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 ?

Admission to hospital has been identified as carrying the additional risk of unintended injury, the so called 'adverse event'.

Examining the occurrence of adverse events within 72 hours of discharge from the intensive care unit

Although the most significant increase in 2004 post-marketing reporting was for serious adverse events reported periodically, reports directly from individuals increased by 6%, expedited reports increased by 12% and non-serious periodic reports increased by 3%, Berry noted.

Serious adverse event periodic reporting increased 20% in 2004, FDAer says

"Some trusts reported zero levels of adverse events, which seems unlikely.

Hospitals `need to improve recording of errors'

Isotretinoin use may increase vulnerability to psychiatric conditions, but available evidence does not support a causal relationship, on the basis of data from a retrospective study of 17,829 psychiatric adverse events reported to the Food and Drug Administration over 2 decades.

Isotretinoin and psychiatric events: No causal link found

Number of reports (n = 102) with documented dates of administration of expired injectable influenza vaccine--Vaccine Adverse Event Reporting System, United States, July 2018-January 2019

Administration of Expired Injectable Influenza Vaccines Reported to the Vaccine Adverse Event Reporting System--United States, July 2018-March 2019

The governing agencies all have differing approaches to handling Adverse Event Reports, but in general, these reports are reviewed and evaluated for risks to animal (and/or public) health.

Reporting, Your Duty

"Can you identify these adverse events early on to keep the patients on immune checkpoint inhibitor therapy and not have to stop their cancer treatment?

FDA database reveals many rheumatic and musculoskeletal adverse events on immunotherapies

The Global Trigger Tool (GTT) was designed to measure adverse events by guiding chart reviewers to seek out specific occurrences or "triggers" that are commonly associated with an adverse event based on a review of adverse event literature (Griffin & Resar, 2009; Sharek et al., 2011).

Multicenter study of adverse events after intravenous tissue-type plasminogen activator treatment of acute ischemic stroke

There are few studies evaluating the occurrence of adverse events during intrahospital transportation of severe patients and their association with significant clinical outcomes.

Analysis of Adverse Events during Intrahospital Transportation of Critically Ill Patients

Senator Al Franken (D-Minn.) has asked federal regulators and Dublin, Ireland-based Medtronic pic for detailed data about injuries associated with the company's bone graft Infuse following a newspaper report that Medtronic hid thousands of adverse events linked to the product.

Senator asks Medtronic and FDA for bone graft injury data

Fleming said he doesn't believe any of the 2014 adverse event errors in New Hampshire resulted in death, but the detailed investigations and remedial plans are not made public.

'Never events' on the rise at NH hospitals: but reporting requirements, compliance could be source of increase

The Health Quality & Safety Commission's report on learning from adverse events, released in December 2015, included a specific focus on deteriorating patient cases.