archetype (adl_version=1.4; uid=3bd6f60f-08ef-420c-bd69-e05aeca94796)
	openEHR-EHR-CLUSTER.ctcae.v1

concept
	[at0000]	-- Common Terminology Criteria for Adverse Events (CTCAE)
language
	original_language = <[ISO_639-1::en]>
	translations = <
		["de"] = <
			language = <[ISO_639-1::de]>
			author = <
				["name"] = <"Alina Rehberg">
				["organisation"] = <"Medizinische Hochschule Hannover">
				["email"] = <"rehberg.alina@mh-hannover.de">
			>
		>
		["sv"] = <
			language = <[ISO_639-1::sv]>
			author = <
				["name"] = <"Erik Sundvall, Vebjørn Arntzen">
				["organisation"] = <"Karolinska Institutet + Karolinska University Hospital, Region Stockholm + Linköping University, Oslo University Hospital">
				["email"] = <"erik.sundvall@regionstockholm.se, varntzen@ous-hf.no">
			>
		>
		["nb"] = <
			language = <[ISO_639-1::nb]>
			author = <
				["name"] = <"Vebjørn Arntzen, John Tore Valand">
				["organisation"] = <"Oslo University Hospital, Helse Bergen">
				["email"] = <"varntzen@ous-hf.no, john.tore.valand@helse-vest-ikt.no">
			>
		>
	>
description
	original_author = <
		["name"] = <"Heather Leslie">
		["organisation"] = <"Atomica Informatics">
		["email"] = <"heather.leslie@atomicainformatics.com">
		["date"] = <"2021-01-11">
	>
	details = <
		["de"] = <
			language = <[ISO_639-1::de]>
			purpose = <"*To provide a framework for recording any unfavourable and unintended sign, symptom or disease temporally using the CTCAE terminology.
To provide a framework for recording a CTCAE classification. (en)">
			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. (en)">
			keywords = <"ctcae", "Symptom", "Krankheit", "unerwünscht", "Ereignis">
			misuse = <"*Not to be used for recording details about adverse events outside of the CTCAE classification. (en)">
		>
		["sv"] = <
			language = <[ISO_639-1::sv]>
			purpose = <"*To provide a framework for recording any unfavourable and unintended sign, symptom or disease temporally using the CTCAE terminology.
To provide a framework for recording a CTCAE classification. (en)">
			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. (en)">
			keywords = <"CTCAE", "biverkan", "biverkningar", "tecken", "symptom", "sjukdom", "cytostatika">
			misuse = <"*Not to be used for recording details about adverse events outside of the CTCAE classification. (en)">
		>
		["nb"] = <
			language = <[ISO_639-1::nb]>
			purpose = <"Et rammeverk for å registrere CTCAE-klassifisering.">
			use = <"Bruk som et rammeverk for å registrere CTCAE-klassifisering, ved å bruke koder fra hierarkiet av termer fra MedDRA-terminologien.

