Adverse event
Synonym(s)
Adverse event; AE; UE
DefinitionThis section has been translated automatically.
An adverse event is an unwanted event (UE) that occurs in temporal relation to a clinical trial.
ClassificationThis section has been translated automatically.
In principle, a distinction is made according to the severity of the event:
- Adverse Event and a
- Serious Adverse Event (SAE).
According to the GCP regulation or the Medical Devices Act and the 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.