MRCT – A health problem that happens during the study and is reported as possibly caused by the study treatment.
https://mrctcenter.org/glossaryterm/adverse-reaction/
CDISC-Gloss – A response to a medicinal product, devices, or procedures, which is noxious and unintended. Response in this context means that a causal relationship between a
medicinal product and an adverse event is at least a reasonable possibility. In the context of drug development, the term is used as a synonym of adverse drug reaction. (After ICH E2A)