ARCHETYPE Common Terminology Criteria for Adverse Events (CTCAE) (openEHR-EHR-CLUSTER.ctcae.v0)

ARCHETYPE IDopenEHR-EHR-CLUSTER.ctcae.v0
ConceptCommon Terminology Criteria for Adverse Events (CTCAE)
DescriptionA framework for recording any unfavourable and unintended sign, symptom or disease temporally using the CTCAE terminology.
UseA framework for recording any unfavourable and unintended sign, symptom or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure using the CTCAE terminology. This archetype is intended to be used within the context of the CLUSTER.symptom_sign or EVALUATION.problem_diagnosis archetype or other clinically relevant archetypes. CTCAE is intended to be populated using MedDRA terms only.
PurposeTo provide a framework for recording any unfavourable and unintended sign, symptom or disease temporally using the CTCAE terminology.
References
Copyright© openEHR Foundation
AuthorsAuthor name: Heather Leslie
Organisation: Atomica Informatics
Email: heather.leslie@atomicainformatics.com
Date originally authored: 2021-01-11
Other Details LanguageAuthor name: Heather Leslie
Organisation: Atomica Informatics
Email: heather.leslie@atomicainformatics.com
Date originally authored: 2021-01-11
OtherDetails Language Independent{licence=This work is licensed under the Creative Commons Attribution-ShareAlike 4.0 International License. To view a copy of this license, visit http://creativecommons.org/licenses/by-sa/4.0/., custodian_organisation=openEHR Foundation, original_namespace=org.openehr, original_publisher=openEHR Foundation, custodian_namespace=org.openehr, MD5-CAM-1.0.1=CF078811D7784821446C78647F85B7E7, build_uid=3b2525e9-5237-4e23-9e52-7b389fd9ca8e, revision=0.0.1-alpha}
Keywordsctcae, sign, symptom, disease, adverse, event
Lifecyclein_development
UID5ab05865-6d45-4474-9cae-daa451ba8bba
Language useden
Citeable Identifier1246.145.1477
Revision Number0.0.1-alpha
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, subjectOfData=unconstrained, archetypeTranslationTree=null, topLevelToAshis={target=[], events=[], ism_transition=[], source=[], items=[ResourceSimplifiedHierarchyItem [path=/items[at0001], code=at0001, itemType=ELEMENT, level=1, text=System Organ Class (SOC), description=The category of the 'Term' in the MedDRA hierarchy., comment=Identified as a MedDRA primary class - representing an anatomical or physiological system, aetiology or purpose., uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0002], code=at0002, itemType=ELEMENT, level=1, text=Term, description=The name of the sign, symptom or disease observed., comment=Identified as a MEDRAterm and corresponding code., uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0003], code=at0003, itemType=ELEMENT, level=1, text=Grade, description=The severity of the Adverse event., comment=For each Grade, non-specific comments provide some general guidance about the severity for each grade and are represented within square brackets []. In practice, each grade will be represented by a specific clinical description, appropriate for the selected term and will likely be sourced from an external knowledgebase or resource., uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=C_DV_ORDINAL, bindings=null, values=1: Grade 1 [[Mild; OR asymptomatic or mild symptoms; OR clinical or diagnostic observations only; OR intervention not indicated.]]
2: Grade 2 [[Moderate; OR minimal, local or non-invasive intervention indicated; OR limiting age-appropriate instrumental ADL.]]
3: Grade 3 [[Severe or medically significant but not immediately life-threatening; OR hospitalization or prolongation of hospitalization indicated OR disabling; limiting self-care ADL.]]
4: Grade 4 [[Life-threatening consequences OR urgent intervention indicated.]]
5: Grade 5 [[Death related to AE.]]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0009], code=at0009, itemType=ELEMENT, level=1, text=CTCAE version, description=The version of the CTCAE terminology used., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null]], content=[], protocol=[], details=[], activities=[], other_participations=[], relationships=[], credentials=[], state=[], identities=[], context=[], description=[], capabilities=[], contacts=[], provider=[], data=[]}, topLevelItems={items=ResourceSimplifiedHierarchyItem [path=ROOT_/, code=at0000, itemType=CLUSTER, level=0, text=null, description=null, comment=null, uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=null, extendedValues=null]}, addHierarchyItemsTo=items, currentHierarchyItemsForAdding=[ResourceSimplifiedHierarchyItem [path=/items[at0001], code=at0001, itemType=ELEMENT, level=1, text=System Organ Class (SOC), description=The category of the 'Term' in the MedDRA hierarchy., comment=Identified as a MedDRA primary class - representing an anatomical or physiological system, aetiology or purpose., uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0002], code=at0002, itemType=ELEMENT, level=1, text=Term, description=The name of the sign, symptom or disease observed., comment=Identified as a MEDRAterm and corresponding code., uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0003], code=at0003, itemType=ELEMENT, level=1, text=Grade, description=The severity of the Adverse event., comment=For each Grade, non-specific comments provide some general guidance about the severity for each grade and are represented within square brackets []. In practice, each grade will be represented by a specific clinical description, appropriate for the selected term and will likely be sourced from an external knowledgebase or resource., uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=C_DV_ORDINAL, bindings=null, values=1: Grade 1 [[Mild; OR asymptomatic or mild symptoms; OR clinical or diagnostic observations only; OR intervention not indicated.]]
2: Grade 2 [[Moderate; OR minimal, local or non-invasive intervention indicated; OR limiting age-appropriate instrumental ADL.]]
3: Grade 3 [[Severe or medically significant but not immediately life-threatening; OR hospitalization or prolongation of hospitalization indicated OR disabling; limiting self-care ADL.]]
4: Grade 4 [[Life-threatening consequences OR urgent intervention indicated.]]
5: Grade 5 [[Death related to AE.]]
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