Norwegian openEHR Repository
Name
Adverse reaction event
Description
Information about a specific adverse reaction event caused by exposure to a specific substance.
Purpose
To record information about a specific adverse reaction event caused by exposure to a specific substance.
Use
Use to record information about a specific adverse reaction event caused by exposure to a specific substance. The substance may be recorded in the 'Specific substance' element in this archetype, or in an appropriate element in the parent archetype in which this archetype is nested.

This archetype is designed to be nested within the EVALUATION.adverse_reaction_risk or the OBSERVATION.adverse_reaction_monitoring archetypes, to record details about a specific reaction event, but it could also be nested within other archetypes where clinically appropriate.

The scope of this archetype has deliberately focused on identifying a pragmatic data set that are used in most clinical systems or will be suitable for most common clinical scenarios; however, it permits extension of the model when additional detail is required, using the 'Reaction details', 'Exposure details', and 'Reporting details' slots. An extension may be required if a specialist allergist or immunologist needed to record a more detailed assessment as part of a report to regulatory bodies or within the context of a clinical trial.
Misuse
Not to be used to record adverse events, including failures of clinical process, interventions or products. For example: abnormal use or mistakes/errors made in maladministration of an agent or substance; incorrect dosage; mislabelling; harm or injury caused by an intervention or procedure; overdose/poisoning etc. Use a specific archetype for this purpose.
References
Derived from: Adverse reaction risk, Published archetype [Internet]. openEHR Foundation, openEHR Clinical Knowledge Manager [cited: 2021-10-04]. Available from: https://ckm.openehr.org/ckm/archetypes/1013.1.1713
Archetype Id
openEHR-EHR-CLUSTER.adverse_reaction_event.v1
Copyright
© openEHR Foundation
Licencing
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/.
Original Author
Silje Ljosland Bakke
Helse Vest IKT AS
Date Originally Authored
2021-09-17
Language Details
Norwegian Bokmal
Silje Ljosland Bakke
Helse Vest IKT AS
Name Card Type Description
Specific substance
0..1 DV_TEXT The substance considered to be responsible for the specific adverse reaction event.
Comment
For example: 'Amoxycillin'. Only an individual substance is a valid entry in 'Specific substance'. A substance may be a compound of simpler substances, for example a medicinal product. If the 'Substance' recorded in the archetype in which this archetype is nested is an individual substance and not a substance class, then it may be duplicated in this data element, or this element may be redundant. It is strongly recommended that 'Specific substance' be coded with a terminology, for example: RxNorm, SNOMED CT, DM+D, NDFRT, ICD-9, ICD-10, UNI, ATC or CPT.
Certainty
0..1
CHOICE OF
DV_CODED_TEXT
DV_TEXT
The degree of clinical certainty that the 'Manifestation' in this reaction event was caused by exposure to the identified 'Specific substance'.
Comment
The free text data type will allow for local variation by enabling other value sets to be applied to this data element in a template - in this situation it is recommended that values should be coded using a terminology.
Constraint for DV_CODED_TEXT
  • Unconfirmed
    [It has not been objectively verified that the 'Manifestation' in this reaction event was caused by exposure to the identified 'Substance'.]
  • Confirmed
    [It has been objectively verified that the 'Manifestation' in this reaction event was caused by exposure to the identified 'Substance'. This may include clinical evidence by testing, re-challenge or observation.]
  • Refuted
    [It has been disputed or disproven that the 'Manifestation' in this reaction event was caused by exposure to the identified 'Substance', with a sufficient level of clinical certainty to justify invalidating the assertion. This may include clinical evidence by testing, re-challenge or observation.]
Manifestation
0..* DV_TEXT Clinical symptoms and/or signs that are observed or associated with the adverse reaction.
Comment
Manifestation can be expressed as a single word, phrase or brief description. For example: nausea, rash. 'No reaction' may be appropriate where a previous reaction has been noted but the reaction did not re-occur after further exposure. It is preferable that 'Manifestation' should be coded with a terminology, where possible. The values entered here may be used to display on an application screen as part of a list of adverse reactions.
Reaction description
0..1 DV_TEXT Narrative description about the adverse reaction as a whole, including details of the manifestation if required.
Onset of reaction
0..1 DV_DATE_TIME The date and/or time of the onset of the reaction.
Duration of reaction
0..1 DV_DURATION The total amount of time that the manifestation of the adverse reaction persisted.
DV_DURATION
Severity of reaction
0..1
CHOICE OF
DV_CODED_TEXT
DV_TEXT
Clinical assessment of the severity of the reaction event as a whole, potentially considering multiple different manifestations.
