serious adverse event

(redirected from Serious Adverse Drug Reaction)
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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 ?
A group of seven of the largest drug manufacturers has formed a consortium to study the genetics of serious adverse drug reactions.
The most commonly used national surveillance system for ADEs, the FDA Adverse Event Reporting System (AERS), is a passive surveillance system estimated to capture 1%-38% of serious adverse drug reactions and influenced by such factors as length of time the drug has been on the market and media attention (5).
Serious adverse drug reactions were noted after marketing in more than 10% of 548 drugs approved between 1975 and 1999, according to Dr.
The company will also participate in several NCTR-led projects including the multi-year PADRE project (MAQC-IV), which is focusing on the modelling of drug-protein interactions to identify new genetic variations that may lead to serious adverse drug reactions.
This figure compares favorably with the FDA's Adverse Event Reporting System, a passive surveillance system estimated to capture 1%-38% of serious adverse drug reactions. It is a system which is influenced by factors such as the length of time the drug has been on the market and media attention, the CDC noted.
'Rare serious adverse drug reactions, including serious liver reactions, are described in the product information.
hospitals estimated that approximately 2.2 million serious adverse drug reactions and 106,000 fatal reactions were recorded in 1994.