ARCHETYPE Common Terminology Criteria for Adverse Events (CTCAE) (openEHR-EHR-CLUSTER.ctcae.v1)

ARCHETYPE IDopenEHR-EHR-CLUSTER.ctcae.v1
ConceptCommon Terminology Criteria for Adverse Events (CTCAE)
DescriptionA framework for recording the CTCAE classification for an unfavourable and unintended sign, symptom or disease.
UseUse to provide a framework for recording a CTCAE classification, using terms from appropriate MedDRA terminology hierarchies. This archetype is intended to be nested in the 'Specific details' SLOT within either the EVALUATION.problem_diagnosis or CLUSTER.symptom_sign archetypes, or other clinically relevant archetypes.
MisuseNot to be used for recording details about adverse events outside of the CTCAE classification.
PurposeTo provide a framework for recording a CTCAE classification.
ReferencesNIH... Turning Discovery Into Health [Internet]. Maryland: National Institute of Health. Common Terminology Criteria for Adverse Events (CTCAE); last updated 2021 Sep 04 [cited 2023 Feb 22]. Available from: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm.
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, references=NIH... Turning Discovery Into Health [Internet]. Maryland: National Institute of Health. Common Terminology Criteria for Adverse Events (CTCAE); last updated 2021 Sep 04 [cited 2023 Feb 22]. Available from: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm., original_namespace=org.openehr, original_publisher=openEHR Foundation, custodian_namespace=org.openehr, MD5-CAM-1.0.1=E39F106284172E536F5DDD79A62CA873, build_uid=4178054c-28f8-4191-a60c-173b5522e0c2, revision=1.0.2}
Keywordsctcae, sign, symptom, disease, adverse, event
Lifecyclepublished
UIDe43f7e6f-62a8-4d94-b6ce-df1c60fc96b6
Language useden
Citeable Identifier1246.145.1477
Revision Number1.0.2
AllArchetype [runtimeNameConstraintForConceptName=null, archetypeConceptBinding=null, archetypeConceptDescription=A framework for recording the CTCAE classification for an unfavourable and unintended sign, symptom or disease., archetypeConceptComment=Formerly known as Common Toxicity Criteria (CTC)., otherContributors=Marit Alice Venheim, Helse Vest IKT, Norway (Nasjonal IKT redaktør)
Vebjørn Arntzen, Oslo University Hospital, Norway (openEHR Editor)
Silje Ljosland Bakke, Helse Vest IKT AS, Norway (openEHR Editor)
Aleocidio Balzanelo, UHG Brasil, Brazil
Ivar Berge, Oslo Universitetssykehus, Norway
SB Bhattacharyya, Bhattacharyyas Clinical Records Research & Informatics LLP, India
Adam Bouras, CDC/OGHA, United States
Randi Brendberg, Helse Nord RHF, Norway
Laila Bruun, Oslo universitetssykehus HF, Norway
Ian Bull, ACT Health, Australia
giovanni delussu, crs4, Italy
Rosane Gotardo, Systema Ltda., Brazil
Elin Hallan Naderi, OUS, Norway
Amanda Herbrand, University Hospital Basel, Switzerland
Joost Holslag, Nedap, Netherlands
Evelyn Hovenga, EJSH Consulting, Australia
Mikkel Johan Gaup Grønmo, Regional forvaltning EPJ, Helse Nord, Norway (Nasjonal IKT redaktør)
Shinji Kobayashi, NPO openEHR Japan, Japan (openEHR Editor)
Kanika Kuwelker, Helse Vest IKT, Norway (Nasjonal IKT redaktør)
Jörgen Kuylenstierna, eWeave AB, Sweden
Tomi Laptoš, Marand, Slovenia
Liv Laugen, Oslo universitetssykehus, Norway (Nasjonal IKT redaktør)
Heather Leslie, Atomica Informatics, Australia (openEHR Editor)
Nina Louise Jebsen, Haukeland Universitetssykehus, Norway
Hanne Marte Bårholm, Helse Vest IKT, Norway (Nasjonal IKT redaktør)
Cecilie Moe, Oslo Universitessykehus, Norway
Bjoern Naess, DIPS ASA, Norway
Arunakiry Natarajan, medondo, Germany
Terje Nordberg, Helse Bergen, Norway
Mikael Nyström, Cambio Healthcare Systems AB, Sweden
Bjørn Næss, DIPS ASA, Norway
Helge Pettersen, Helse Bergen, Norway
Ragnhild Schultz, OUS, Norway
Natalia Strauch, Medizinische Hochschule Hannover, Germany
Norwegian Review Summary, Norwegian Public Hospitals, Norway
Erik Sundvall, Sweden
Venkatesh Thoppae, Dedalus, United Kingdom
Anders Thurin, VGR, Sweden
John Tore Valand, Helse Bergen, Norway (openEHR Editor)
Ina Wille, Helse-Vest RHF, Norway
Neill Yeoman, The Christie NHS Foundation Trust, United Kingdom, originalLanguage=en, translators=
