Login required. Please login into your account or register.
Synonym(s)
UE
DefinitionThis section has been translated automatically.
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.
Prof. Dr. med. Peter Altmeyer