Serious Adverse Event

Preferred Label : Serious Adverse Event;

NCIt synonyms : SAE;

NCIt related terms : serious adverse event (SAE);

NCIt definition : Any expected or unexpected adverse event, related or unrelated to the intervention, occurring at any agent dose, any phase of product or procedure testing, that results in any of the following outcomes: death, a life-threatening adverse event, requires inpatient hospitalization (not required as part of the treatment) or prolongation of existing hospitalization, a persistent or significant disability or incapacity, or cancer, or a congenital anomaly or birth defect. Important medical events that may not result in the listed outcomes may be considered as serious when, based upon appropriate medical judgment, they represent significant hazards or potentially serious harm to the research subject or others and may require medical intervention to prevent one of the outcomes listed in this definition.;

Alternative definition : CDISC-GLOSS: Adverse event that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, or is a congenital anomaly/ birth defect. NOTE: For further information, see the ICH Guideline for Clinical safety Data Management: Definitions and standards for expedited Reporting. [After ICH E2A, B] Compare to serious adverse drug reaction.; CDISC: Adverse event that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, or is a congenital anomaly/ birth defect. NOTE: For further information, see the ICH Guideline for Clinical safety Data Management: Definitions and standards for expedited Reporting. [After ICH E2A, ICH E2B]; MRCT-Ctr: A health issue that happens during a study, and can lead to hospital care, lasting medical problems, life-threatening conditions, or death. (https://mrctcenter.org/glossaryterm/serious-adverse-event-sae/);

Origin ID

C41335;

UMLS CUI

C1519255;

Automatic exact mappings (from CISMeF team)
- endocrine disruptors [MeSH Descriptor]
- serious adverse event [Blood Transfusion thesaurus concept]
- stimulated acoustic emission [Radlex concept]
False automatic mappings
- SUMO activating enzyme complex [GO term]
Semantic type(s)
- Finding [UMLS semantic type]
concept_is_in_subset
- CDISC Glossary Terminology [NCIt concept]
- CDISC MRCT Center Clinical Research Glossary [NCIt concept]
- CDISC SDTM Reason for Non-Completion Terminology [NCIt concept]
- CDISC SDTM Terminology [NCIt concept]
- Clinical Data Interchange Standards Consortium Terminology [NCIt concept]

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