Nebenwirkung: AdverseEvent

This profile describes the adverse effects of radiotherapy and systemic therapy in oncology.The type of adverse effect can be described either as a CTCAE term or as a medDRA number. Further information can be found in the documentation guide https://plattform65c.atlassian.net/wiki/spaces/Dokumentat/pages/93683749/Nebenwirkungen. Additionally, the platform §65c provides a curated list with translated CTCAE terms and the corresponding medDRA numbers. https://plattform65c.atlassian.net/wiki/spaces/UMK/pages/15533115/Nebenwirkungen+CTCAE
NameStatusVersionCanonicalBasis
MII_PR_Onko_Nebenwirkung_Adverse_Eventactive2025.1.0https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-nebenwirkung-adverse-eventhttp://hl7.org/fhir/StructureDefinition/AdverseEvent

Content

idΣ0..1string
id0..1string
extensionC0..*Extension
versionIdΣ0..1id
lastUpdatedΣ0..1instant
sourceΣ0..1uri
profileS Σ0..*canonical(StructureDefinition)
securityΣ0..*CodingBinding
tagΣ0..*Coding
implicitRulesΣ ?!0..1uri
language0..1codeBinding
text0..1Narrative
contained0..*Resource
extensionC0..*Extension
modifierExtension?! C0..*Extension
identifierΣ0..1Identifier
actualityΣ ?!1..1codeBinding
categoryΣ0..*CodeableConceptBinding
id0..1string
extensionC0..*Extension
id0..1string
extensionC0..*Extension
systemS Σ1..1uri
versionS Σ0..1string
codeS Σ0..1codeBinding
displayΣ0..1string
userSelectedΣ0..1boolean
textS Σ0..1string
subjectS Σ1..1Reference(Patient)
encounterS Σ0..1Reference(Encounter)
dateΣ0..1dateTime
detectedΣ0..1dateTime
recordedDateΣ0..1dateTime
resultingConditionΣ0..*Reference(Condition)
locationΣ0..1Reference(Location)
id0..1string
extensionC0..*Extension
id0..1string
extensionC0..*Extension
systemS Σ1..1uri
versionΣ0..1string
codeS Σ1..1code
displayΣ0..1string
userSelectedΣ0..1boolean
textS Σ0..1string
severityΣ0..1CodeableConceptBinding
outcomeΣ0..1CodeableConceptBinding
recorderΣ0..1Reference(Patient | Practitioner | PractitionerRole | RelatedPerson)
contributorΣ0..*Reference(Practitioner | PractitionerRole | Device)
id0..1string
extensionC0..*Extension
modifierExtensionΣ ?! C0..*Extension
instanceS Σ1..1Reference(Procedure | MedicationStatement)
id0..1string
extensionC0..*Extension
modifierExtensionΣ ?! C0..*Extension
assessmentΣ0..1CodeableConcept
productRelatednessΣ0..1string
authorΣ0..1Reference(Practitioner | PractitionerRole)
methodΣ0..1CodeableConcept
subjectMedicalHistoryΣ0..*Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference)
referenceDocumentΣ0..*Reference(DocumentReference)
studyΣ0..*Reference(ResearchStudy)

Dieses Profil beschreibt die Nebenwirkung von Strahlentherapie und systemische Therapie in der Onkologie.

