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Clinical Research Terms Glossary

Serious Adverse Event (SAE)

Serious adverse events are any event that: results in death; is life threatening or place the clinical study 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; or creates another condition which investigators judge to represent significant hazards. (NIH)