Adverse event

Author: Prof. Dr. med. Peter Altmeyer

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Last updated on: 29.10.2020

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An adverse event (AE) is an occurrence that occurs in the temporal context of a clinical trial. In principle, a distinction is made according to the severity of the event between an adverse event and a serious adverse event (SUE). According to the GCP Ordinance or the Medical Devices Act and the German Medicines Act, a serious adverse event exists if a death of the patient, a life-threatening situation, a hospital extension or permanent damage to the patient or congenital anomalies occur.


Last updated on: 29.10.2020