adverse event


adverse event

"Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment." [International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.]
See also: adverse drug event.

adverse event

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 that treatment. An adverse event can thus be any abnormal laboratory finding, symptom or disease temporally associated with the use of a medicinal (investigational) product, whether or not caused by that product.

adverse event

Malpractice An injury caused by medical management–rather than by the underlying disease–which prolongs hospitalization, produces a disability at the time of discharge, or both Etiology Drug effects, wound infections, technical complications, negligence, diagnostic mishaps, therapeutic mishaps, and events occurring in the emergency room. See Malpractice, Misadventure, Negligence. Cf Adverse effect.

ad·verse e·vent

(ad-vĕrs' ĕ-vent') In nursing usage, an injury resulting from a patient's medical management rather than from the underlying condition itself.