adverse event


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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.
References in periodicals archive ?
One hour to assemble and submit any follow up reports of new medical information regarding the serious adverse event report, as recommended in the guidance;
The Results: The adverse events ranged from mild (pain, bruising, bleeding and mild worsening of symptoms) to severe (thumb deformity, infections, heart rupture, lung puncture, nerve impairment, coughing up blood, coma and more).
Among comorbid conditions, the highest adverse event odds ratio was in patients with chronic renal disease, at 1.
to debrief the results of their record reviews, focusing on the cause and remediation of errors in trigger and adverse event identification and classification.
The ad hoc analysis compared the gel only to placebo, not to oral therapy, and found higher rates of adverse events for the drug vs.
Although the agency's reported information has limitations, the increase in consumer-reported adverse events is significant and could indicate greater awareness of drug safety issues.
said that the FDA and EU are implementing new requirements for the reporting of adverse drug reactions, and there are also new requirements in store for reporting adverse events with dietary supplements.
Adverse events that have been associated with smallpox vaccination are classified on the basis of evidence supporting the reported diagnoses.
FDA advises consumers and physicians in this context that a serious (reportable) adverse event is one that is fatal, life-threatening, disabling, requiring initial or prolonged hospitalization, involving a birth defect, or requiring intervention to prevent permanent damage.
This means thatusing a soft toothbrush and shaving with electric razors are interventions that might help prevent an adverse event," adding that aside from warfarin, CNAs' observations are also especially valuable when psychoactive drugs are prescribed; CNAs' constant interaction with residents allows them to monitor the effectiveness and possible side effects associated with the medications, and CNAs should be coached specifically on the side effects to watch for.
The research indicated that 850,000 people a year suffer an adverse event while in hospital and that 68,000 will die partly as a result of the event.

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