Query syntax is not valid. Location: select Field |Name: id, Short Description: short, Notes: comment
<StructureDefinition xmlns="http://hl7.org/fhir">
<id value="mii-pr-onko-nebenwirkung-adverse-event" />
<url value="https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-nebenwirkung-adverse-event" />
<version value="2025.1.0" />
<name value="MII_PR_Onko_Nebenwirkung_Adverse_Event" />
<title value="MII PR Onkologie Nebenwirkung von Strahlentherapie und systemische Therapie" />
<status value="active" />
<publisher value="Medizininformatik Initiative" />
<system value="url" />
<value value="https://www.medizininformatik-initiative.de" />
</telecom>
</contact>
<description value="Dieses Profil beschreibt die Nebenwirkung von Strahlentherapie und systemische Therapie in der Onkologie." />
<fhirVersion value="4.0.1" />
<identity value="oBDS" />
<name value="Mapping FHIR zu oBDS" />
</mapping>
<kind value="resource" />
<abstract value="false" />
<type value="AdverseEvent" />
<baseDefinition value="http://hl7.org/fhir/StructureDefinition/AdverseEvent" />
<derivation value="constraint" />
<element id="AdverseEvent.meta.profile">
<path value="AdverseEvent.meta.profile" />
<mustSupport value="true" />
</element>
<element id="AdverseEvent.event">
<path value="AdverseEvent.event" />
<min value="1" />
<mustSupport value="true" />
</element>
<element id="AdverseEvent.event.coding">
<path value="AdverseEvent.event.coding" />
<mustSupport value="true" />
</element>
<element id="AdverseEvent.event.coding.system">
<path value="AdverseEvent.event.coding.system" />
<min value="1" />
<mustSupport value="true" />
</element>
<element id="AdverseEvent.event.coding.version">
<path value="AdverseEvent.event.coding.version" />
<short value="CTCAE-Version">
<extension url="http://hl7.org/fhir/StructureDefinition/translation">
<extension url="lang">
<valueCode value="de-DE" />
</extension>
<extension url="content">
<valueString value="CTCAE-Version" />
</extension>
</extension>
</short>
<definition value="Version der für Art der Nebenwirkung verwendeten CTCAE-Klassifikation gemäß 15.3 oBDS 2021.">
<extension url="http://hl7.org/fhir/StructureDefinition/translation">
<extension url="lang">
<valueCode value="de-DE" />
</extension>
<extension url="content">
<valueString value="Version der für Art der Nebenwirkung verwendeten CTCAE-Klassifikation gemäß 15.3 oBDS 2021." />
</extension>
</extension>
</definition>
<mustSupport value="true" />
<identity value="oBDS" />
<map value="15.3" />
<comment value="Nebenwirkungen nach CTCAE Version" />
</mapping>
</element>
<element id="AdverseEvent.event.coding.code">
<path value="AdverseEvent.event.coding.code" />
<short value="Art der Nebenwirkung">
<extension url="http://hl7.org/fhir/StructureDefinition/translation">
<extension url="lang">
<valueCode value="de-DE" />
</extension>
<extension url="content">
<valueString value="Art der Nebenwirkung" />
</extension>
</extension>
</short>
<definition value="Art der Nebenwirkung nach CTCAE / MedDRA. Abweichend von 15.2 oBDS 2021 kann dieses Feld leer sein falls eine Nebenwirkung des Schweregrads 1 oder 2 vorliegt und keine spezifische Art der Nebenwirkung dokumentiert wurde">
<extension url="http://hl7.org/fhir/StructureDefinition/translation">
<extension url="lang">
<valueCode value="de-DE" />
</extension>
<extension url="content">
<valueString value="Art der Nebenwirkung nach CTCAE / MedDRA . Abweichend von 15.2 oBDS 2021 kann dieses Feld leer sein falls eine Nebenwirkung des Schweregrads 1 oder 2 vorliegt und keine spezifische Art der Nebenwirkung dokumentiert wurde" />
</extension>
</extension>
</definition>
<mustSupport value="true" />
<strength value="required" />
<valueSet value="https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/ValueSet/mii-vs-onko-nebenwirkung-art" />
</binding>
<identity value="oBDS" />
<map value="15.2" />
<comment value="Nebenwirkungen nach CTCAE Art" />
</mapping>
</element>
<element id="AdverseEvent.event.text">
<path value="AdverseEvent.event.text" />
