Pharmacovigilance

Adverse Event(AE)

Any untoward medical occurrence in a patient or clinical trial subject administered a pharmaceutical product.

Usage Examples

The subject reported an adverse event of mild headache.
All AEs were collected and coded using MedDRA.
The unexpected AE required expedited regulatory reporting.

What is AE?

An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, regardless of whether it is considered related to the treatment. AEs include illnesses, signs, symptoms, and abnormal laboratory findings.

AEs are categorized by severity (mild, moderate, severe), seriousness (SAE criteria), and causality (relationship to study drug). Serious Adverse Events (SAEs) include death, life-threatening events, hospitalization, disability, congenital anomaly, or other medically important events.

Prompt reporting of AEs is required during clinical trials. Sponsors must report SAEs to regulatory authorities within specific timeframes (7-15 days depending on expectedness and relationship).

Regulatory Context

This term appears most often in pharmacovigilance workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside 21 CFR 312, ICH E2A, ICH E6.

FDAEMAWHO

When This Matters

The subject reported an adverse event of mild headache.
All AEs were collected and coded using MedDRA.
The unexpected AE required expedited regulatory reporting.

Common Mistakes

Treating safety signal reviews as periodic instead of continuous.
Not linking new enforcement letters to internal CAPA and labeling workflows.
Using static templates for dynamic benefit-risk communication updates.

Related Regulations

21 CFR 312ICH E2AICH E6

Frequently Asked Questions

An SAE (Serious Adverse Event) meets specific criteria: results in death, is life-threatening, requires hospitalization, causes disability, is a congenital anomaly, or is medically significant. All SAEs are AEs, but not all AEs are SAEs.

Investigators assess whether the AE is related to study treatment using categories like definite, probable, possible, unlikely, or unrelated, based on temporal relationship, biological plausibility, and other factors.