Denne arketypen er tiltenkt å nøstes i CLUSTER.symptom_sign (Symptom/Sykdomstegn) eller EVALUATION.problem_diagnosis (Problem/diagnose) eller en annen klinisk relevant arketype.">
			keywords = <"ctcae", "sykdomstegn", "symptom", "sykdom", "utilsiktet", "ugunstig", "uønsket", "hendelse", "bivirkning", "toksisitet", "toxicity", "legemiddel", "kreft", "malignitet", "kjemoterapi", "stråling", "proton", "CTC", "senskade">
			misuse = <"Skal ikke brukes for å registrere uønskede hendelser utenom å klassifisere CTCAE.">
		>
		["en"] = <
			language = <[ISO_639-1::en]>
			purpose = <"To provide a framework for recording a CTCAE classification.">
			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.">
			keywords = <"ctcae", "sign", "symptom", "disease", "adverse", "event">
			misuse = <"Not to be used for recording details about adverse events outside of the CTCAE classification.">
			copyright = <"© openEHR Foundation">
		>
	>
	lifecycle_state = <"published">
	other_contributors = <"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">
	other_details = <
		["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"] = <"8F96A89D77D4F736B57D36E1D2B697F4">
		["build_uid"] = <"3136e0c7-5850-4a19-abb7-24742e3f657e">
		["revision"] = <"1.0.0">
	>

definition
	CLUSTER[at0000] matches {    -- Common Terminology Criteria for Adverse Events (CTCAE)
		items cardinality matches {1..*; unordered} matches {
			ELEMENT[at0001] occurrences matches {0..1} matches {    -- Category
				value matches {
					DV_TEXT matches {*}
				}
			}
			ELEMENT[at0002] matches {    -- Term
				value matches {
					DV_TEXT matches {*}
				}
			}
			ELEMENT[at0003] matches {    -- Grade category
				value matches {
					0|[local::at0021],
					1|[local::at0015],
					2|[local::at0016],
					3|[local::at0017],
					4|[local::at0018],
					5|[local::at0019]
				}
			}
			ELEMENT[at0020] occurrences matches {0..1} matches {    -- Grade description
				value matches {
					DV_TEXT matches {*}
				}
			}
			ELEMENT[at0009] occurrences matches {0..1} matches {    -- CTCAE version
				value matches {
					DV_TEXT matches {*}
				}
			}
		}
	}



ontology
	term_definitions = <
		["en"] = <
			items = <
				["at0000"] = <
					text = <"Common Terminology Criteria for Adverse Events (CTCAE)">
					description = <"A framework for recording the CTCAE classification for an unfavourable and unintended sign, symptom or disease.">
					comment = <"Formerly known as Common Toxicity Criteria (CTC).">
				>
				["at0001"] = <
					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.">
				>
				["at0002"] = <
					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.">
				>
				["at0003"] = <
					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.">
				>
				["at0009"] = <
					text = <"CTCAE version">
					description = <"The version of the CTCAE terminology used.">
				>
				["at0015"] = <
					text = <"Grade 1">
					description = <"Mild; OR asymptomatic or mild symptoms; OR clinical or diagnostic observations only; OR intervention not indicated.">
				>
				["at0016"] = <
					text = <"Grade 2">
					description = <"Moderate; OR minimal, local or non-invasive intervention indicated; OR limiting age-appropriate instrumental ADL.">
				>
				["at0017"] = <
					text = <"Grade 3">
					description = <"Severe or medically significant but not immediately life-threatening; OR hospitalization or prolongation of hospitalization indicated OR disabling; limiting self-care ADL.">
				>
				["at0018"] = <
					text = <"Grade 4">
					description = <"Life-threatening consequences OR urgent intervention indicated.">
				>
				["at0019"] = <
					text = <"Grade 5">
					description = <"Death related to AE.">
				>
				["at0020"] = <
					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.">
				>
				["at0021"] = <
					text = <"Grade 0">
					description = <"Absence of an adverse event or within normal limits; found only in CTC versions 1 and 2.">
				>
			>
		>
		["de"] = <
			items = <
				["at0000"] = <
