Glossary Term
Serious Adverse Event (SAE)
Glossary Term:
Serious Adverse Event (SAE)
Definition
Any adverse event that:
- Results in death
- Is life threatening, or places the participant at immediate risk of death from the event as it occurred
- Requires or prolongs hospitalization
- Causes persistent or significant disability or incapacity
- Results in congenital anomalies or birth defects
Is another condition which investigators judge to represent significant hazards.
Sponsors may have specific definitions of what is considered an SAE.