Serious Adverse Event (SAE)

An adverse event that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, causes a congenital anomaly or birth defect, or is an important medical event that may jeopardize the patient. SAEs require expedited reporting to regulatory authorities (within 7-15 days) and the study sponsor regardless of causality assessment.

أمثلة

• Anaphylaxis requiring ICU admission after monoclonal antibody infusion
• Drug-induced liver failure requiring liver transplant (Hy's Law case)
• Rhabdomyolysis with hospitalization during statin therapy (cerivastatin, withdrawn 2001)