					text = <"Common Terminology Criteria of Adverse Events (CTCAE)">
					description = <"*A framework for recording the CTCAE classification for an unfavourable and unintended sign, symptom or disease. (en)">
				>
				["at0001"] = <
					text = <"*Category (en)">
					description = <"*The MedDRA System Organ Class (SOC) category corresponding to the CTCAE 'Term' (LLT). (en)">
					comment = <"*This element identifies the anatomical or physiological system, aetiology or purpose. (en)">
				>
				["at0002"] = <
					text = <"Terme">
					description = <"*The name of the sign, symptom or disease observed, recorded as a MedDRA Lowest Level Term (LLT). (en)">
					comment = <"*This element can be mapped to the corresponding MedDRA code. (en)">
				>
				["at0003"] = <
					text = <"*Grade category(en)">
					description = <"*The category representing the severity of the adverse event. (en)">
					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. (en)">
				>
				["at0009"] = <
					text = <"CTCAE Version">
					description = <"Die verwendete Version der CTCAE-Terminologie.">
				>
				["at0015"] = <
					text = <"*Grad 1 (nb)">
					description = <"*Mild, ELLER asymptomatisk eller milde symptomer, ELLER kun kliniske eller diagnostiske observasjoner, ELLER ikke grunnlag for intervensjon. (nb)">
				>
				["at0016"] = <
					text = <"*Grad 2 (nb)">
					description = <"*Moderat, ELLER minimal, lokal eller indikasjon for ikke-invasiv intervensjon, ELLER begrenser alders-tilpasset ADL. (nb)">
				>
				["at0017"] = <
					text = <"*Grad 3 (nb)">
					description = <"*Alvorlig eller medisinsk betydningsfull, men ikke umiddelbart livstruende, ELLER indikasjon for sykehusinnleggelse eller forlengelse av sykehusopphold, ELLER invalidiserende, begrenset evne til egenomsorg og ADL. (nb)">
				>
				["at0018"] = <
					text = <"*Grad 4 (nb)">
					description = <"*Livstruende konsekvenser, ELLER indikasjon for øyeblikkelig intervensjon. (nb)">
				>
				["at0019"] = <
					text = <"*Grad 5 (nb)">
					description = <"*Død relatert til uønsket medisinsk hendelse. (nb)">
				>
				["at0020"] = <
					text = <"*Grade description (en)">
					description = <"*The observed term or phrase representing the severity of the  adverse event.  (en)">
					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. (en)">
				>
				["at0021"] = <
					text = <"*Grade 0 (en)">
					description = <"*An absence of an adverse event or within normal limits; found only in CTC versions 1 and 2. (en)">
				>
			>
		>
		["sv"] = <
			items = <
				["at0000"] = <
					text = <"Common Terminology Criteria for Adverse Events (CTCAE)">
					description = <"*A framework for recording the CTCAE classification for an unfavourable and unintended sign, symptom or disease. (en)">
				>
				["at0001"] = <
					text = <"*Category (en)">
					description = <"*The MedDRA System Organ Class (SOC) category corresponding to the CTCAE 'Term' (LLT). (en)">
					comment = <"*This element identifies the anatomical or physiological system, aetiology or purpose. (en)">
				>
				["at0002"] = <
					text = <"Term">
					description = <"*The name of the sign, symptom or disease observed, recorded as a MedDRA Lowest Level Term (LLT). (en)">
					comment = <"*This element can be mapped to the corresponding MedDRA code. (en)">
				>
				["at0003"] = <
					text = <"*Grade category(en)">
					description = <"*The category representing the severity of the adverse event. (en)">
					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. (en)">
				>
				["at0009"] = <
					text = <"CTCAE-version">
					description = <"Den version av CTCAE-terminologin som använts.">
				>
				["at0015"] = <
					text = <"*Grad 1 (nb)">
					description = <"*Mild, ELLER asymptomatisk eller milde symptomer, ELLER kun kliniske eller diagnostiske observasjoner, ELLER ikke grunnlag for intervensjon. (nb)">
				>
				["at0016"] = <
					text = <"*Grad 2 (nb)">
					description = <"*Moderat, ELLER minimal, lokal eller indikasjon for ikke-invasiv intervensjon, ELLER begrenser alders-tilpasset ADL. (nb)">
