adverse event (AE)

Abstract

ICH: “any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment”; any undesirable experience occurring to a subject during a clinical treatment, whether or not considered related to the (investigational) product(s); expected AE = event which is already known from previous experiences and described in the investigator’s brochure or package insert; techniques to evaluate AEs are e.g.: case control studies, post-marketing surveillance programmes, prescriptionevent monitoring, prescription-sequence analyses etc.; when an AE has been assessed (→ see standardised assessment of causality) and there are reasonable grounds for the suspicion that it is causally related to the (investigational) drug(s), it must be considered as an adverse drug reaction; for regulatory reporting purposes, if an event is spontaneously reported, even if the relationship is unknown or unstated, it meets the definition of an ADR; → see also adverse experience, adverse reaction, blinding, concomitant event, incident, medical device reporting, pharmacovigilance, rule of three, safety update report, significant adverse event, unexpected adverse event.