CDISC-Gloss – Adverse drug reaction that at any dose of the drug: results in death, is life- threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, or is a congenital anomaly/ birth defect. NOTE: FDA 21 CFR 310.305 defines an adverse drug experience to include any adverse event, “whether or not considered to be drug related.” CDISC recognizes that current usage incorporates the concept of causality. [1. WHO Technical Report 498(1972);
2. After ICH E2A, B] See ICH E6 definition and serious and severe definitions.