Serious adverse event

Serious adverse event or SAE refers to an undesirable experience associated with the use of a medical product in a patient. The term is often used in clinical trials to refer to any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect.

Definition

The Food and Drug Administration (FDA) defines a serious adverse event as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect.

Reporting

In the United States, the FDA requires that serious adverse events be reported within 15 days of their discovery. In the European Union, the European Medicines Agency (EMA) requires that all serious adverse reactions be reported within 15 days as well.

Examples

Examples of serious adverse events include death, life-threatening disease, hospitalization (initial or prolonged), disability or permanent damage, congenital anomaly or birth defect, or the need for medical or surgical intervention to prevent one of these outcomes.

See also

• Adverse event
• Adverse drug reaction
• Pharmacovigilance
• Clinical trial