Adverse event

Author: Prof. Dr. med. Peter Altmeyer

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Last updated on: 29.10.2020

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Adverse event; AE; UE

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An adverse event is an unwanted event (UE) that occurs in temporal relation to a clinical trial.

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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.


Last updated on: 29.10.2020