For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":70094000,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"I","term_addition_version":10,"term_last_modified_version":17} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). 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For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":127662888,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":17.1,"term_last_modified_version":17.1} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). 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For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":92160117,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":10,"term_last_modified_version":10} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":71721337,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":10,"term_last_modified_version":10} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). 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For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":120133013,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":10,"term_last_modified_version":10} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). 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For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":128240132,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":10,"term_last_modified_version":10} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). 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For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":106711654,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":10,"term_last_modified_version":10} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":149913765,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":10,"term_last_modified_version":10} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). 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For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":101985456,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":10,"term_last_modified_version":17} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). 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For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":116167560,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":10,"term_last_modified_version":10} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). 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For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":70012595,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":10,"term_last_modified_version":10} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). 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For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":76856857,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":10,"term_last_modified_version":10} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":19096646,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":10,"term_last_modified_version":10} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":113580750,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":10,"term_last_modified_version":10} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":4205054,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":10,"term_last_modified_version":10} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":23552550,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":10,"term_last_modified_version":10} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":55282022,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":10,"term_last_modified_version":10} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). 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For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":25213786,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":10,"term_last_modified_version":10} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). 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For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":125376478,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"I","term_addition_version":10.1,"term_last_modified_version":18.1} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). 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For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":54741662,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":12,"term_last_modified_version":12} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":64044031,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":12,"term_last_modified_version":12} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":18494820,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"I","term_addition_version":12.1,"term_last_modified_version":15.1} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). 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For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":24987800,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":16.1,"term_last_modified_version":16.1} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). 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For detailed description, please refer to the one in Embolic and thrombotic events (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":137922497,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"I","term_addition_version":22.1,"term_last_modified_version":24.1} {"smq_code":101948271,"smq_name":"Embolic and thrombotic events, venous (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Embolic and thrombotic events (SMQ). 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For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":31360225,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23.1} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":121321332,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23.1} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":110020694,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23.1} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":28220379,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23.1} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":137338148,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23.1} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":128854958,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23.1} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":126717627,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23.1} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":132798279,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23.1} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":125077852,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23.1} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":13041436,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23.1} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":98452220,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23.1} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":76283000,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":47922229,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":89246016,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":57078449,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":33664147,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":131480380,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":130874794,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":34587131,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":104202918,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":52042811,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":29685635,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":35690259,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":69310970,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":109637582,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":64541383,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":72273275,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":58974128,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":49558037,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24,"term_last_modified_version":24} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":23296820,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24,"term_last_modified_version":24} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":127456476,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24.1,"term_last_modified_version":24.1} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":66210030,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24.1,"term_last_modified_version":24.1} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":119729674,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":25,"term_last_modified_version":25} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":63766180,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":101741397,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":145199423,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":36284555,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":145872413,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":41488990,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":19732086,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":78633571,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":105982878,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":146302418,"smq_name":"Other ischaemic heart disease (SMQ)","smq_level":2,"smq_description":"This SMQ is a sub-SMQ of Ischaemic heart disease (SMQ). For detailed description, please refer to the one in Ischaemic heart disease (SMQ).","smq_source":"","smq_note":"","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":77842824,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26.1,"term_last_modified_version":26.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":24712221,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":108964475,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":18415479,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":111498501,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":57341005,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":38666745,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":120867694,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":63538233,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":17616367,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":56155828,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":143679585,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":69816171,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":13187540,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":54390304,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":136500800,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":110275364,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":141480734,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":3365744,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":127497972,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":14165105,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":5607154,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":74872452,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":40832306,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":86109057,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":40900795,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":61011045,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":145495741,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":20912755,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":107368902,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":88300412,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":118293741,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":86488744,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":88099277,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":15551158,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":128356205,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":149119322,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":131893714,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":65577498,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":118308522,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":60701158,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":80340894,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":94242289,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":44651244,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":10005933,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":3490647,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":105877296,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":107852459,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":51707703,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":102340255,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":45583864,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":120886176,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":46291234,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":127105120,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":81539414,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":126120095,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":5819215,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":35083742,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":15461045,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":9118946,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":139715128,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":39581317,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":91868660,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":72234063,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":125986829,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":29836315,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":27260748,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":133351551,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":133712269,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":35488577,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":40713123,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":129642346,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":9879593,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":31987090,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":114183356,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":111779091,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":131796548,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":33023905,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":129017345,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":28303475,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":4748704,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":92226853,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":89298123,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":116331704,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":48638513,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":72211855,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":113076620,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":77851212,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":44395711,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":30609287,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":100928827,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":101082606,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":2190028,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":40821685,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":35575223,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":104077834,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":23503717,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":12736576,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":115734680,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":74376157,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":100741052,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":78188555,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":14620036,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":93420083,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