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  2. Adverse Events - StatPearls - NCBI Bookshelf

    www.ncbi.nlm.nih.gov/books/NBK558963

    The term adverse event is a broad term that can encompass any negative effect. However, a sentinel event is a term used when the result is serious harm or death. Healthcare providers must report adverse events that result in serious harm or death to the patient as sentinel events.

  3. Adverse Events | HHS-OIG - Office of Inspector General

    oig.hhs.gov/.../featured-topics/adverse-events

    Adverse Event - An event in which care resulted in an undesirable clinical outcome-an outcome not caused by underlying disease-that prolonged the patient stay, caused permanent patient harm, required life-saving intervention, or contributed to death.

  4. What is a Serious Adverse Event? | FDA - U.S. Food and Drug ...

    www.fda.gov/.../what-serious-adverse-event

    An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to FDA when the...

  5. Adverse event - Wikipedia

    en.wikipedia.org/wiki/Adverse_event

    In pharmaceuticals, 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.

  6. Adverse event. Any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the trial intervention. In the context of the PROMISE trial, an AE was considered to be:

  7. Adverse Events, Near Misses, and Errors | PSNet

    psnet.ahrq.gov/primer/adverse-events-near-misses...

    In summary, adverse events refer to harm from medical care rather than an underlying disease. Important subcategories of adverse events include: Preventable adverse events: those that occurred due to error or failure to apply an accepted strategy for prevention;

  8. Common Terminology Criteria for Adverse Events (CTCAE) - Cancer

    ctep.cancer.gov/protocoldevelopment/electronic...

    Definition: A disorder characterized by the inability of the heart to pump blood at an adequate volume to meet tissue metabolic requirements, or, the ability to do so only at an elevation in the filling pressure.