serious adverse event

(redirected from Serious Adverse Reaction)

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 precaution is a condition that might increase the risk for a serious adverse reaction or compromise the vaccine's ability to produce immunity, according to the CDC.
Hib is one of the safest vaccines - there has not been a single report of a serious adverse reaction anywhere in the UK.
The serious adverse reaction that has been reported in clinical studies is hemorrhage (intra-abdominal, hemarthrosis, and post procedural).
Serious Adverse Reaction (SAR): Multiple definitions are possible and no single one is correct in all situations.
The investigators determined that only 2% of patients were at risk for a serious adverse reaction, but another 45% were at risk for minor adverse reactions.
PI: Intravenous: The serious adverse reaction seen during intravenous treatment in the clinical trials for PI aseptic meningitis.
Intravenous: The most serious adverse reaction seen during intravenous treatment in the clinical trials was two episodes of aseptic meningitis in one subject.
The MHRA defines serious adverse reactions as those that result in death, are immediately life-threatening, or result in the patient being admitted to hospital or permanently disabled.
Risk of Hypersensitivity, Serious Adverse Reactions, and Antibody Development in Hunter Syndrome Patients with Severe Genetic Mutations:
The candidateEbolavaccine, which GSK co-developed with theUnited StatesNational Institutes of Health, has also been given to 10 volunteers taking part in a separate trial in the United States, and so far there were no signs of any serious adverse reactions, doctors said.
The following serious adverse reactions have been most commonly reported from the post-marketing spontaneous reports: urticaria, dyspnea, pruritus, tachycardia, erythema, pyrexia, chest discomfort, chills, angioedema, back pain, arthralgia, and syncope.