Serious adverse event
id:
serious-adverse-event-171-7098479
title:
Serious adverse event
text:
A serious adverse event (SAE) in human drug trials is defined as any untoward medical occurrence that at any dose
- Results in death
- Is life-threatening
- Requires inpatient hospitalization or causes prolongation of existing hospitalization
- Results in persistent or significant disability/incapacity
- May have caused a congenital anomaly/birth defect
- Requires intervention to prevent permanent impairment or damage The term "life-threatening" in the definition of "serious" refers
brand slug:
wiki
category slug:
encyclopedia
description:
original url:
https://en.wikipedia.org/wiki/Serious_adverse_event
date created:
2005-07-14T19:35:02Z
date modified:
2024-09-01T06:40:56Z
main entity:
{"identifier":"Q446142","url":"https://www.wikidata.org/entity/Q446142"}
image:
fields total:
13
integrity:
14