Adverse Event (AE)

ICH E6(R3) – Any unfavourable medical occurrence in a trial participant. The adverse event does not necessarily have a causal relationship with the treatment.

MRCT – Any health problem that happens during the study. https://mrctcenter.org/glossaryterm/adverse-event/

CDISC-GLOSS – 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 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. NOTE: For further information, see the ICH Guideline for Clinical safety Data Management: Definitions and standards for expedited Reporting. [After ICH E2A] See also serious adverse event, serious adverse experience.