Adverse event

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.