Encyclopedia > A > Adverse event
Adverse event
An adverse event (AE) is any adverse change in health or "side-effect" that occurs in a person during a clinical trial or within a pre-specified period after dosing is complete. Not every adverse event is causally related to the treatment or test being studied, but researchers must report all adverse events to the Food and Drug Administration (FDA)or the relevant regulatory authority in the country where the drug or device is to be registered.
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