SAE

SAE, or Severe Adverse Event, refers to a significant medical incident that occurs during a clinical trial or treatment, which results in serious health consequences such as death, hospitalization, disability, or birth defects. These events indicate that something potentially harmful has happened to a participant's health, often requiring immediate medical attention and investigation. SAE reporting is critical to ensure patient safety, monitor the risks of a treatment, and determine if further action or adjustments are needed to protect participants.