<mustSupport value="true" />
</element>
<element id="AdverseEvent.subject">
<path value="AdverseEvent.subject" />
<code value="Reference" />
<targetProfile value="http://hl7.org/fhir/StructureDefinition/Patient" />
</type>
<mustSupport value="true" />
</element>
<element id="AdverseEvent.encounter">
<path value="AdverseEvent.encounter" />
<mustSupport value="true" />
</element>
<element id="AdverseEvent.seriousness">
<path value="AdverseEvent.seriousness" />
<min value="1" />
<mustSupport value="true" />
<strength value="required" />
<valueSet value="https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/ValueSet/mii-vs-onko-nebenwirkung-ctcae-grad" />
</binding>
<identity value="oBDS" />
<map value="15.1" />
<comment value="Nebenwirkungen nach CTCAE-Grad" />
</mapping>
</element>
<element id="AdverseEvent.seriousness.coding">
<path value="AdverseEvent.seriousness.coding" />
<short value="Schweregrad der Nebenwirkung nach CTCAE">
<extension url="http://hl7.org/fhir/StructureDefinition/translation">
<extension url="lang">
<valueCode value="de-DE" />
</extension>
<extension url="content">
<valueString value="Schweregrad der Nebenwirkung nach CTCAE" />
</extension>
</extension>
</short>
<definition value="Schweregrad der Nebenwirkung nach CTCAE gemäß 15.1 oBDS 2021.">
<extension url="http://hl7.org/fhir/StructureDefinition/translation">
<extension url="lang">
<valueCode value="de-DE" />
</extension>
<extension url="content">
<valueString value="Schweregrad der Nebenwirkung nach CTCAE gemäß 15.1 oBDS 2021." />
</extension>
</extension>
</definition>
<mustSupport value="true" />
</element>
<element id="AdverseEvent.seriousness.coding.system">
<path value="AdverseEvent.seriousness.coding.system" />
<min value="1" />
<mustSupport value="true" />
</element>
<element id="AdverseEvent.seriousness.coding.code">
<path value="AdverseEvent.seriousness.coding.code" />
<min value="1" />
<mustSupport value="true" />
</element>
<element id="AdverseEvent.seriousness.text">
<path value="AdverseEvent.seriousness.text" />
<mustSupport value="true" />
</element>
<element id="AdverseEvent.suspectEntity">
<path value="AdverseEvent.suspectEntity" />
<min value="1" />
<mustSupport value="true" />
</element>
<element id="AdverseEvent.suspectEntity.instance">
<path value="AdverseEvent.suspectEntity.instance" />
<code value="Reference" />
<targetProfile value="http://hl7.org/fhir/StructureDefinition/Procedure" />
<targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicationStatement" />
</type>
<mustSupport value="true" />
</element>
</differential>
</StructureDefinition>
{
"resourceType": "StructureDefinition",
"id": "mii-pr-onko-nebenwirkung-adverse-event",
"url": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-nebenwirkung-adverse-event",
"version": "2025.1.0",
"name": "MII_PR_Onko_Nebenwirkung_Adverse_Event",
"title": "MII PR Onkologie Nebenwirkung von Strahlentherapie und systemische Therapie",
"status": "active",
"publisher": "Medizininformatik Initiative",
"contact": [
{
"telecom": [
{
"system": "url",
"value": "https://www.medizininformatik-initiative.de"
}
]
}
],
"description": "Dieses Profil beschreibt die Nebenwirkung von Strahlentherapie und systemische Therapie in der Onkologie.",
"fhirVersion": "4.0.1",
"mapping": [
{
"identity": "oBDS",
"name": "Mapping FHIR zu oBDS"
}
],
"kind": "resource",
"abstract": false,
"type": "AdverseEvent",
"baseDefinition": "http://hl7.org/fhir/StructureDefinition/AdverseEvent",
"derivation": "constraint",
"element": [
{
"id": "AdverseEvent.meta.profile",
"path": "AdverseEvent.meta.profile",
"mustSupport": true
},
{
"id": "AdverseEvent.event",
"path": "AdverseEvent.event",
"min": 1,
"mustSupport": true
},
{
"id": "AdverseEvent.event.coding",
"path": "AdverseEvent.event.coding",
"mustSupport": true
},
{
"id": "AdverseEvent.event.coding.system",
"path": "AdverseEvent.event.coding.system",
"min": 1,
"mustSupport": true
},
{
"id": "AdverseEvent.event.coding.version",
"path": "AdverseEvent.event.coding.version",
