ABSTRACT
An adverse event (AE) is any untoward medical occurrence in a subject participating in a clinical study who is administered a medical (investigational or noninvestigational) product. An AE may not necessarily relate causally to the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, event, or disease temporally associated with the use of the product, whether or not it is related to that product or device (EMA 1995, NCI 2009). An AE in a clinical trial is commonly classified based on the investigator’s judgment on
• relationship to the study medication, as definitely, probably, possibly related, or not likely related.
