adverse event


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adverse event

noun adversity, calamity, casualty, catastrophe, debacle, detriment, infliction, misfortune, plight, tragedy, trouble, unpropitious turn of events
See also: misfortune
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References in periodicals archive ?
An average of 2 hours per report to collect information about a serious adverse event associated with a dietary supplement and report the information to FDA on Med-Watch Form FDA 3500A;
The adverse events from each study were pooled, for a total of 249 events.
The adverse event odds ratio for treatment following transient ischemic attacks was 3.
Abnormal laboratory results, prescriptions for antidote medications, and other medical record-based "hints" can all serve to "trigger" the suggestion that an adverse event might have occurred, and that a more thorough review of the medical record is indicated.
Overall, 56% of patients on diclofenac gel developed adverse events, compared with 44% of 264 patients treated with placebo gel, added Dr.
Consumers reported 174,216 adverse events in 2007--53,216 more than reported by physicians, according to the data.
The FDA does have a voluntary system in place for reporting adverse events--the Center for Food Safety and Applied Nutrition Adverse Event Reporting System is a computerized database of records submitted by consumers, health care providers, and industry.
Adverse Event Reporting is published every other Monday, in PDF format only.
In this vaccination program, CDC, the Food and Drug Administration, and state health departments are conducting surveillance for vaccine-associated adverse events among civilian vaccinees (1,2).
Specifically, GAO (1) examined the extent to which consumer information in the call records was comprehensive, interpretable, and consistently recorded, (2) counted the number of call records reporting types of adverse events that FDA had identified in 1997 as serious or potentially serious, and (3) compared GAO's findings to those of six other reviews of the call records, including one by Metabolife International.
FDA's letter says essentially four things: (1) It announces the development of a comprehensive program to track and analyze adverse event reports involving foods, dietary supplements and cosmetics; (2) It announces that FDA will notify manufacturers when it receives an adverse event report involving one of their products; (3) It encourages companies to share with FDA adverse event information they are aware of; (4) Finally, it announces that FDA is evaluating how best to provide adverse event information to the public on a user-friendly Web site.

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