Other Serious Important Medical Events

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Other Serious (Important Medical Events)

https://nett.umich.edu/sites/default/files/docs/9_shine_mop_version_3_28jan2013-4.pdf

Other Serious (Important Medical Events): Report when the event does not fit the other outcomes, but the event may jeopardize the patient and may require medical or surgical intervention (treatment) to prevent one of the other outcomes. Examples include allergic …

What is a Serious Adverse Event? | FDA

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

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

considered a serious event, although anaemia and blood transfusion are not included in the IME list. Criteria for MedDRA terms on the IME list: 1. Cardiovascular conditions leading …

EMA list of important medical events | SpringerLink

https://link.springer.com/article/10.1007/s40278-016-20780-z

A list of designated important medical events has been developed and provides standardised terms for medical conditions that are serious and usually drug …

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 …

POST-APPROVAL SAFETY DATA MANAGEMENT: …

https://www.fda.gov/media/71228/download

An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have to have a causal relationship with …

European Medicines Agency

https://www.ema.europa.eu/en/documents/other/meddra-important-medical-event-terms-list-version-250_en.xlsx

PT Head crushing injury was added in V25.0 and meets the ICH definition of seriousness and of an “important medical event”: "A serious adverse event (experience) or reaction is …

What is a major medical event? - Studybuff

https://studybuff.com/what-is-a-major-medical-event/

Important Medical Event means an Adverse Event that may not be immediately life-threatening or result in death or hospitalisation but may jeopardise the subject or require …

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, …

Important Medical Events list – version 23.1 – Updates

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

Unqualified (e.g., PT Cystitis, PT Rhinitis) and nonspecific inflammations (e.g., PT Connective tissue inflammation of non-vital organs and tissues, are excluded. …

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