Serious Adverse Event (SAE)

Any untoward medical occurrence or effect that at any dose 

- requires inpatient hospitalization or prolongation of existing hospitalization, 

- results in persistent or significant disability or incapacity, 

- results in a congenital anomaly or birth defect, 

- is life-threatening or results in death.

These characteristics/ consequences of an SAE have to be considered at the time of the event. Medical and scientific judgement should be exercised in deciding whether an event is ‘serious’ in accordance with these criteria.

Example: A broken leg that occurs during participation in a clinical study and results in an inpatient hospitalization is initially classified as Serious Adverse Event, regardless of the causal relationship with the study medication or procedure.

If a SAE qualifies as a suspected Unexpected Serious Adverse Reaction (SUSAR) due to a causal relationship with the study medication or procedure, it must be reported to the competent authorities within certain time limits.