ARCHETYPE Adverse reaction event (openEHR-EHR-CLUSTER.adverse_reaction_event.v1)

ARCHETYPE IDopenEHR-EHR-CLUSTER.adverse_reaction_event.v1
ConceptAdverse reaction event
DescriptionInformation about a specific adverse reaction event caused by exposure to a specific substance.
UseUse 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.
MisuseNot 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.
PurposeTo record information about a specific adverse reaction event caused by exposure to a specific substance.
ReferencesDerived 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
Copyright© openEHR Foundation
AuthorsAuthor name: Silje Ljosland Bakke
Organisation: Helse Vest IKT AS
Email: silje.ljosland.bakke@helse-vest-ikt.no
Date originally authored: 2021-09-17
Other Details LanguageAuthor name: Silje Ljosland Bakke
Organisation: Helse Vest IKT AS
Email: silje.ljosland.bakke@helse-vest-ikt.no
Date originally authored: 2021-09-17
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=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=859E3E1B5E2CC7F763194716F7A8660B, build_uid=ef89065a-33cb-47ff-8f03-941bff0e7a87, revision=1.0.0}
Keywords
Lifecyclepublished
UID6b7ebf69-5b6d-4582-9036-e56f940f0a69
Language useden
Citeable Identifier1013.1.5795
Revision Number1.0.0
AllArchetype [runtimeNameConstraintForConceptName=null, archetypeConceptBinding=null, archetypeConceptDescription=Information about a specific adverse reaction event caused by exposure to a specific substance., archetypeConceptComment=null, otherContributors=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, originalLanguage=en, translators=
  • Norwegian Bokmål: Silje Ljosland Bakke, Helse Vest IKT AS, silje.ljosland.bakke@helse-vest-ikt.no

  • , subjectOfData=unconstrained, archetypeTranslationTree=null, topLevelToAshis={items=[ResourceSimplifiedHierarchyItem [path=/items[at0001], code=at0001, itemType=ELEMENT, level=1, 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., 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=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., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CHOICE, bindings=null, values=Choice of:
    •  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.]
    •  Text
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0006], code=at0006, itemType=ELEMENT, level=1, 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., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0007], code=at0007, itemType=ELEMENT, level=1, text=Reaction description, description=Narrative description about the adverse reaction as a whole, including details of the manifestation if required., 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], ResourceSimplifiedHierarchyItem [path=/items[at0008], code=at0008, itemType=ELEMENT, level=1, text=Onset of reaction, description=The date and/or time of the onset of the reaction., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0009], code=at0009, itemType=ELEMENT, level=1, text=Duration of reaction, description=The total amount of time that the manifestation of the adverse reaction persisted., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DURATION, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0010], code=at0010, itemType=ELEMENT, level=1, 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., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CHOICE, bindings=null, values=Choice of:
    •  Coded Text
      • Mild [Causes mild physiological effects.]
      • Moderate [Causes moderate physiological effects.]
      • Severe [Causes severe physiological effects.]
    •  Text
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0014], code=at0014, itemType=SLOT, level=1, 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., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
    openEHR-EHR-CLUSTER.anatomical_location.v1 and specialisations or
    openEHR-EHR-CLUSTER.media_file.v1 and specialisations or
    openEHR-EHR-CLUSTER.anatomical_location_relative.v2 and specialisations or
    openEHR-EHR-CLUSTER.symptom_sign.v2 and specialisations or
    openEHR-EHR-CLUSTER.ctcae.v1 and specialisations, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0015], code=at0015, itemType=ELEMENT, level=1, 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'., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0016], code=at0016, itemType=ELEMENT, level=1, text=Duration of exposure, description=The total amount of time the individual was exposed to the identified 'Specific substance'., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DURATION, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0017], code=at0017, itemType=ELEMENT, level=1, 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., 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[at0018], code=at0018, itemType=ELEMENT, level=1, text=Exposure description, description=Narrative description about the exposure to the identified 'Specific substance'., 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], ResourceSimplifiedHierarchyItem [path=/items[at0019], code=at0019, itemType=SLOT, level=1, text=Exposure details, description=Additional details about exposure to the 'Specific substance'., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
    openEHR-EHR-CLUSTER.citation.v1 and specialisations or
    openEHR-EHR-CLUSTER.citation.v0 and specialisations, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0020], code=at0020, itemType=ELEMENT, level=1, text=Clinical management description, description=Narrative description about the clinical management provided., 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], ResourceSimplifiedHierarchyItem [path=/items[at0021], code=at0021, itemType=SLOT, level=1, text=Clinical management details, description=Additional structured details about clinical management for this reaction event., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
    All not explicitly excluded archetypes, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0022], code=at0022, itemType=SLOT, level=1, text=Reporting details, description=Additional structured details required for reporting to regulatory bodies., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
    All not explicitly excluded archetypes, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0023], code=at0023, itemType=SLOT, level=1, 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'., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
    openEHR-EHR-CLUSTER.organisation.v1 and specialisations or
    openEHR-EHR-CLUSTER.person.v1 and specialisations, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0025], code=at0025, itemType=ELEMENT, level=1, 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., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_EHR_URI, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0024], code=at0024, itemType=ELEMENT, level=1, text=Comment, description=Additional narrative about the adverse reaction event not captured in other fields., 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]], description=[], context=[], activities=[], identities=[], capabilities=[], provider=[], protocol=[], content=[], source=[], credentials=[], events=[], data=[], contacts=[], ism_transition=[], details=[], relationships=[], state=[], target=[], 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=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., 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=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., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CHOICE, bindings=null, values=Choice of:
    •  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.]
