Adverse event
An adverse event or AE is any undesired adverse change in health a result of toxicity in a patient. Also: A 'side-effect' that occurs in a person who participates in a clinical trial while the patient is receiving the treatment with a study medication, an application of the study device, or within a pre-specified period of time after their treatment has been completed. Also see: ADR (Adverse Drug Reaction). Adverse events must be notified to the sponsor who is required to perform a written investigation into the cause of the event. The sponsor may need to take corrective or preventive actions to avoid futher adverese events. See: Complaints, CAPA).
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