ICH E6(R3) – Any unfavourable medical occurrence that is considered serious at any dose if it:
• results in death
• is life-threatening
• requires inpatient hospitalisation or prolongation of existing hospitalisation
• results in persistent or significant disability/incapacity
• is a congenital anomaly/birth defect (see ICH E2A)
CDISC-Gloss – Adverse event that: 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: For further information, see the ICH Guideline for Clinical safety Data Management: Definitions and standards for expedited Reporting. [After ICH E2A, B]. Compare to serious adverse drug reaction.