Comment
It is acknowledged that this assessment is very subjective. There may be some some specific practice domains where objective scales have been applied. Objective scales can be included in this model using the 'Reaction details' Cluster.
Constraint for DV_CODED_TEXT
  • Mild
    [Causes mild physiological effects.]
  • Moderate
    [Causes moderate physiological effects.]
  • Severe
    [Causes severe physiological effects.]
Reaction details
0..* Slot (Cluster) Additional details about the adverse reaction.
Comment
May include structured detail about symptoms; the anatomical location of the manifestation; grading, classification or formal severity assessments such as Common Terminology Criteria for Adverse Events; or a media representation.
Slot
Slot
Initial exposure
0..1 DV_DATE_TIME The date and/or time of the first exposure to the Substance for this Reaction Event.
Comment
Exposure can be more complicated by more than one exposure events leading to a reaction. Further details about the nature of the exposure can be provided by use of additional archetypes in the 'Exposure details' SLOT or as text in the 'Exposure description'.
Duration of exposure
0..1 DV_DURATION The total amount of time the individual was exposed to the identified 'Specific substance'.
DV_DURATION
Route of exposure
0..1 DV_TEXT The route by which the subject was exposed to the identified 'Specific substance'.
Comment
Coding of the Route of Exposure with a terminology should be used wherever possible.
Exposure description
0..1 DV_TEXT Narrative description about the exposure to the identified 'Specific substance'.
Exposure details
0..* Slot (Cluster) Additional details about exposure to the 'Specific substance'.
Slot
Slot
Clinical management description
0..1 DV_TEXT Narrative description about the clinical management provided.
Clinical management details
0..* Slot (Cluster) Additional structured details about clinical management for this reaction event.
Slot
Slot
Reporting details
0..* Slot (Cluster) Additional structured details required for reporting to regulatory bodies.
Slot
Slot
Information source
0..* Slot (Cluster) Details about the provenance of the information.
Comment
This SLOT is intended to provide details about the source of information for this particular 'Reaction event'.
Slot
Slot
Supporting clinical record information
0..* DV_EHR_URI Link to further information about the presentation and findings that exist elsewhere in the health record, including allergy test reports.
Comment
For example, presenting symptoms, examination findings, diagnosis etc.
Comment
0..1 DV_TEXT Additional narrative about the adverse reaction event not captured in other fields.
archetype (adl_version=1.4; uid=013e4061-fdf8-43c7-8661-779040ae10db)
	openEHR-EHR-CLUSTER.adverse_reaction_event.v1

concept
	[at0000]	-- Adverse reaction event
language
	original_language = <[ISO_639-1::en]>
	translations = <
		["nb"] = <
			language = <[ISO_639-1::nb]>
			author = <
				["name"] = <"Silje Ljosland Bakke">
				["organisation"] = <"Helse Vest IKT AS">
				["email"] = <"silje.ljosland.bakke@helse-vest-ikt.no">
			>
		>
	>
description
	original_author = <
		["name"] = <"Silje Ljosland Bakke">
		["organisation"] = <"Helse Vest IKT AS">
		["email"] = <"silje.ljosland.bakke@helse-vest-ikt.no">
		["date"] = <"2021-09-17">
	>
	details = <
		["nb"] = <
			language = <[ISO_639-1::nb]>
			purpose = <"For å registrere informasjon om en spesifikk overfølsomhetsreaksjonshendelse forårsaket av eksponering for en spesifikk substans.">
			use = <"Brukes for å registrere informasjon om en spesifikk overfølsomhetsreaksjonshendelse forårsaket av eksponering for en spesifikk substans. Substansen kan angis i elementet \"Spesifikk substans\" i denne arketypen, eller i et passende element i foreldrearketypen den er nøstet inni.

Denne arketypen er laget for å brukes innenfor arketypene EVALUATION.adverse_reaction_risk eller OBSERVATION.adverse_reaction_monitoring, for å registrere detaljer om en spesifikk reaksjonshendelse. Den kan likevel også brukes innenfor andre arketyper der det er klinisk passende.

