ARCHETYPE ID | openEHR-EHR-CLUSTER.ctcae.v1 |
Concept | Common Terminology Criteria for Adverse Events (CTCAE) |
Description | A framework for recording the CTCAE classification for an unfavourable and unintended sign, symptom or disease. |
Use | Use 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. |
Misuse | Not to be used for recording details about adverse events outside of the CTCAE classification. |
Purpose | To provide a framework for recording a CTCAE classification. |
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. |
Copyright | © openEHR Foundation |
Authors | Author name: Heather Leslie Organisation: Atomica Informatics Email: heather.leslie@atomicainformatics.com Date originally authored: 2021-01-11 |
Other Details Language | Author 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=A7617F434767BA4FB95565EE2C02CEE5, build_uid=5d747e99-974f-462c-a92c-dd765c48c18f, revision=1.0.3} |
Keywords | ctcae, sign, symptom, disease, adverse, event |
Lifecycle | published |
UID | e43f7e6f-62a8-4d94-b6ce-df1c60fc96b6 |
Language used | en |
Citeable Identifier | 1246.145.1477 |
Revision Number | 1.0.3 |
All | Archetype [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=
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]], content=[], description=[], contacts=[], state=[], events=[], provider=[], identities=[], protocol=[]}, 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] |