Serious Adverse Drug Reaction

Preferred Label : Serious Adverse Drug Reaction;

NCIt synonyms : Serious ADR;

NCIt definition : A noxious and unintended response to a medicinal product occurring at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, or results in a congenital anomaly/birth defect.;

Alternative definition : CDISC-GLOSS: Adverse drug reaction that at any dose of the drug: 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: FDA 21 CFR 310.305 defines an adverse drug experience to include any adverse event, whether or not considered to be drug-related. CDISC recognizes that current usage incorporates the concept of causality. [1. WHO Technical Report 498(1972); 2. After ICH E2A, B] See ICH E6 definition and serious and severe definitions.;

NCI Metathesaurus CUI : CL540603;

Details

Origin ID

C142685;

UMLS CUI

C4684772;

Semantic type(s)
- Pathologic Function [UMLS semantic type]
concept_is_in_subset
- CDISC Glossary Terminology [NCIt concept]
- Clinical Data Interchange Standards Consortium Terminology [NCIt concept]

Keyword's position in hierarchy(ies) :

Main resources

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