Adverse Event - CISMeF

Preferred Label : Adverse Event;

NCIt synonyms : Adverse Experience; AE;

NCIt related terms : AdverseEvent; adverse event (AE); side effects;

NCIt definition : Any unfavorable or unintended disease, sign, or symptom (including an abnormal laboratory finding) that is temporally associated with the use of a medical treatment or procedure, and that may or may not be considered related to the medical treatment or procedure. Such events can be related to the intervention, dose, route of administration, patient, or caused by an interaction with another drug(s) or procedure(s).;

Alternative definition : CDISC-GLOSS: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. an adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. NOTE: For further information, see the ICH Guideline for Clinical safety Data Management: Definitions and standards for expedited Reporting. [After ICH E2A] See also serious adverse event, serious adverse experience.; CDISC: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. NOTE: For further information, see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting. [Modified from ICH E2A] Synonyms: side effect, adverse experience. See also serious adverse event, serious adverse experience. (CDISC glossary); NCI-GLOSS: An unexpected medical problem that happens during treatment with a drug or other therapy. Adverse effects do not have to be caused by the drug or therapy, and they may be mild, moderate, or severe.; BRIDG 3.0.3: Any unfavorable and unintended sign, symptom, disease, or other medical occurrence with a temporal association with the use of a medical product, procedure or other therapy, or in conjunction with a research study, regardless of causal relationship. EXAMPLE(S): death, back pain, headache, pulmonary embolism, heart attack; BRIDG 5.3: Any unfavorable and unintended sign, symptom, disease, or other medical occurrence with a temporal association with the use of a medical product, procedure or other therapy, or in conjunction with a research study, regardless of causal relationship. EXAMPLE(S): death, back pain, headache, pulmonary embolism, heart attack OTHER NAME(S): NOTE(S): The BRIDG SCC has a GForge Tracker Issue (#31893) indicating a need to validate the requirement that every AdverseEvent be described by a SafetyReportVersion.;

Codes from synonyms : CDR0000444960;

Details

Origin ID

C41331;

UMLS CUI

C0877248;

Automatic exact mappings (from CISMeF team)
- Adverse effect, unspecified [ICD-10 Sub-category (who)]
- No adverse effect [MedDRA LLT]
- No adverse event [MedDRA Preferred Term]
- Side Effect [ICNP subject]
- adverse reaction [Blood Transfusion thesaurus concept]
- drug reactions [MedlinePlus Topic]
- side effect [Radlex concept]
- side effect [Artificial nutrition thesaurus concept]
Currated CISMeF NLP mapping
- Adverse event [LOINC component]
- Adverse event [MedDRA Preferred Term]
- Adverse event NOS [MedDRA LLT]
- Adverse reaction (disorder) [SNOMED CT concept]
- adverse effects [MeSH Qualifier]
- adverse event [Q-code]
- adverse reaction [Disease (Nov.)]
Semantic type(s)
- Pathologic Function [UMLS semantic type]
UMLS correspondences (same concept)
- Adverse event [LOINC component]
- Adverse event [MedDRA Preferred Term]
- Adverse event NOS [MedDRA LLT]
concept_is_in_subset
- ALL Authorized Value Terminology [NCIt concept]
- ALL Off Protocol Therapy/Study Table [NCIt concept]
- AML Adverse Events Table [NCIt concept]
- AML Authorized Value Terminology [NCIt concept]
- AML Off Protocol Therapy/Study Table [NCIt concept]
- AML Variable Terminology [NCIt concept]
- BRIDG Class Terminology [NCIt concept]
- BRIDG Terminology [NCIt concept]
- CDISC Glossary Terminology [NCIt concept]
- CDISC SDTM Reason for Non-Completion Terminology [NCIt concept]
- CDISC SDTM Terminology [NCIt concept]
- Clinical Data Interchange Standards Consortium Terminology [NCIt concept]
- FDA Individual Case Safety Report Terminology [NCIt concept]
- GCT Adverse Events Table [NCIt concept]
- GCT Variable Terminology [NCIt concept]
- GDC Property Terminology [NCIt concept]
- GDC Terminology [NCIt concept]
- GDC Value Terminology [NCIt concept]
- HL Adverse Events Table [NCIt concept]
- HL Authorized Value Terminology [NCIt concept]
- HL Off Protocol Therapy/Study Table [NCIt concept]
- HL Variable Terminology [NCIt concept]
- ICDC Node Terminology [NCIt concept]
- ICDC Terminology [NCIt concept]
- OS Authorized Value Terminology [NCIt concept]
- OS Off Protocol Therapy/Study Table [NCIt concept]
- Type of Event ICSR Terminology [NCIt concept]

Keyword's position in hierarchy(ies) :

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