Omfanget av denne arketypen er bevisst fokusert på å definere et pragmatisk datasett som brukes i de fleste kliniske systemer, eller vil være egnet for de fleste vanlige kliniske situasjoner. Den tillater imidlertid utvidelse av modellen når ekstra detaljer er nødvendig, ved å bruke SLOTene \"Reaksjonsdetaljer\", \"Eksponeringsdetaljer\", \"Detaljer om klinisk håndtering\" og \"Rapporteringsdetaljer\". Utvidelser kan være nødvendig for eksempel dersom en spesialist i allergologi eller immunologi skal registrere en mer detaljert vurdering som en del av rapportering til tilsynsorganer, eller innenfor i en klinisk studie.">
			misuse = <"Brukes ikke til å registrere uønskede hendelser, inkludert svikt i kliniske prosesser, intervensjoner eller produkter. For eksempel: Feil bruk eller feil gjort ved feilaktig administrering av en substans, feil dosering, feilmerking, skade forårsaket av en intervensjon eller prosedyre, overdose/forgiftning etc. Bruk en spesifikk arketype for dette formålet.">
		>
		["en"] = <
			language = <[ISO_639-1::en]>
			purpose = <"To record information about a specific adverse reaction event caused by exposure to a specific substance.">
			use = <"Use to record information about a specific adverse reaction event caused by exposure to a specific substance. The substance may be recorded in the 'Specific substance' element in this archetype, or in an appropriate element in the parent archetype in which this archetype is nested.

This archetype is designed to be nested within the EVALUATION.adverse_reaction_risk or the OBSERVATION.adverse_reaction_monitoring archetypes, to record details about a specific reaction event, but it could also be nested within other archetypes where clinically appropriate.

The scope of this archetype has deliberately focused on identifying a pragmatic data set that are used in most clinical systems or will be suitable for most common clinical scenarios; however, it permits extension of the model when additional detail is required, using the 'Reaction details', 'Exposure details', and 'Reporting details' slots. An extension may be required if a specialist allergist or immunologist needed to record a more detailed assessment as part of a report to regulatory bodies or within the context of a clinical trial.">
			misuse = <"Not to be used to record adverse events, including failures of clinical process, interventions or products. For example: abnormal use or mistakes/errors made in maladministration of an agent or substance; incorrect dosage; mislabelling; harm or injury caused by an intervention or procedure; overdose/poisoning etc. Use a specific archetype for this purpose.">
			copyright = <"© openEHR Foundation">
		>
	>
	lifecycle_state = <"published">
	other_contributors = <"Fatima Almeida, Critical SW, Portugal", "Grethe Almenning, Bergen kommune, Norway", "Magnus Alsaker, Helsedirektoratet, Norway", "Torunn Apelseth, Helse Bergen, Norway", "Vebjørn Arntzen, Oslo University Hospital, Norway", "Bent Asgeir Larsen, Helsedirektoratet, Norway", "Koray Atalag, University of Auckland, New Zealand", "Elaine Ayres, US National Institutes of Health, United States", "Russell B Leftwich MD, United States (openEHR Editor)", "Silje Ljosland Bakke, Helse Vest IKT AS, Norway (openEHR Editor)", "John Bennett, NEHTA, Australia", "Steve Bentley, Allscripts, United Kingdom", "Sharmila Biswas, Dr Sharmila Biswas GP, Australia", "Lars Bitsch-Larsen, Haukeland University hospital, Norway", "Terje Bless, Helse Nord FIKS, Norway", "Laila Bruun, Oslo universitetssykehus HF, Norway", "Claire Chalopin, ICCAS, University of Leipzig, Germany", "Rong Chen, Cambio Healthcare Systems, Sweden", "Stephen Chu, Queensland Health, Australia", "Matthew Cordell, NEHTA, Australia", "Howard Edidin, Edidin Group, Inc, United States", "Brett Esler, Oridashi, Australia", "David Evans, Queensland Health, Australia", "Jerry Fahrni, Kaweah Delta Health Care District, United States", "Shahla Foozonkhah, Iran ministry of health and education, Iran", "Einar Fosse, National Centre for Integrated Care and Telemedicine, Norway", "Joanne Foster, School of Nursing & Midwifery, QLD University of Technology & Nursing Informatics Australia, Australia", "Sebastian Garde, Ocean Informatics, Germany", "Jacquie Garton-Smith, Royal Perth Hospital and DoHWA, Australia", "Sarah Gaunt, NEHTA, Australia", "Andrew Goodchild, NEHTA, Australia", "Heather