Medically Significant Event

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What is a Serious Adverse Event? | FDA

https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event

Report if the adverse event resulted in a substantial disruption of a person's ability to conduct normal life functions, i.e., the adverse event resulted in a significant, persistent or permanent change, impairment, damage or disruption in the patient's body function/structure, physical activities and/or quality … See more

What is medically significant in pharmacovigilance? - Quora

https://www.quora.com/What-is-medically-significant-in-pharmacovigilance

In Pharmacovigilance, Serious Adverse Events (SAE) are defined as any events which results in the following : Death Life-threatening Hospitalization (initial or prolonged) …

Inclusion/exclusion criteria for the “Important Medical …

https://www.ema.europa.eu/en/documents/other/inclusion-exclusion-criteria-important-medical-events-list-meddra_en.pdf

“important medical event” as noted below: A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose: * results in death, * is life …

Adverse Events, Near Misses, and Errors | PSNet

https://psnet.ahrq.gov/primer/adverse-events-near-misses-and-errors

A final subcategory of adverse event is the ameliorable adverse event, a term first coined in a study of postdischarge of adverse events. Ameliorable adverse events …

EMA Releases List of Medical Events for …

https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2016/8/ema-releases-list-of-medical-events-for-pharmacovigilance-monitoring

EMA also maintains a separate list of what it considers to be important medical events (IME) intended to assist with the classification …

Important Medical Events list – version 23.1 – Updates

https://allaboutpharmacovigilance.org/important-medical-events-list-version-23-1-updates/

Important Medical Events list - version 23.1 - Updates | Pharmacovigilance. The EudraVigilance Expert Working Group (EV-EWG) has coordinated the development …

EUDRAVIGILANCE IMPORTANT MEDICAL EVENT …

https://eudravigilance.ema.europa.eu/human/docs/Explanatory_note_IME_list.pdf

May 2007, the EudraVigilance Expert Working Group (EV-EWG) initiated the Idevelopment of an Important Medical Event Terms (IME) list. This IME list aims to facilitate the …

Important medical event terms list (MedDRA version …

https://www.alims.gov.rs/wp-content/uploads/2022/02/IME_list_version_241.pdf

Viral infections are an important complication of solid organ transplantation. The pathologic findings of adenovirus infection usually include a granulomatous interstitial nephritis, …

NIH Common Data Elements (CDE) Repository

https://cde.nlm.nih.gov/deView?tinyId=Su71nJ0K1WH

Severe or medically significant but not immediately life-threatening: hospitalization or prolongation of hospitalization indicated, disabling, limiting self care Activities of …

Medically Important Event Definition | Law Insider

https://www.lawinsider.com/dictionary/medically-important-event

definition. Medically Important Event. (or “ MIE ”) means any event that may jeopardise the patient or may require intervention to prevent one of the outcomes listed …

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