Adverse Events (AE)

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. Therefore, an AE can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Likewise, any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with any intervention conducted due to the subject participation in the clinical trial, even if not associated to a medicinal product, should also be considered as an AE.

Note: Clinically significant abnormal laboratory findings are considered AEs, however abnormal laboratory findings may not be considered as AEs if there is no change compared to baseline values (at randomization).