description: Dieses Profil beschreibt die Nebenwirkung von Strahlentherapie und systemische Therapie in der Onkologie.
package_name: de.medizininformatikinitiative.kerndatensatz.onkologie
derivation: constraint
name: MII_PR_Onko_Nebenwirkung_Adverse_Event
type: AdverseEvent
elements:
  meta:
    elements:
      profile: {mustSupport: true, index: 0}
  event:
    binding: {strength: required, valueSet: 'https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/ValueSet/mii-vs-onko-nebenwirkung-art'}
    mustSupport: true
    index: 1
    elements:
      coding:
        mustSupport: true
        index: 2
        elements:
          system: {mustSupport: true, index: 3}
          version:
            short: CTCAE-Version
            _short:
              extension:
              - url: http://hl7.org/fhir/StructureDefinition/translation
                extension:
                - {url: lang, valueCode: de-DE}
                - {url: content, valueString: CTCAE-Version}
            _definition:
              extension:
              - url: http://hl7.org/fhir/StructureDefinition/translation
                extension:
                - {url: lang, valueCode: de-DE}
                - {url: content, valueString: Version der für Art der Nebenwirkung verwendeten CTCAE-Klassifikation gemäß 15.3 oBDS 2021.}
            mustSupport: true
            index: 4
          code:
            short: Art der Nebenwirkung
            _definition:
              extension:
              - url: http://hl7.org/fhir/StructureDefinition/translation
                extension:
                - {url: lang, valueCode: de-DE}
                - {url: content, valueString: Art der Nebenwirkung nach CTCAE / MedDRA gemäß 15.2 oBDS 2021.}
            mustSupport: true
            _short:
              extension:
              - url: http://hl7.org/fhir/StructureDefinition/translation
                extension:
                - {url: lang, valueCode: de-DE}
                - {url: content, valueString: Art der Nebenwirkung}
            index: 5
        required: [system, code]
      text: {mustSupport: true, index: 6}
    required: [coding]
  subject:
    type: Reference
    mustSupport: true
    refers: ['http://hl7.org/fhir/StructureDefinition/Patient']
    index: 7
  encounter: {mustSupport: true, index: 8}
  seriousness:
    binding: {strength: required, valueSet: 'https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/ValueSet/mii-vs-onko-nebenwirkung-ctcae-grad'}
    mustSupport: true
    index: 9
    elements:
      coding:
        short: Schweregrad der Nebenwirkung nach CTCAE
        _short:
          extension:
          - url: http://hl7.org/fhir/StructureDefinition/translation
            extension:
            - {url: lang, valueCode: de-DE}
            - {url: content, valueString: Schweregrad der Nebenwirkung nach CTCAE}
        _definition:
          extension:
          - url: http://hl7.org/fhir/StructureDefinition/translation
            extension:
            - {url: lang, valueCode: de-DE}
            - {url: content, valueString: Schweregrad der Nebenwirkung nach CTCAE gemäß 15.1 oBDS 2021.}
        mustSupport: true
        index: 10
        elements:
          system: {mustSupport: true, index: 11}
          code: {mustSupport: true, index: 12}
        required: [system, code]
      text: {mustSupport: true, index: 13}
  suspectEntity:
    mustSupport: true
    index: 14
    elements:
      instance:
        type: Reference
        mustSupport: true
        refers: ['http://hl7.org/fhir/StructureDefinition/MedicationStatement', 'http://hl7.org/fhir/StructureDefinition/Procedure']
        index: 15
package_version: 2025.0.3
class: profile
kind: resource
url: https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-nebenwirkung-adverse-event
base: http://hl7.org/fhir/StructureDefinition/AdverseEvent
version: 2025.0.0
required: [suspectEntity, event, seriousness]