Adverse Event (AE)

February 27, 2012

A negative experience encountered by an individual during the course of a clinical trial that is associated with the drug. An AE can include previously undetected symptoms, or the exacerbation of a pre-existing condition. When an AE has been determined to be related to the investigational product, it is considered an Adverse Drug Reaction. See also Serious Adverse Event (SAE).
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