Grain, Llewelyn Grain Informatics, Australia", "Trina Gregory, cpc, Australia", "Grahame Grieve, Health Intersections, Australia (Editor)", "Robert Hausam, Hausam Consulting LLC, United States", "Sam Heard, Ocean Informatics, Australia", "Kristian Heldal, Telemark Hospital Trust, Norway", "Anca Heyd, DIPS ASA, Norway", "Hilde Hollås, Norway", "Roar Holm, Helse Vest IKT A/S, Norway", "Andrew James, University of Toronto, Canada", "Julie James, Blue Wave Informatics LLP, United Kingdom", "Tom Jarl Jakobsen, Helse Bergen, Norway", "Ivor Jones, Queensalnd Helath, Australia", "Lars Jostein Silihagen, Sopra Steria / Sykehuspartner / Sykehuset Innlandet, Norway", "Silje Kaada, Helse-Bergen, Avdeling for immunologi og transfusjonsmedisin, Norway", "Konstantinos Kalliamvakos, Cambio Healthcare Systems, Sweden", "Lars Karlsen, DIPS ASA, Norway", "Lars Morgan Karlsen, DIPS ASA, Norway", "Goran Karlstrom, County Of Värmland, Sweden", "Mary Kelaher, NEHTA, Australia", "Diane Kirkham, NEHTA, Australia", "Shinji Kobayashi, NPO openEHR Japan, Japan", "Robert L'egan, NEHTA, Australia", "Jobst Landgrebe, ii4sm, Switzerland", "Russell Leftwich, Russell B Leftwich MD, United States", "Fest Legemiddelverket, Statens Legemiddelverk, Norway", "Heather Leslie, Atomica Informatics, Australia (openEHR Editor)", "Hugh Leslie, Ocean Informatics, Australia", "Rikard Lovstrom, Swedish Medical Association, Sweden", "Hallvard Lærum, Oslo Universitetssykehus HF, Norway", "Arne Løberg Sæter, DIPS ASA, Norway", "Sarah Mahoney, Australia", "Luis Marco Ruiz, Norwegian Center for Integrated Care and Telemedicine, Norway", "Siv Marie Lien, DIPS ASA, Norway", "Mike Martyn, The Hobart Anaesthetic Group, Australia", "Lloyd McKenzie, Gordon Point Informatics, Canada", "David McKillop, NEHTA, Australia", "Ian McNicoll, freshEHR Clinical Informatics, United Kingdom", "Chris Mitchell, RACGP, Australia", "Stewart Morrison, NEHTA, Australia", "Jörg Niggemann, Compugroup, Germany", "Bjørn Næss, DIPS ASA, Norway", "Tom Oniki, Intermountain Healthcare, United States", "Chris Pearce, Melbourne East GP Network, Australia", "Rune Pedersen, Universitetssykehuset i Nord Norge, Norway", "General Practice Computing Group, Australia", "Camilla Preeston, Royal Australian College of General Practitioners, Australia", "Margaret Prichard, NEHTA, Australia", "Jodie Pycroft, Adelaide Northern Division of General Practice Ltd, Australia", "Cathy Richardson, NEHTA, Australia", "Robyn Richards, NEHTA - Clinical Terminology, Australia", "Tanja Riise, Nasjonal IKT HF, Norway", "Jussara Rotzsch, Hospital Alemão Oswaldo Cruz, Brazil", "Stefan Sauermann, University of Applied Sciences Technikum Wien, Austria", "Thomas Schopf, University Hospital of North-Norway, Norway", "Thilo Schuler, Australia", "Jason Scott, Plymouth Hospitals NHS Trust, United Kingdom", "Peter Scott, Medical Objects, Australia", "Elena Shabanova, UMMSSOft, Russian Federation", "Anoop Shah, University College London, United Kingdom", "Elizabeth Stanick, Hobart Anaesthetic Group, Australia", "Laila Storesund, Haraldsplass diakonale sykehus, Norway", "Norwegian Review Summary, Norwegian Public Hospitals, Norway", "Line Sæle, Nasjonal IKT HF, Norway", "Hwei-Yee Tai, Tan Tock Seng Hospital, Singapore", "John Taylor, NEHTA, Australia", "Micaela Thierley, Helse Bergen, Norway", "Gordon Tomes, Australian Institute of Health and Welfare, Australia", "John Tore Valand, Haukeland Universitetssjukehus, Norway (Nasjonal IKT redaktør)", "Richard Townley-O'Neill, Australian Digital Health Agency, Australia", "Ines Vaz, UFN, Portugal", "Nils Widnes, Helse-Bergen, Norway", "Andrew Yap, Australia", "Kylie Young, The Royal Australian College of General Practitioners, Australia", "Lin Zhang, Taikang Insurance Group, China">
	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"] = <"Derived from: Adverse reaction risk, Published archetype [Internet]. openEHR Foundation, openEHR Clinical Knowledge Manager [cited: 2021-10-04]. Available from: https://ckm.openehr.org/ckm/archetypes/1013.1.1713">
		["original_namespace"] = <"org.openehr">
		["original_publisher"] = <"openEHR Foundation">
		["custodian_namespace"] = <"org.openehr">
		["MD5-CAM-1.0.1"] = <"9D08CB073F56D7BC3A43AB8252ED1E03">
		["build_uid"] = <"19c2d37f-8a3b-403d-874d-04896dba8d1e">
		["revision"] = <"1.0.0">
	>

definition
	CLUSTER[at0000] matches {    -- Adverse reaction event