    •  Text
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0006], code=at0006, itemType=ELEMENT, level=1, 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., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0007], code=at0007, itemType=ELEMENT, level=1, text=Reaction description, description=Narrative description about the adverse reaction as a whole, including details of the manifestation if required., 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], ResourceSimplifiedHierarchyItem [path=/items[at0008], code=at0008, itemType=ELEMENT, level=1, text=Onset of reaction, description=The date and/or time of the onset of the reaction., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0009], code=at0009, itemType=ELEMENT, level=1, text=Duration of reaction, description=The total amount of time that the manifestation of the adverse reaction persisted., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DURATION, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0010], code=at0010, itemType=ELEMENT, level=1, 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., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CHOICE, bindings=null, values=Choice of:
    •  Coded Text
      • Mild [Causes mild physiological effects.]
      • Moderate [Causes moderate physiological effects.]
      • Severe [Causes severe physiological effects.]
    •  Text
    , extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0014], code=at0014, itemType=SLOT, level=1, 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., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
    openEHR-EHR-CLUSTER.anatomical_location.v1 and specialisations or
    openEHR-EHR-CLUSTER.media_file.v1 and specialisations or
    openEHR-EHR-CLUSTER.anatomical_location_relative.v2 and specialisations or
    openEHR-EHR-CLUSTER.symptom_sign.v2 and specialisations or
    openEHR-EHR-CLUSTER.ctcae.v1 and specialisations, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0015], code=at0015, itemType=ELEMENT, level=1, 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'., uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0016], code=at0016, itemType=ELEMENT, level=1, text=Duration of exposure, description=The total amount of time the individual was exposed to the identified 'Specific substance'., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DURATION, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0017], code=at0017, itemType=ELEMENT, level=1, 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., 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[at0018], code=at0018, itemType=ELEMENT, level=1, text=Exposure description, description=Narrative description about the exposure to the identified 'Specific substance'., 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], ResourceSimplifiedHierarchyItem [path=/items[at0019], code=at0019, itemType=SLOT, level=1, text=Exposure details, description=Additional details about exposure to the 'Specific substance'., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
    openEHR-EHR-CLUSTER.citation.v1 and specialisations or
    openEHR-EHR-CLUSTER.citation.v0 and specialisations, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0020], code=at0020, itemType=ELEMENT, level=1, text=Clinical management description, description=Narrative description about the clinical management provided., 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], ResourceSimplifiedHierarchyItem [path=/items[at0021], code=at0021, itemType=SLOT, level=1, text=Clinical management details, description=Additional structured details about clinical management for this reaction event., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
    All not explicitly excluded archetypes, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0022], code=at0022, itemType=SLOT, level=1, text=Reporting details, description=Additional structured details required for reporting to regulatory bodies., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
    All not explicitly excluded archetypes, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0023], code=at0023, itemType=SLOT, level=1, 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'., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=Include:
    openEHR-EHR-CLUSTER.organisation.v1 and specialisations or
    openEHR-EHR-CLUSTER.person.v1 and specialisations, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0025], code=at0025, itemType=ELEMENT, level=1, 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., uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_EHR_URI, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/items[at0024], code=at0024, itemType=ELEMENT, level=1, text=Comment, description=Additional narrative about the adverse reaction event not captured in other fields., 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]