Serious adverse event information

A serious adverse event (SAE) in human drug trials is defined as any untoward medical occurrence that at any dose Results in death Is life-threatening...

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

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

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...

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

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

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

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

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

The Vaccine Adverse Event Reporting System (VAERS) is a United States program for vaccine safety, co-managed by the U.S. Centers for Disease Control and...

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

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...

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...

serious adverse events have been observed with varying degrees of evidence for causation. Fluoroquinolones can increase the rate of rare but serious tears...

inconvenient three-times daily frequency and is associated with serious adverse events. For these reasons it is now rarely used to treat human immunodeficiency...

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

hallucinations are very rarely reported. Priapism is a very rare adverse event that can be potentially serious. U.S. Food and Drug Administration-commissioned studies...

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

International Society of Pharmacovigilance Medication Pharmacovigilance Serious adverse event Uppsala Monitoring Centre Yellow Card Scheme CIOMS Working Group...

patterned dielectric mask deposited on a semiconductor substrate Serious adverse event, in a clinical trial Simultaneous Authentication of Equals, a password...

appear to increase risk of serious adverse events, which confirms the safety of oral naltrexone. Mortality or serious adverse events due to rebound toxicity...

nephropathy is a rare, serious adverse event that has been associated with the use of OSPs [oral sodium phosphates]. The occurrence of these events was previously...

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

other ephedra-containing supplements were linked to thousands of serious adverse events, including deaths, which caused the U.S. Food and Drug Administration...

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

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

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...

and alerts the PI of any serious adverse events that occur during the study. An adverse event is described as "any adverse change in health or "side-effect"...

patient adverse drug experience it learns of. They must report unexpected serious and fatal adverse drug events within 15 days, and other events on a quarterly...