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Last Updated Sunday, April 20 2014
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Adverse Event (AE)



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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