		items cardinality matches {1..*; unordered} matches {
			ELEMENT[at0001] occurrences matches {0..1} matches {    -- Specific substance
				value matches {
					DV_TEXT matches {*}
				}
			}
			ELEMENT[at0002] occurrences matches {0..1} matches {    -- Certainty
				value matches {
					DV_CODED_TEXT matches {
						defining_code matches {
							[local::
							at0026,    -- Unconfirmed
							at0005,    -- Confirmed
							at0027]    -- Refuted
						}
					}
					DV_TEXT matches {*}
				}
			}
			ELEMENT[at0006] occurrences matches {0..*} matches {    -- Manifestation
				value matches {
					DV_TEXT matches {*}
				}
			}
			ELEMENT[at0007] occurrences matches {0..1} matches {    -- Reaction description
				value matches {
					DV_TEXT matches {*}
				}
			}
			ELEMENT[at0008] occurrences matches {0..1} matches {    -- Onset of reaction
				value matches {
					DV_DATE_TIME matches {*}
				}
			}
			ELEMENT[at0009] occurrences matches {0..1} matches {    -- Duration of reaction
				value matches {
					DV_DURATION matches {*}
				}
			}
			ELEMENT[at0010] occurrences matches {0..1} matches {    -- Severity of reaction
				value matches {
					DV_CODED_TEXT matches {
						defining_code matches {
							[local::
							at0011,    -- Mild
							at0012,    -- Moderate
							at0013]    -- Severe
						}
					}
					DV_TEXT matches {*}
				}
			}
			allow_archetype CLUSTER[at0014] occurrences matches {0..*} matches {    -- Reaction details
				include
					archetype_id/value matches {/openEHR-EHR-CLUSTER\.anatomical_location(-[a-zA-Z0-9_]+)*\.v1|openEHR-EHR-CLUSTER\.media_file(-[a-zA-Z0-9_]+)*\.v1|openEHR-EHR-CLUSTER\.anatomical_location_relative(-[a-zA-Z0-9_]+)*\.v2|openEHR-EHR-CLUSTER\.symptom_sign(-[a-zA-Z0-9_]+)*\.v2|openEHR-EHR-CLUSTER\.ctcae(-[a-zA-Z0-9_]+)*\.v1/}
			}
			ELEMENT[at0015] occurrences matches {0..1} matches {    -- Initial exposure
				value matches {
					DV_DATE_TIME matches {*}
				}
			}
			ELEMENT[at0016] occurrences matches {0..1} matches {    -- Duration of exposure
				value matches {
					DV_DURATION matches {*}
				}
			}
			ELEMENT[at0017] occurrences matches {0..1} matches {    -- Route of exposure
				value matches {
					DV_TEXT matches {*}
				}
			}
			ELEMENT[at0018] occurrences matches {0..1} matches {    -- Exposure description
				value matches {
					DV_TEXT matches {*}
				}
			}
			allow_archetype CLUSTER[at0019] occurrences matches {0..*} matches {    -- Exposure details
				include
					archetype_id/value matches {/openEHR-EHR-CLUSTER\.citation(-[a-zA-Z0-9_]+)*\.v1|openEHR-EHR-CLUSTER\.citation(-[a-zA-Z0-9_]+)*\.v0/}
			}
			ELEMENT[at0020] occurrences matches {0..1} matches {    -- Clinical management description
				value matches {
					DV_TEXT matches {*}
				}
			}
			allow_archetype CLUSTER[at0021] occurrences matches {0..*} matches {    -- Clinical management details
				include
					archetype_id/value matches {/.*/}
			}
			allow_archetype CLUSTER[at0022] occurrences matches {0..*} matches {    -- Reporting details
				include
					archetype_id/value matches {/.*/}
			}
			allow_archetype CLUSTER[at0023] occurrences matches {0..*} matches {    -- Information source
				include
					archetype_id/value matches {/openEHR-EHR-CLUSTER\.organisation(-[a-zA-Z0-9_]+)*\.v1|openEHR-EHR-CLUSTER\.person(-[a-zA-Z0-9_]+)*\.v1/}
			}
			ELEMENT[at0025] occurrences matches {0..*} matches {    -- Supporting clinical record information
				value matches {
					DV_EHR_URI matches {*}
				}
			}
			ELEMENT[at0024] occurrences matches {0..1} matches {    -- Comment
				value matches {
					DV_TEXT matches {*}
				}
			}
		}
	}



ontology
	term_definitions = <
		["en"] = <
			items = <
				["at0000"] = <
					text = <"Adverse reaction event">
					description = <"Information about a specific adverse reaction event caused by exposure to a specific substance.">
				>
				["at0001"] = <
					text = <"Specific substance">
					description = <"The substance considered to be responsible for the specific adverse reaction event.">
					comment = <"For example: 'Amoxycillin'. Only an individual substance is a valid entry in 'Specific substance'. A substance may be a compound of simpler substances, for example a medicinal product. If the 'Substance' recorded in the archetype in which this archetype is nested is an individual substance and not a substance class, then it may be duplicated in this data element, or this element may be redundant. It is strongly recommended that 'Specific substance' be coded with a terminology, for example: RxNorm, SNOMED CT, DM+D, NDFRT, ICD-9, ICD-10, UNI, ATC or CPT.">
