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 ?
These drugs eventually acquired at least one black box warning for serious adverse drug reactions (ADRs) or were withdrawn from the market for safety reasons that were not recognized at the time of Food and Drug Administration approval, the investigators said.
We very much look forward to having a positive impact in the FDA's effort to predict serious adverse drug reactions at the individual patient level.
1 percent) experienced serious adverse drug reactions, including inhibitor formation, hemarthrosis and catheter placement complications.
Recent studies show that more than two million hospitalized patients had serious adverse drug reactions in one year," Dr.
Arthur Holden, CEO of First Genetic Trust, adds that "First Genetic Trust is proud to be working once again with GlaxoSmithKline, as a recognized leader in the field of pharmacogenetics, in advancing the field of research into serious adverse drug reactions.
Serious adverse drug reactions (ADRs) are usually so uncommon they do not become apparent or problematic until a medication is used widely in a heterogeneous population, yet ADRs are a primary reason that effective medications must be removed from the market.
NSAID use can lead to stomach ulcers and other serious complications, and is the greatest source of serious adverse drug reactions reported to the FDA.