"short": "CTCAE-Version",
"_short": {
{
"url": "http://hl7.org/fhir/StructureDefinition/translation",
{
"url": "lang",
"valueCode": "de-DE"
},
{
"url": "content",
"valueString": "CTCAE-Version"
}
]
}
]
},
"definition": "Version der für Art der Nebenwirkung verwendeten CTCAE-Klassifikation gemäß 15.3 oBDS 2021.",
{
"url": "http://hl7.org/fhir/StructureDefinition/translation",
{
"url": "lang",
"valueCode": "de-DE"
},
{
"url": "content",
"valueString": "Version der für Art der Nebenwirkung verwendeten CTCAE-Klassifikation gemäß 15.3 oBDS 2021."
}
]
}
]
},
"mustSupport": true,
"mapping": [
{
"identity": "oBDS",
"map": "15.3",
"comment": "Nebenwirkungen nach CTCAE Version"
}
]
},
{
"id": "AdverseEvent.event.coding.code",
"path": "AdverseEvent.event.coding.code",
"short": "Art der Nebenwirkung",
"_short": {
{
"url": "http://hl7.org/fhir/StructureDefinition/translation",
{
"url": "lang",
"valueCode": "de-DE"
},
{
"url": "content",
"valueString": "Art der Nebenwirkung"
}
]
}
]
},
"definition": "Art der Nebenwirkung nach CTCAE / MedDRA. Abweichend von 15.2 oBDS 2021 kann dieses Feld leer sein falls eine Nebenwirkung des Schweregrads 1 oder 2 vorliegt und keine spezifische Art der Nebenwirkung dokumentiert wurde",
{
"url": "http://hl7.org/fhir/StructureDefinition/translation",
{
"url": "lang",
"valueCode": "de-DE"
},
{
"url": "content",
"valueString": "Art der Nebenwirkung nach CTCAE / MedDRA . Abweichend von 15.2 oBDS 2021 kann dieses Feld leer sein falls eine Nebenwirkung des Schweregrads 1 oder 2 vorliegt und keine spezifische Art der Nebenwirkung dokumentiert wurde"
}
]
}
]
},
"mustSupport": true,
"binding": {
"strength": "required",
"valueSet": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/ValueSet/mii-vs-onko-nebenwirkung-art"
},
"mapping": [
{
"identity": "oBDS",
"map": "15.2",
"comment": "Nebenwirkungen nach CTCAE Art"
}
]
},
{
"id": "AdverseEvent.event.text",
"path": "AdverseEvent.event.text",
"mustSupport": true
},
{
"id": "AdverseEvent.subject",
"path": "AdverseEvent.subject",
"type": [
{
"code": "Reference",
"http://hl7.org/fhir/StructureDefinition/Patient"
]
}
],
"mustSupport": true
},
{
"id": "AdverseEvent.encounter",
"path": "AdverseEvent.encounter",
"mustSupport": true
},
{
"id": "AdverseEvent.seriousness",
"path": "AdverseEvent.seriousness",
"min": 1,
"mustSupport": true,
"binding": {
"strength": "required",
"valueSet": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/ValueSet/mii-vs-onko-nebenwirkung-ctcae-grad"
},
"mapping": [
{
"identity": "oBDS",
"map": "15.1",
"comment": "Nebenwirkungen nach CTCAE-Grad"
}
]
},
{
"id": "AdverseEvent.seriousness.coding",
"path": "AdverseEvent.seriousness.coding",
"short": "Schweregrad der Nebenwirkung nach CTCAE",
"_short": {
{
"url": "http://hl7.org/fhir/StructureDefinition/translation",
{
"url": "lang",
"valueCode": "de-DE"
},
{
"url": "content",
"valueString": "Schweregrad der Nebenwirkung nach CTCAE"
}
]
}
]
},
"definition": "Schweregrad der Nebenwirkung nach CTCAE gemäß 15.1 oBDS 2021.",
{
"url": "http://hl7.org/fhir/StructureDefinition/translation",
{
"url": "lang",
"valueCode": "de-DE"
},
{
"url": "content",
"valueString": "Schweregrad der Nebenwirkung nach CTCAE gemäß 15.1 oBDS 2021."
}
]
}
]
},
"mustSupport": true
},
{
"id": "AdverseEvent.seriousness.coding.system",
"path": "AdverseEvent.seriousness.coding.system",
"min": 1,
"mustSupport": true
},
{
"id": "AdverseEvent.seriousness.coding.code",
"path": "AdverseEvent.seriousness.coding.code",
"min": 1,
"mustSupport": true
},
{
"id": "AdverseEvent.seriousness.text",
"path": "AdverseEvent.seriousness.text",
"mustSupport": true
},
{
"id": "AdverseEvent.suspectEntity",
"path": "AdverseEvent.suspectEntity",
"min": 1,
"mustSupport": true
},
{
"id": "AdverseEvent.suspectEntity.instance",
"path": "AdverseEvent.suspectEntity.instance",
"type": [
{
"code": "Reference",
"http://hl7.org/fhir/StructureDefinition/Procedure",
"http://hl7.org/fhir/StructureDefinition/MedicationStatement"
]
}
],
"mustSupport": true
}
]
}
}