				>
				["at0002"] = <
					text = <"Certainty">
					description = <"The degree of clinical certainty that the 'Manifestation' in this reaction event was caused by exposure to the identified 'Specific substance'.">
					comment = <"The free text data type will allow for local variation by enabling other value sets to be applied to this data element in a template - in this situation it is recommended that values should be coded using a terminology.">
				>
				["at0005"] = <
					text = <"Confirmed">
					description = <"It has been objectively verified that the 'Manifestation' in this reaction event was caused by exposure to the identified 'Substance'. This may include clinical evidence by testing, re-challenge or observation.">
				>
				["at0006"] = <
					text = <"Manifestation">
					description = <"Clinical symptoms and/or signs that are observed or associated with the adverse reaction.">
					comment = <"Manifestation can be expressed as a single word, phrase or brief description. For example: nausea, rash. 'No reaction' may be appropriate where a previous reaction has been noted but the reaction did not re-occur after further exposure. It is preferable that 'Manifestation' should be coded with a terminology, where possible. The values entered here may be used to display on an application screen as part of a list of adverse reactions.">
				>
				["at0007"] = <
					text = <"Reaction description">
					description = <"Narrative description about the adverse reaction as a whole, including details of the manifestation if required.">
				>
				["at0008"] = <
					text = <"Onset of reaction">
					description = <"The date and/or time of the onset of the reaction.">
				>
				["at0009"] = <
					text = <"Duration of reaction">
					description = <"The total amount of time that the manifestation of the adverse reaction persisted.">
				>
				["at0010"] = <
					text = <"Severity of reaction">
					description = <"Clinical assessment of the severity of the reaction event as a whole, potentially considering multiple different manifestations.">
					comment = <"It is acknowledged that this assessment is very subjective. There may be some some specific practice domains where objective scales have been applied. Objective scales can be included in this model using the 'Reaction details' Cluster.">
				>
				["at0011"] = <
					text = <"Mild">
					description = <"Causes mild physiological effects.">
				>
				["at0012"] = <
					text = <"Moderate">
					description = <"Causes moderate physiological effects.">
				>
				["at0013"] = <
					text = <"Severe">
					description = <"Causes severe physiological effects.">
				>
				["at0014"] = <
					text = <"Reaction details">
					description = <"Additional details about the adverse reaction.">
					comment = <"May include structured detail about symptoms; the anatomical location of the manifestation; grading, classification or formal severity assessments such as Common Terminology Criteria for Adverse Events; or a media representation.">
				>
				["at0015"] = <
					text = <"Initial exposure">
					description = <"The date and/or time of the first exposure to the Substance for this Reaction Event.">
					comment = <"Exposure can be more complicated by more than one exposure events leading to a reaction. Further details about the nature of the exposure can be provided by use of additional archetypes in the 'Exposure details' SLOT or as text in the 'Exposure description'.">
				>
				["at0016"] = <
					text = <"Duration of exposure">
					description = <"The total amount of time the individual was exposed to the identified 'Specific substance'.">
				>
				["at0017"] = <
					text = <"Route of exposure">
					description = <"The route by which the subject was exposed to the identified 'Specific substance'.">
					comment = <"Coding of the Route of Exposure with a terminology should be used wherever possible.">
				>
				["at0018"] = <
					text = <"Exposure description">
					description = <"Narrative description about the exposure to the identified 'Specific substance'.">
				>
				["at0019"] = <
					text = <"Exposure details">
					description = <"Additional details about exposure to the 'Specific substance'.">
