SAE
Also written as: SAE — Serious Adverse Event
Adverse event that results in death, hospitalization, disability, or is life-threatening or medically significant.
Full Definition
A Serious Adverse Event (SAE) is any 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, is a congenital anomaly or birth defect, or is an important medical event that may jeopardize the patient and may require medical intervention to prevent one of the other serious outcomes. In psychiatric clinical trials, SAEs require expedited reporting to regulatory authorities, typically within 24 hours of investigator awareness. Common psychiatric SAEs include suicide attempts, psychiatric hospitalizations, and severe medication reactions. The distinction between SAE and non-serious adverse events is crucial for safety monitoring and regulatory compliance.
Usage
Usage note: Always capitalize as SAE when used as acronym; spell out on first use in documents.
In Context
- "The investigator reported an SAE of suicidal ideation requiring immediate hospitalization." — Safety report
- "All SAEs must be reported to the sponsor within 24 hours of investigator awareness." — Clinical trial protocol