Adverse event (AE)

In the context of a clinical trial: Any untoward medical occurrence in a subject to whom a medicinal product is administered and which does not necessarily have a causal relationship with this treatment [Reg (EU) No 536/2014 Art 2(2)(32)].

A subject means an individual who participates in a clinical trial, either as recipient of an investigational medicinal product or as a control [Reg (EU) No 536/2014 Art 2(2)(17)].

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-E2D Guideline, see GVP Annex IV).

An adverse event can therefore be any unfavourable and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product (see GVP Annex IV, ICH-E2D Guideline).