				>
				["at0017"] = <
					text = <"*Grad 3 (nb)">
					description = <"*Alvorlig eller medisinsk betydningsfull, men ikke umiddelbart livstruende, ELLER indikasjon for sykehusinnleggelse eller forlengelse av sykehusopphold, ELLER invalidiserende, begrenset evne til egenomsorg og ADL. (nb)">
				>
				["at0018"] = <
					text = <"*Grad 4 (nb)">
					description = <"*Livstruende konsekvenser, ELLER indikasjon for øyeblikkelig intervensjon. (nb)">
				>
				["at0019"] = <
					text = <"*Grad 5 (nb)">
					description = <"*Død relatert til uønsket medisinsk hendelse. (nb)">
				>
				["at0020"] = <
					text = <"*Grade description (en)">
					description = <"*The observed term or phrase representing the severity of the  adverse event.  (en)">
					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. (en)">
				>
				["at0021"] = <
					text = <"*Grade 0 (en)">
					description = <"*An absence of an adverse event or within normal limits; found only in CTC versions 1 and 2. (en)">
				>
			>
		>
		["nb"] = <
			items = <
				["at0000"] = <
					text = <"Common Terminology Criteria for Adverse Events (CTCAE)">
					description = <"Et rammeverk for å registrere CTCAE klassifikasjon av en uønsket hendelse, symptom eller sykdomtilstand.">
					comment = <"Tidligere kjent som Common Toxicity Criteria (CTC).">
				>
				["at0001"] = <
					text = <"Kategori">
					description = <"Kategorien innenfor MedDRA System Organ Class (SOC) som er knyttet til CTCAE Term (LTT).">
					comment = <"Dette elementet identifiserer et anatomisk eller fysiologisk system, etiologi eller formål.

">
				>
				["at0002"] = <
					text = <"Term">
					description = <"Navnet på sykdomstegnet, symptomet eller sykdommen som er observert, registrert som en MedDRA Lowest Level Term (LLT).">
					comment = <"Dette elementet kan mappes til den korresponderende MedDRA-koden.">
				>
				["at0003"] = <
					text = <"Kategori for grad">
					description = <"Kategorien som representerer alvorlighetsgraden av den uønskede hendelsen.">
					comment = <"Den kliniske beskrivelsen for hver \"Kategori for grad\" er dokumentert i den publiserte spesifikasjonen av CTCAE v5.0. Grad 0 har ikke vært i bruk siden CTCAE v2, men er tatt med for å kunne brukes for alle versjoner av CTCAE.">
				>
				["at0009"] = <
					text = <"CTCAE- versjon">
					description = <"Den versjonen av CTCAE-terminologien som er brukt.">
				>
				["at0015"] = <
					text = <"Grad 1">
					description = <"Mild, ELLER asymptomatisk eller milde symptomer, ELLER kun kliniske eller diagnostiske observasjoner, ELLER ikke grunnlag for intervensjon.">
				>
				["at0016"] = <
					text = <"Grad 2">
					description = <"Moderat, ELLER minimal, lokal eller indikasjon for ikke-invasiv intervensjon, ELLER begrenser alders-tilpasset ADL.">
				>
				["at0017"] = <
					text = <"Grad 3">
					description = <"Alvorlig eller medisinsk betydningsfull, men ikke umiddelbart livstruende, ELLER indikasjon for sykehusinnleggelse eller forlengelse av sykehusopphold, ELLER invalidiserende, begrenset evne til egenomsorg og ADL.">
				>
				["at0018"] = <
					text = <"Grad 4">
					description = <"Livstruende konsekvenser, ELLER indikasjon for øyeblikkelig intervensjon.">
				>
				["at0019"] = <
					text = <"Grad 5">
					description = <"Død relatert til uønsket medisinsk hendelse.">
				>
				["at0020"] = <
					text = <"Beskrivelse av grad">
					description = <"Termen eller frasen som representerer alvorlighetsgraden til den uønskede hendelsen.">
					comment = <"Dette elementet er en plassholder for term eller frase som tilhører en identifisert grad. I de fleste implementasjonene vil det bli utfylt via en eksterne kilde, som en CTCAE kunnskapsbase eller en annen kilde, under kjøring av dataprogrammet (run-time).">
				>
				["at0021"] = <
					text = <"Grad 0">
					description = <"Fravær av en uønsket hendelse eller innenfor normale verdier. Bare for CTC versjon 1 og 2.">
				>
			>
		>
	>