An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
The FDA provides a database for reporting of adverse events called the Manufacturer and User Facility Device Experience Database (MAUDE). The data consist of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996, and is open for public view. Two private companies have also recently started providing access to analyzed adverse event information: Clarimed provides adverse event information for medical devices and AdverseEvents provides adverse event data for drugs.
An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
The terms adverse events, near misses, and medical errors are used in patient safety to refer to events where patients were harmed (or easily could have been).
2016;44:e167-e172. Becerra MB, Shirley D, Safdar N. Am J Infect Control.
Investigators in the Harvard Medical Practice Study defined an adverse event as "an injury that was caused by medical management (rather than the underlying disease) and that prolonged the hospitalization, produced a disability at the time of discharge, or both." The Institute for Healthcare Improvement uses a similar definition: "unintended physical injury resulting from or contributed to by medical care (including the absence of indicated medical treatment), that requires additional monitoring, treatment, or hospitalization, or that results in death.".
The patient had continued rectal bleeding but was reassured by the physician.
Adverse event. Any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the trial intervention. In the context.
In the context of the PROMISE trial, the circumstances listed below were NOT considered to be AEs:
Any untoward and unintended responses to the trial intervention, at any dose administered, including all AEs judged by either the reporting investigator or the sponsor as having a reasonable causal relationship to the trial intervention.
Any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the trial intervention.
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Introduction. Adverse events—“instances which indicate or may indicate that a patient has received poor quality care”—are used widely in healthcare quality.
Criterion related validity is a measure of the relation between measurements made using an instrument and an external variable (the criterion, sometimes called the gold standard) with which it is expected to correlate. The few researchers who have studied the criterion related validity of adverse event measures have mostly used some form of implicit professional assessment of the quality of care as their criterion. Although this is obviously simpler to do than identifying a separate explicit measure of the quality of care as the criterion, the acknowledged low validity and reliability of such implicit professional judgments 16, 17, 29 present some difficulties.
(a) Definitions. The following definitions of terms apply to this section: Adverse event means any untoward medical occurrence associated with the use of a drug.
(e) Disclaimer. A safety report or other information submitted by a sponsor under this part (and any release by FDA of that report or information) does not necessarily reflect a conclusion by the sponsor or FDA that the report or information constitutes an admission that the drug caused or contributed to an adverse event. A sponsor need not admit, and may deny, that the report or information submitted by the sponsor constitutes an admission that the drug caused or contributed to an adverse event.
312.32 IND safety reporting.