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 ?
In the Federal Register Notice, FDA estimated the annual reporting and record-keeping burden to the industry based on FDA's experience with similar adverse event reporting programs.
A number of approaches to measuring adverse event rates have been used historically, including voluntary reports ("incident reports"), mining of administrative databases, and the two-stage review process used in the Harvard Medical Practice Study (Brennan, Localio, and Laird 1989; Brennan et al.
Likewise, findings of the Vaccine Safety Datalink project--which was established in 1990 to improve the evaluation of vaccine safety through active surveillance and epidemiologic studies showed that among more than 375,000 doses administered and monitored, no statistically significant risk for any prespecified adverse event (Guillain Barre syndrome, seizures, syncope, anaphylaxis, other allergic reactions, appendicitis, stroke, and VTE) occurred after vaccination in either youth (ages 9-18 years) or adults (ages 19-26 years), Julianne Gee of the CDC reported.
This benefit comes at a cost well below traditional inpatient reviews, where less than 1% of reviews will reveal a negligent adverse event and less than half of these will result in a serious patient injury.
FDA needs authority to require mandatory adverse event reporting," says Heller.
Reid said manufacturers, distributors, hospitals and doctors file about 300,000 adverse event reports with FDA yearly.
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.
In a cohort study of 18 community-based Massachusetts nursing homes,' researchers identified 546 medication-related adverse events and 188 potential adverse events for 2,916 residents.
8 per cent of the patients had suffered an adverse event, around five per cent of which were avoidable.
Reliability is a function of the entire measurement process, which includes the precision of the instrument, the measurement procedure or method of applying the instrument, and the amount of variability of the true adverse event rate in the underlying population.
The Act imposes three main requirements concerning adverse event reporting.

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