<P> An adverse event ( AE ) is 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 . </P>
mandatory elements in the definition of an adverse event ( ae )
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