serious adverse event


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Related to serious adverse event: SUSAR

serious adverse event

EBM
Any untoward medical event attributed to a therapeutic agent at any dose, which: results in death; is life threatening; requires inpatient hospitalisation or prolongation of existing hospitalisation; results in persistent or significant disability/incapacity; or causes a congenital anomaly/birth defect.
References in periodicals archive ?
For example, FDA cites instances of elevated bilirubin levels, even when there are no symptoms associated with such increased levels, as a serious adverse event.
manufacturer, packer or distributor submitting the serious adverse event report to FDA)
NPA believes that adverse events potentially related to dietary supplements will be minimal and serious adverse events rarer still.
The study defined serious adverse events as any adverse event that results in death, a life-threatening experience, inpatient hospitalization, persistent or significant disability or incapacity, or the need for medical or surgical intervention to prevent one of these events.
Among the serious adverse events reported are syncope, Guillain Barre syndrome, venous thromboembolism (VTE), and death, according to Dr.
722) requiring supplement makers to report serious adverse events to the FDA and restricting the sale of stimulants like the herb ephedra, which has been blamed for scores of deaths.
The letter, written in collaboration with the Food and Drug Administration, was intended partly to remind physicians to report any serious adverse events occurring among women who take mifepristone.
Report Serious Adverse Events Associated with Dietary Supplements Containing GHB, GBL, or BD (August 25, 1999)
The major components of the Act are increased data requirements for devices submitted under a 510k, requirement for increased postmarketing surveillance, establishment of registries for some devices, and more rigorous reporting of serious adverse events associated with the use of devices.
Wellington-based primary health care organisation, Compass Health, is supporting its general practices to actively engage in the reporting of serious adverse events.
Data collection is limited to the report of serious adverse events, and no specific laboratory testing is required except as indicated for standard medical care.
Safety results were favorable and in line with expectations, with no drug related serious adverse events being reported.