Medically Significant Serious Adverse Event

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 of life. See more

CFR - Code of Federal Regulations Title 21 - Food and …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=312.32

Serious adverse event or serious suspected adverse reaction. An adverse event or suspected adverse reaction is considered "serious" if, in the view of either the …

NIA Adverse Event and Serious Adverse Event …

https://www.nia.nih.gov/sites/default/files/2018-09/nia-ae-and-sae-guidelines-2018.pdf

Adverse Event (AE): Any untoward or unfavorable medical occurrence in a human study participant, including any abnormal sign (e.g. abnormal physical exam or laboratory …

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) …

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

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

They attributed the advanced disease to substandard medical care. The event was considered adverse and due to negligence." A final subcategory of adverse event is …

Serious Adverse Events | Research - University of Virginia

https://research.virginia.edu/irb-hsr/serious-adverse-events

A serious adverse event will be considered any undesirable sign, symptom, or medical condition with one or more of the following outcomes: is fatal, is life-threatening, requires …

16. Seriousness assessment of adverse event reports

https://allaboutpharmacovigilance.org/16-seriousness-assessment-of-adverse-event-reports/

Seriousness assessment of adverse event reports | Pharmacovigilance. Correct seriousness assessment is critical in case processing as it impacts regulatory …

Reported rates of all-cause serious adverse events …

https://pubmed.ncbi.nlm.nih.gov/36800368/

Reported rates of all-cause serious adverse events following immunization with BNT-162b in 5-17-year-old children in the United States Reported rates of all-cause …