Serious Adverse Event Definition. Serious adverse event (SAE) means any untoward medical occurrence that at any dose: • Results in death. • Is life-threatening (refers to an AE in which the patient was at risk of death at the time of the event. It does not refer to an event which hypothetically might have caused death if it were more severe). • Requires inpatient hospitalization or prolongation of an existing hospitalization. • Results in persistent or significant disability or incapacity (disability is defined as a substantial disruption of a person’s ability to conduct normal life functions). • Is a congenital anomaly/birth defect.
