Adverse event

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.