Adverse Event (AE)

Adverse Event

Any untoward medical occurrence in a patient or clinical trial subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

In the context of pharmacovigilance and outside a clinical trial: any untoward medical occurrence in a patient to whom a medicinal product is administered and which does not necessarily have a causal relationship with this treatment (based on ICH-E2 D Guideline, see GVP Annex I)