				>
				["at0020"] = <
					text = <"Clinical management description">
					description = <"Narrative description about the clinical management provided.">
				>
				["at0021"] = <
					text = <"Clinical management details">
					description = <"Additional structured details about clinical management for this reaction event.">
				>
				["at0022"] = <
					text = <"Reporting details">
					description = <"Additional structured details required for reporting to regulatory bodies.">
				>
				["at0023"] = <
					text = <"Information source">
					description = <"Details about the provenance of the information.">
					comment = <"This SLOT is intended to provide details about the source of information for this particular 'Reaction event'.">
				>
				["at0024"] = <
					text = <"Comment">
					description = <"Additional narrative about the adverse reaction event not captured in other fields.">
				>
				["at0025"] = <
					text = <"Supporting clinical record information">
					description = <"Link to further information about the presentation and findings that exist elsewhere in the health record, including allergy test reports.">
					comment = <"For example, presenting symptoms, examination findings, diagnosis etc.">
				>
				["at0026"] = <
					text = <"Unconfirmed">
					description = <"It has not been objectively verified that the 'Manifestation' in this reaction event was caused by exposure to the identified 'Substance'.">
				>
				["at0027"] = <
					text = <"Refuted">
					description = <"It has been disputed or disproven that the 'Manifestation' in this reaction event was caused by exposure to the identified 'Substance', with a sufficient level of clinical certainty to justify invalidating the assertion. This may include clinical evidence by testing, re-challenge or observation.">
				>
			>
		>
		["nb"] = <
			items = <
				["at0000"] = <
					text = <"Reaksjonshendelse">
					description = <"Informasjon om en spesifikk overfølsomhetsreaksjonshendelse forårsaket av eksponering for en spesifikk substans.">
				>
				["at0001"] = <
					text = <"Spesifikk substans">
					description = <"Substansen som anses for å være årsaken til den spesifikke reaksjonshendelsen.">
					comment = <"For eksempel \"Amoxicillin\". I feltet \"Spesifikk substans\" kan kun en spesifikk substans, og ikke en substansgruppe, registreres. En substans kan være en blanding av enkeltsubstanser, for eksempel et legemiddelprodukt. Om verdien som registreres i \"Substans\" i foreldrearketypen er en spesifikk substans kan verdien dupliseres i dette dataelementet. Det anbefales sterkt at \"Spesifikk substans\" kodes med en terminologi, for eksempel FEST, ATC eller SNOMED CT.">
				>
				["at0002"] = <
					text = <"Sikkerhet">
					description = <"Graden av klinisk sikkerhet om at reaksjonsmanifestasjonen av denne reaksjonshendelsen ble forårsaket av eksponering for den angitte substansen.">
					comment = <"Fritekst-datatypen tillater lokal variasjon ved å gjøre det mulig å legge til andre verdisett i et templat. I disse tilfellene er det anbefalt at verdiene kodes med en terminologi.">
				>
				["at0005"] = <
					text = <"Bekreftet">
					description = <"Det har blitt objektivt verifisert at manifestasjonen i denne reaksjonshendelsen ble forårsaket av eksponering for den angitte substansen. Dette kan omfatte klinisk evidens fra testing, provokasjonstesting eller observasjon.">
				>
				["at0006"] = <
					text = <"Reaksjonsmanifestasjon">
					description = <"Kliniske symptomer og/eller tegn som observeres eller assosieres med reaksjonen.">
					comment = <"Reaksjonsmanifestasjon kan uttrykkes som et enkeltord, en setning eller kort beskrivelse, for eksempel \"kvalme\" eller \"utslett\". \"Ingen reaksjon\" kan være passende når en reaksjon har skjedd tidligere, men ikke skjedde igjen ved ny eksponering. Det foretrekkes at reaksjonsmanifestasjon kodes ved hjelp av en terminologi når dette er mulig. Verdiene som registreres her kan vises i et skjermbilde som en del av en liste over uønskede reaksjoner.">
				>
				["at0007"] = <
					text = <"Reaksjonsbeskrivelse">
					description = <"En fritekstbeskrivelse om den uønskede reaksjonen som helhet, inklusiv detaljer om reaksjonsmanifestasjonen dersom påkrevd.">
				>
				["at0008"] = <
					text = <"Reaksjonsdebut">
					description = <"Dato og tidspunkt for når reaksjonen startet.">
				>
				["at0009"] = <
