In drug development, serious adverse event (SAE) is defined as any untoward medical occurrence during a human drug trial that at any dose Results in death...

local ethics committee. Adverse events categorized as "serious" (results in death, illness requiring hospitalization, events deemed life-threatening,...

pharmacovigilance that are used to distinguish a serious adverse event from a non-serious one. An adverse event is considered serious if it meets one or more of the following...

clinical trials, a distinction is made between an adverse event and a serious adverse event. Generally, any event which causes death, permanent damage, birth...

drug was underway in Rennes, France, in January 2016, in which serious adverse events occurred affecting five participants, including the death of one...

measure of the intensity of the adverse event in question. The terms "severe" and "serious", when applied to adverse events, are technically very different...

percentage of treated patients experiencing one or more serious adverse events. Serious adverse events are defined by the US Food and Drug Administration as...

decade. The most frequently reported adverse events were pneumothorax and infections. Since serious adverse events continue to be reported, it is recommended...

160 patients in two phase II trials. Across both trials, the most common adverse reactions (≥20%), regardless of causality, were chemotherapy-induced peripheral...

have been reported but are infrequent in trials. Other serious but rare serious adverse events include Fournier's gangrene, a severe skin infection of...

ceftriaxone in 712 children with community-acquired pneumonia, serious adverse events were experienced by 6% of those treated with levofloxacin and 4%...

A vaccine adverse event (VAE), sometimes referred to as a vaccine injury, is an adverse event believed to have been caused by vaccination. The World Health...

treatment. According to the Leapfrog Group never events are defined as "adverse events that are serious, largely preventable, and of concern to both the...

with a number of serious adverse events as well as a large number of non-serious adverse events in children" "Concerning adverse events associated with...

Propyphenazone (known as isopropylantipyrine in Japan) is a derivative of phenazone with similar analgesic and antipyretic effects. Originally patented...

collects adverse events reported during the conduct of the clinical trial however there is a separate process which ensures that serious adverse events are...

pruritus), in 14 out of 42 patients. Three patients experienced a serious adverse event. Two patients had a severe allergic reaction (severe hives and a...

2008, at the age of 52. A collection of Farber's AIDS writings, Serious Adverse Events: An Uncensored History of AIDS, was published in 2006. Interviewed...

Thirty six people had serious adverse events, including anaphylaxis and febrile convulsions. The rate of serious adverse events is one in 200,000 doses...

tentative evidence that it may cause non-serious adverse events in children, but found no increase in serious adverse events. The symptoms of a moderate acute...

the FDA between 2013 and 2014 of "Young Living customers claiming serious adverse event reactions to the products". The FDA concluded the cause of one case...

reducing payment for "never events", and will recognize hospitals that agree to certain steps when a serious avoidable adverse event occurs in the facility...

disease (VAERD), or simply enhanced respiratory disease (ERD), is an adverse event where an exacerbated course of respiratory disease occurs with higher...

of serious adverse events have occurred, resulting from spinal manipulation therapy of the lumbopelvic region. Estimates for serious adverse events vary...

2018 meta-analysis was unable to determine whether an increase serious adverse events reported in the previous meta-analysis on regular salmeterol alone...

with horse riding (1 serious adverse event every ~350 exposures) were compared to those of taking ecstasy (1 serious adverse event every ~10,000 exposures)...

grade 3 or 4 serious adverse events. Palliative care, a specialized medical care focused on the symptoms, pain, and stress of a serious illness, is recommended...

instances that adverse effects occurred but in the same frequency for the placebo and the experimental groups. Four serious adverse events occurred in the...

from the underlying condition or from the treatment itself.) Serious adverse event Adverse drug reaction Biosafety Emily's Law Fatal Care: Survive in the...

with difficult-to-manage type 2 diabetes. Despite a handful of serious adverse events such as gastrointestinal bleeding, abdominal pain, and device migration...