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 ?
The author reported total mortality, serious adverse events (death, hospital admission, life-threatening events), and complicated ulcers for each study individually and a pooled estimate for both studies (median duration of 9 months).
22, 2007, all manufacturers, packers, and distributors of supplements will be required to report serious adverse events to the FDA within 15 business days through the MedWatch program.
No serious adverse events related to desloratadine syrup (0.5 mg/mL) were reported for any of the 255 infants and children, said Dr.
To characterize NVP-associated PEP toxicity, CDC and the Food and Drug Administration (FDA) reviewed MedWatch reports of serious adverse events in persons taking NVP for PEP received by FDA (Figure 1).
Fifteen patients experienced serious adverse events, including four cases of MAS (one with a lethal end), infections or flare-linked events.
"The intent and spirit of the Act is to require manufacturers to report to FDA the serious adverse events that they receive, and to assure that consumers who want to contact the manufacturer have adequate information to do so," the association said.
Serious adverse events that occurred in study participants included two perforations, and two intracerebral hemorrhages, including one that was a result of perforation, for a serious adverse event rate of 3%.
First, it requires that the manufacturer, packer or distributor whose name appears on the product label (referred to as the "responsible person") report to FDA (using the agency's "MedWatch" form) any serious adverse event associated with the product--serious is important for purposes of defining what types of events must be reported to the agency as opposed to the record keeping provisions--along with a copy of the product label within 15 business days of receiving the report.
14 September 2010 - US-based biopharmaceutical company Icagen Inc (NASDAQ: ICGN) announced yesterday that due to the occurrence of a serious adverse event in the photosensitivity study of ICA-105665, it suspended further enrollment in the study.
So far, the HPV4 overall vaccine adverse event reporting rate is 33 per 100,000 doses; the serious adverse event reporting rate is 1.8 per 100,000 doses, based on VAERS data.
First, it requires that the manufacturer, packer, or distributor whose name appears on the product label (referred to as the "responsible person") report to FDA (on the agency's "MedWatch" form) any "serious adverse event" associated with the product, along with a copy of the product label, within 15 business days of receiving the report.