":27218604,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":103752749,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":118559439,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":71969495,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":108861503,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":123348201,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":112346602,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":19189985,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":21782825,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":57509840,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":28792959,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":36052698,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":48468557,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":140216721,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":106980913,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":69977954,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":149854040,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":65117086,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":86206425,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":1856017,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":33747962,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":66381463,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":78674383,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":13144516,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":111962820,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":34358779,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":81232705,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":79813759,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":64763005,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":45335520,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":96083877,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":63692167,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":42789386,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":92377516,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":83925751,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":140595425,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":38641835,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":130875160,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":36046300,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":16574427,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":75408305,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":29517775,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":113380856,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":39155333,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":132201412,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":1465760,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":109329212,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":6847779,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":138508766,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":72823734,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":45058581,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":2561947,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":100350382,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":11285690,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":28426296,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":69548027,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":133140101,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":123788189,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":69561018,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":37772190,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":53452693,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":27528641,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":133140192,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":83226177,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":107089482,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":26508917,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":89189778,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":121417623,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":65118670,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":147950063,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":119141574,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":36733110,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":146209540,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":122186704,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":36966631,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":99675739,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":138084892,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":64002653,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":33320570,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":137181473,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":106082956,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":144999157,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":111802871,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":7687078,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":144366177,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":69934586,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":87352678,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":75987892,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":106605085,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":119844152,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":103327107,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":148689127,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":138546027,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":850432,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":11256529,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":53353041,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":143118506,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":43661559,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":39548063,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":60882990,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":58675571,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":25175248,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":57155409,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":402306,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":31308319,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":24749809,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":134410748,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":5188085,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":14760753,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":79138042,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":11118166,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":41463398,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":105746822,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":139706987,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":129516350,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":130837950,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":141498583,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":5357758,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":134088227,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":147319794,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":13994857,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":113949531,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":26771816,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":83357008,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":97634575,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":138827366,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":74084628,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":59987822,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":119044145,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":19858489,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":17513625,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":44002586,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":25873836,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":124298951,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":111976640,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":109618104,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":138540092,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":25790252,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":25967602,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":37383605,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":144078266,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":131914362,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":116921374,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":144797640,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":99764641,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":108935819,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":35808720,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":91477409,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":75256472,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":107628583,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":63149755,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":128803453,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":23215235,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":36148837,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":3503133,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":100177261,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":122605063,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":129938451,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":8371414,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":45266109,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":76621321,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":23278816,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":88082600,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":70765627,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":136822376,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":140389073,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":52574283,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":15746077,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":91346894,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":91666711,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":117973139,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":3945198,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":131230326,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":118357836,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":44835280,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":72961696,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":98709766,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":44780729,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":16218572,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":78389310,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":58895786,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":127762748,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":116440378,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":16616377,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":114042062,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":7493367,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":89123636,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":79579041,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":34002732,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":50650375,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":34603585,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":149496873,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":138786488,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":77206424,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":61555999,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":86020546,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":44302706,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":14391828,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":69211038,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":66560283,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":23012164,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":149315873,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":119701837,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":63374743,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":80826343,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":23282592,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":141408938,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":127229289,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":70392892,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":17409762,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":112240381,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":89108301,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":3963079,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":75213809,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":116150193,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":40742237,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":121203871,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":20442830,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":122447889,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":112387952,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":108723614,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":18039298,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":82539422,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":94467894,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":140092163,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":18470726,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":111816039,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":103093173,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":156548,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":13195559,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":59007245,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":119493720,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":13407477,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":148297453,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":121305866,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":83028825,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":142681266,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":24794871,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":141753913,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":43678744,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":63061530,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":124574964,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":16445676,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":25673950,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":95975633,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":60903414,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":36341101,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":96339529,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":25669974,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":30940938,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":55114758,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":47188270,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":69797157,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":119847107,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":24.