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. 

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