  • German: Alina Rehberg, Natalia Strauch, Medizinische Hochschule Hannover, rehberg.alina@mh-hannover.de, Strauch.Natalia@mh-hannover.de
  • Swedish: Erik Sundvall, Vebjørn Arntzen, Karolinska Institutet + Karolinska University Hospital, Region Stockholm + Linköping University, Oslo University Hospital, erik.sundvall@regionstockholm.se, varntzen@ous-hf.no
  • Norwegian Bokmål: Vebjørn Arntzen, John Tore Valand, Oslo University Hospital, Helse Bergen, varntzen@ous-hf.no, john.tore.valand@helse-vest-ikt.no
, subjectOfData=unconstrained, archetypeTranslationTree=null, topLevelToAshis={state=[], content=[], source=[], events=[], capabilities=[], details=[], protocol=[], provider=[], data=[], activities=[], contacts=[], identities=[], relationships=[], description=[], ism_transition=[], target=[], credentials=[], items=[ResourceSimplifiedHierarchyItem [path=/items[at0001], code=at0001, itemType=ELEMENT, level=1, text=Category, description=The MedDRA System Organ Class (SOC) category corresponding to the CTCAE 'Term' (LLT)., comment=This element identifies the anatomical or physiological system, aetiology or purpose., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, 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, recorded as a MedDRA Lowest Level Term (LLT)., comment=This element can be mapped to the corresponding MedDRA 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 category, description=The category representing the severity of the adverse event., comment=The clinical descriptions for each 'Grade category' are documented in the published CTCAE v5.0 specification. Grade 0 has not been in use since CTCAE v2 but allows for the use of all versions of CTCAE., uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=C_DV_ORDINAL, bindings=null, values=0: Grade 0 [Absence of an adverse event or within normal limits; found only in CTC versions 1 and 2.]
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[at0020], code=at0020, itemType=ELEMENT, level=1, text=Grade description, description=The term or phrase representing the severity of the adverse event., comment=This element is a placeholder for the term or phrase associated with an identified grade. In most implementations it will be sourced from an external CTCAE knowledge base or resource at run-time., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, 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]], context=[], other_participations=[]}, 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=Category, description=The MedDRA System Organ Class (SOC) category corresponding to the CTCAE 'Term' (LLT)., comment=This element identifies the anatomical or physiological system, aetiology or purpose., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, 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, recorded as a MedDRA Lowest Level Term (LLT)., comment=This element can be mapped to the corresponding MedDRA 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 category, description=The category representing the severity of the adverse event., comment=The clinical descriptions for each 'Grade category' are documented in the published CTCAE v5.0 specification. Grade 0 has not been in use since CTCAE v2 but allows for the use of all versions of CTCAE., uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=C_DV_ORDINAL, bindings=null, values=0: Grade 0 [Absence of an adverse event or within normal limits; found only in CTC versions 1 and 2.]
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[at0020], code=at0020, itemType=ELEMENT, level=1, text=Grade description, description=The term or phrase representing the severity of the adverse event., comment=This element is a placeholder for the term or phrase associated with an identified grade. In most implementations it will be sourced from an external CTCAE knowledge base or resource at run-time., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, 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]], minIndents={}, termBindingRetrievalErrorMessage=null]