NCIt related terms : adverse drug experience; adverse drug reaction (ADR);
NCIt definition : Any detrimental or unintended response associated with the use of a medication in
humans.;
Alternative definition : CDISC-GLOSS: Any noxious and unintended response associated with the use of a drug
in humans. NOTE: 1. Post-approval: an adverse event that occurs at doses normally
used in man for prophylaxis, diagnosis, or therapy of diseases or for modification
of physiological function. 2. Pre-approval: an adverse event that occurs at any dose
and where a causal relationship is at least a reasonable possibility. 3. FDA 21 CFR
310.305 defines an adverse drug experience to include any adverse event, whether or
not considered to be drug-related. CDISC recognizes that current usage incorporates
the concept of causality. [WHO Technical Report 498(1972); ICH E2A];