Definition

An adverse event that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, results in persistent/significant disability, is a congenital anomaly, or is an important medical event.

Example

A patient taking Drug X is hospitalized for severe allergic reaction requiring IV treatment. Even if the patient fully recovers, this is an SAE because it required inpatient hospitalization.

Regulatory source

ICH E2A, 21 CFR 312.32

Common mistakes

Confusing 'serious' with 'severe.' Severe describes intensity; serious is a regulatory classification. A severe headache is not automatically serious.

Inspector question

How do you distinguish between serious and severe? Give me an example of a severe but non-serious event and a mild but serious event.

Related terms