Serious Adverse Event (SAE)
An adverse event that results in death, is life-threatening, requires hospitalisation, causes persistent disability, or results in a congenital anomaly. SAEs must be reported to regulatory authorities within 24 hours and may trigger safety reviews, label changes, or market withdrawal.
Technical Context
SAE criteria (ICH E2A definition): results in death, is life-threatening (immediate risk of death at time of event), requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a medically important event that may jeopardise the patient or require intervention. SAEs must be reported to the sponsor within 24 hours. Suspected unexpected serious adverse reactions (SUSARs) — serious reactions not listed in the investigator's brochure — must be reported to regulatory authorities within 7 (fatal/life-threatening) or 15 (other serious) calendar days. SAE rates are a key safety metric in regulatory submissions and product labelling.