Mapping dataset to FHIR
DatasetExplanationFHIR
Nebenwirkungen

Nebenwirkungen

Nebenwirkungen nach CTCAE-Grad

Gibt an, zu welchem Schweregrad von Nebenwirkungen es bei der Bestrahlung oder der systemischen Therapie gekommen ist.

AdverseEvent.seriousness.coding.code
Nebenwirkungen nach CTCAE Art

Gibt an, zu welcher Nebenwirkung es bei der Bestrahlung oder der systemischen Therapie gekommen ist. Bei der Bestrahlung sind sogenannte akute Nebenwirkungen bis zum 90. Tag nach Bestrahlungsbeginn gemeint.

AdverseEvent.event.coding.code
Nebenwirkungen nach CTCAE Version

Für den medizinischen Katalog gültige Versionsbezeichnungen.

AdverseEvent.event.coding.version

Mapping Unified Oncological Basic Dataset (oBDS) to FHIR
oBDSDefinitionFHIR
15.3Nebenwirkungen nach CTCAE VersionAdverseEvent.event.coding.version
15.2Nebenwirkungen nach CTCAE ArtAdverseEvent.event.coding.code
15.1Nebenwirkungen nach CTCAE-GradAdverseEvent.seriousness

Search ParametersThe following search parameters are relevant for the oncology module, also in combination:
  1. The search parameter _id MUST be supported:

    Examples:

    GET [base]/AdverseEvent?_id=1234

    Application notes: Further information on searching by "_id" can be found in the FHIR base specification - section "Parameters for all resources".

  2. The search parameter _profile MUST be supported:

    Examples:

    GET [base]/AdverseEvent?_profile=https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-nebenwirkung-adverse-event

    Application notes: Further information on searching by "_profile" can be found in the FHIR base specification - section "token".

  3. The search parameter event MUST be supported: Examples:

    GET [base]/AdverseEvent?event=https://www.meddra.org|10016256

    Application notes: Further information on searching by "event" can be found in the FHIR base specification - section "token".

  4. The search parameter seriousness MUST be supported:

    Examples:

    GET [base]/AdverseEvent?seriousness=https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-nebenwirkung-ctcae-grad|4

    Application notes: Further information on searching by "seriousness" can be found in the FHIR base specification - section "token".

  5. The search parameter suspectEntity.instance MUST be supported:

    Examples:

    GET [base]/AdverseEvent?suspectEntity.instance=Patient/example

    Application notes: Further information on searching by "severity" can be found in the FHIR base specification - section "reference".

Examples
{
"resourceType": "AdverseEvent",
"id": "mii-pr-onko-nebenwirkung-0",
"meta": {
"profile": [
"https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-nebenwirkung-adverse-event"
]
},
"actuality": "actual",
"event": {
"coding": [
{
"code": "10016256",
"system": "https://www.meddra.org",
"display": "Fatigue",
"version": "Version 4"
}
]
},
"subject": {
"reference": "Patient/example"
},
"coding": [
{
"code": "4",
"system": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-nebenwirkung-ctcae-grad",
"display": "Lebensbedrohlich"
}
]
},
{
"reference": "Procedure/Strahlentherapie"
}
}
]
}
Adverse effect without MedDRA-Coding:
{
"resourceType": "AdverseEvent",
"id": "mii-pr-onko-nebenwirkung-text",
"meta": {
"profile": [
"https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-nebenwirkung-adverse-event"
]
},
"actuality": "actual",
"event": {
"text": "Schüttelfrost"
},
"subject": {
"reference": "Patient/example"
},
"coding": [
{
"code": "3",
"system": "https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-nebenwirkung-ctcae-grad",
"display": "schwerwiegend"
}
]
},
{
"reference": "Procedure/Strahlentherapie"
}
}
]
}