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Synonym(s)
AE
DefinitionThis section has been translated automatically.
An Adverse Event (AE) is an adverse event (UE) that occurs in the temporal context of a clinical trial. A distinction is made between an Adverse Event and a Serious Adverse Event (SAE) according to the severity of the event. 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.
Prof. Dr. med. Peter Altmeyer