					text = <"Reaksjonens varighet">
					description = <"Den totale tidsperioden reaksjonsmanifestasjonen var tilstede.">
				>
				["at0010"] = <
					text = <"Reaksjonens alvorlighetsgrad">
					description = <"Klinisk vurdering av hendelsens alvorlighetsgrad som helhet, potensielt med vurderinger av de ulike manifestasjonene.">
					comment = <"Det anerkjennes at denne vurderingen er svært subjektiv. Det kan være noen kliniske områder hvor objektive scoringer brukes. Objektive scoringer kan inkluderes i denne modellen ved bruk av SLOTet \"Reaksjonsdetaljer\".">
				>
				["at0011"] = <
					text = <"Mild">
					description = <"Forårsaker milde fysiologiske effekter.">
				>
				["at0012"] = <
					text = <"Moderat">
					description = <"Forårsaker moderate fysiologiske effekter.">
				>
				["at0013"] = <
					text = <"Alvorlig">
					description = <"Forårsaker alvorlige fysiologiske effekter.">
				>
				["at0014"] = <
					text = <"Reaksjonsdetaljer">
					description = <"Ytterligere detaljer om den uønskede reaksjonen, f.eks. anatomisk lokalisering og/eller Common Terminology Criteria for Adverse Events, kan brukes ved inklusjon av spesifikke arketyper i dette SLOTet.">
					comment = <"Kan omfatte strukturerte detaljer om symptomer, den anatomiske lokaliseringen av manifestasjonen, gradering, klassifisering eller formelle vurderingskriterier for alvorlighetsgrad som Common Terminology Criteria for Adverse Events, eller en mediarepresentasjon.">
				>
				["at0015"] = <
					text = <"Første eksponering">
					description = <"Dato og tid for første eksponering for substansen i denne reaksjonshendelsen.">
					comment = <"Eksponering kan kompliseres ved at flere enn en eksponeringshendelse leder fram til en reaksjon. Videre detaljer om eksponeringen kan gis ved bruk av flere arketyper i SLOTet \"Eksponeringsdetaljer\" eller som tekst i \"Eksponeringsbeskrivelse\".">
				>
				["at0016"] = <
					text = <"Eksponeringsvarighet">
					description = <"Total tidsperiode som individet ble eksponert for den angitte substansen.">
				>
				["at0017"] = <
					text = <"Eksponeringsvei">
					description = <"Eksponeringsveien hvor subjektet ble eksponert for den angitte substansen.">
					comment = <"Eksponeringsvei bør kodes med en terminologi når mulig.">
				>
				["at0018"] = <
					text = <"Eksponeringsbeskrivelse">
					description = <"Fritekstbeskrivelse om eksponeringen for den angitte substansen.">
				>
				["at0019"] = <
					text = <"Eksponeringsdetaljer">
					description = <"Ytterligere detaljer om eksponeringen for den angitte substansen.">
				>
				["at0020"] = <
					text = <"Beskrivelse av klinisk håndtering">
					description = <"Fritekstbeskrivelse om den kliniske håndteringen av reaksjonen.">
				>
				["at0021"] = <
					text = <"Detaljer om klinisk håndtering">
					description = <"Ytterligere strukturerte detaljer om den kliniske håndteringen av reaksjonen.">
				>
				["at0022"] = <
					text = <"Rapporteringsdetaljer">
					description = <"Ytterligere strukturerte detaljer som kreves for rapportering til myndigheter.">
				>
				["at0023"] = <
					text = <"Informasjonskilde">
					description = <"Detaljer om informasjonskilde.">
					comment = <"Dette SLOTet er ment for detaljer om informasjonskilden for denne spesifikke reaksjonshendelsen.">
				>
				["at0024"] = <
					text = <"Reaksjonskommentar">
					description = <"Ytterligere fritekstkommentarer om reaksjonshendelsen som ikke fanges opp i andre felter.">
				>
				["at0025"] = <
					text = <"Understøttende journalinformasjon">
					description = <"Lenke til ytterligere informasjon om presentasjonen og funnene som finnes andre steder i journalen, inkludert resultatet av allergitesting.">
					comment = <"For eksempel symptomer, undersøkelsesfunn eller diagnoser.">
				>
				["at0026"] = <
					text = <"Ubekreftet">
					description = <"Det har ikke blitt objektivt verifisert at manifestasjonen i denne reaksjonshendelsen ble forårsaket av eksponering for den angitte substansen.">
				>
				["at0027"] = <
					text = <"Avkreftet">
					description = <"Det har blitt avkreftet at manifestasjonen i denne reaksjonshendelsen ble forårsaket av eksponering for den angitte substansen, med tilstrekkelig nivå av klinisk sikkerhet til at utsagnet kan invalideres. Dette kan omfatte klinisk evidens fra testing, provokasjonstesting eller observasjon.">
				>
			>
		>
	>