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 ?
These results have energized our interest in exploring the genome to gain a better understanding of rare, serious adverse events and lay the foundation for our Stage 2 Research effort.
The agency thereby made clear that it considered such reports to be serious adverse event reports, going on to note that "loss of sense of smell can have serious consequences.
Serious adverse events are defined as those that result in death, a life-threatening experience, inpatient hospitalization, persistent or significant disability or incapacity, or a congenital abnormality or birth defect; or that require, based on reasonable medical judgment, a medical or surgical intervention to prevent one of these outcomes.
In this regard, the script and form should be developed to elicit easy-to-understand but simple answers from the caller that capture the relevant information necessary to determine whether there is a serious adverse event and to properly fill out MedWatch Form 3500A.
NPA believes that adverse events potentially related to dietary supplements will be minimal and serious adverse events rarer still.
Serious adverse events associated with the vaccine can include anaphylaxis, yellow fever-associated neurologic disease, and yellow fever vaccine--associated viscerotropic disease, she said.
There were no serious adverse events related to the use of the study drug, and also no evidence of treatment-induced insulin antibodies occurring in patients, the company said.
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.
Complaints are screened for serious adverse events and appropriate action is taken by the departmental Serious Adverse Events Committee.