Serious adverse event

id: serious-adverse-event-212-982746
title: Serious adverse event
text: In pharmaceuticals, serious adverse event (SAE) is defined as any untoward medical occurrence during a human drug trial 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 definiti
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: 2024-09-12T02:32:22Z
main entity: {"identifier":"Q446142","url":"https://www.wikidata.org/entity/Q446142"}
image:
fields total: 13
integrity: 14

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