Adverse Events
Definition
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 of
a drug is complete. Not every adverse event is causally
related to the treatment being studied, but researchers
must report all adverse events to the relevant regulatory
authority in the country where the drug is to
be registered. Adverse events categorized as “serious”
(for example death, illness requiring hospitalization,
events deemed life-threatening, etc.) must be reported
to the regulatory authorities immediately, whereas
minor adverse events are merely documented in the
annual summary sent to the regulatory authority.
Cross-References
 Adverse Drug Reaction
 Adverse Effect
 Side Effect

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