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adverse event - AE

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Begriff Definition
adverse event - AE
An Adverse event (AE) means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device.
For more safety-related terms see also serious adverse event, adverse device effect, serious adverse device effect, device deficiency and incident.