Adverse Event (AE)

Adverse Event (AE)

Any untoward medical occurrence in a patient or clinical investigation subject administered a 

pharmaceutical product and which does not necessarily have a causal relationship with this 

treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign 

(including an abnormal laboratory finding), symptom, or disease temporally associated with the 

use of a medicinal (investigational) product, whether or not related to the medicinal 

(investigational) product.

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