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Clinical context

Adverse event

Also known as: AE

An unwanted health occurrence during treatment or research, whether or not it is shown to have been caused by the intervention.

Source-checked educational compilation · Not independently clinically reviewed

What this means in a clinic conversation

Recording an event and establishing its cause are different tasks. When reading a study, check how events were collected, how long participants were monitored and what was reported.

A question to bring

How were unwanted events monitored, and how were they judged to be related or unrelated?

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Related and commonly confused terms

Use the term in context

Sources and editorial context

This definition was compiled from the sources below and has not received independent clinical review. It supports understanding and consultation preparation.

  1. IND Application Reporting: IND Safety Reports · U.S. Food and Drug AdministrationReference checked 2026-10-02
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