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":53703845,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":12427933,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":32524608,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":98924709,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":111375384,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":46857322,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":133078179,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":112023601,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":58364983,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":27010693,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":146175354,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":50483191,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":136436002,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":125174905,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":38987636,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":6501972,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"I","term_addition_version":22.1,"term_last_modified_version":26.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":145674788,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":78874578,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":14238564,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":144905989,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":131620800,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":25.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":37515942,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":63745484,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":136746290,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":82838411,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":102142430,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":112771005,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":46458247,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":99441505,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":21912163,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":137519023,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":65312730,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":51369210,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":145372226,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":120086248,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":119320221,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":131913834,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":73309232,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":84796286,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":19635465,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":63975995,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":22780596,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":23} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":141767371,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":33206272,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":1520459,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":11998814,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":88405006,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":85608184,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":50292167,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":99100595,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":133234239,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":129385389,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":73419506,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":114928824,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":6182892,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":106034515,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":72686129,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":37035543,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":143933425,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":52500376,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":76119800,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":117816266,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":22270548,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":120654794,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":135632533,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":89611119,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":48062588,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":105913524,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":29728287,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":58764901,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":105917714,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":41100300,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":131679871,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":94897194,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":97652260,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":118902095,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":83930705,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":17633515,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":92555992,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":72565398,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":47529564,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":109814974,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":44686658,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":23343081,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":122883772,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":21713663,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":103839644,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":89371533,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":27445454,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":147261593,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":30126428,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":137922497,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":129516175,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":6768397,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":22.1,"term_last_modified_version":22.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":123221283,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":130507540,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":53236001,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":26442570,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":64998024,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":110297756,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":62581780,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":138776850,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23,"term_last_modified_version":23} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":59520248,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":67352379,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":138195141,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":27301593,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":87308896,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":131590035,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":63044234,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":7983637,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":52445205,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":23.1,"term_last_modified_version":23.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":145890923,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"I","term_addition_version":23.1,"term_last_modified_version":24.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":33438976,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"I","term_addition_version":23.1,"term_last_modified_version":24.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":56772185,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"I","term_addition_version":23.1,"term_last_modified_version":24.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":36731136,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"I","term_addition_version":23.1,"term_last_modified_version":24.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":62180863,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"I","term_addition_version":23.1,"term_last_modified_version":24.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":30968065,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"I","term_addition_version":23.1,"term_last_modified_version":24.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":105366653,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24,"term_last_modified_version":24} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":105591074,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24,"term_last_modified_version":24} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":64171230,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24,"term_last_modified_version":24} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":64760955,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24,"term_last_modified_version":24} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":55251343,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24,"term_last_modified_version":24} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":29156297,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24,"term_last_modified_version":24} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":57318362,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24,"term_last_modified_version":24} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":15978624,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24,"term_last_modified_version":24} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":124230796,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24,"term_last_modified_version":24} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":91516504,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24,"term_last_modified_version":24} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":63412927,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24,"term_last_modified_version":24} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":22046099,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24,"term_last_modified_version":24} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":23296160,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24,"term_last_modified_version":24} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":128035510,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24,"term_last_modified_version":24} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":32077316,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24.1,"term_last_modified_version":24.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":79053099,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24.1,"term_last_modified_version":24.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":91798936,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24.1,"term_last_modified_version":24.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":11082867,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24.1,"term_last_modified_version":24.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":21885260,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24.1,"term_last_modified_version":24.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":122407304,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24.1,"term_last_modified_version":24.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":31161102,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":24.1,"term_last_modified_version":24.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":24038655,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":25,"term_last_modified_version":25} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":14700741,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":25,"term_last_modified_version":25} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":147715549,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":25,"term_last_modified_version":25} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":11970846,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":25.1,"term_last_modified_version":25.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":100544893,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":91890931,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":4440567,"term_level":4,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":48231610,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":128157222,"term_level":4,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":105143703,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":80368307,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":28181549,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":15981297,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":125281267,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":34957116,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":110295330,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":87827945,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":26027006,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":97258895,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":23757238,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26,"term_last_modified_version":26} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":27841439,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26.1,"term_last_modified_version":26.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":15823375,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26.1,"term_last_modified_version":26.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":140282333,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26.1,"term_last_modified_version":26.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":117923381,"term_level":5,"term_scope":1,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26.1,"term_last_modified_version":26.1} {"smq_code":94479717,"smq_name":"Sepsis (SMQ)","smq_level":1,"smq_description":"Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection. Sepsis is caused by an infection of any organisms including bacterial, fungal and viral agents. In patients with an intact immune system, gram-positive and gram-negative bacteria are the most common cause. In patients with a compromised immune system, uncommon bacterial and fungal species are more commonly the cause. Many factors increase the risk of developing sepsis including indwelling vascular catheters or other invasive devices, recent surgical procedures, diabetes mellitus, cirrhosis, and compromised immune systems. Common sites of infection include the urinary, biliary, and gastrointestinal tracts as well as the lungs. Clinical signs are often non-specific but may include signs of infection including fever, tachycardia, and diaphoresis. As the condition deteriorates, signs and symptoms consistent with end-organ damage can present. Diagnosis of sepsis requires a combination of clinical signs and symptoms along with positive cultures of blood, urine or other sites of infection. Control of the infectious source should be undertaken promptly. All invasive devices should be removed or changed if possible; necrotic tissue and abscesses should be addressed. Treatment of sepsis centers on broad-spectrum antibiotics and supportive treatment with vasopressors, IV fluids, oxygen, and corticosteroids. Patients with septic shock generally require intensive care. Blood sugar control is critical for patients with diabetes as hyperglycemia will impede the ability to respond adequately to the infection.","smq_source":"1. Merck Manual, Professional version; February 2018. 2. Rhodes, A., et al. (2017). Surviving Sepsis Campaign: International guidelines for management of sepsis and septic shock: 2016. Critical Care Medicine, 45 (3), 486-552. 3. World Health Organization (2017). Improving the prevention, diagnosis, and clinical management of sepsis. Seventieth World Health Assembly A70/13. 4. Singer, M., et al. (2016). The third international consensus definitions for sepsis and septic shock (Sepsis-3). JAMA, 315(8): 801-10.","smq_note":"NOTE: It may be necessary to combine Sepsis (SMQ), Agranulocytosis (SMQ), and Toxic-septic shock conditions (SMQ) to perform a comprehensive search.","MedDRA_version":26.1,"status":"A","smq_algorithm":"N","term_code":27909669,"term_level":5,"term_scope":2,"term_category":"A","term_weight":0,"term_status":"A","term_addition_version":26.1,"term_last_modified_version":26.1}