MII IG Kerndatensatz-Modul Onkologie
2027.0.0-ballot.1 - Germany

This page is part of the MII IG Kerndatensatz-Modul Onkologie (v2027.0.0-ballot.1: Release) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Resource Profile: MII PR Onkologie Nebenwirkung von Strahlentherapie und systemische Therapie

Official URL: https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-pr-onko-nebenwirkung-adverse-event Version: 2027.0.0-ballot.1
Active as of 2026-09-15 Computable Name: MII_PR_Onko_Nebenwirkung_Adverse_Event

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

This profile describes the adverse event of radiotherapy and systemic therapy in oncology.

The type of adverse event 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 In addition, the Plattform §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

In deviation from the oBDS, this profile also allows events of severity grades 1 and 2 to be explicitly specified. As a result, it may happen that the cancer registry data does not record at all what type of adverse event is involved. In

Mapping of dataset to FHIR

The mapping of the dataset fields is documented in the logical model: MII LM Onkologie.

Mapping Einheitlicher onkologischer Basisdatensatz (oBDS) to FHIR

The oBDS mappings are recorded in the artefact view of this profile: MII PR Onkologie Nebenwirkung von Strahlentherapie und systemische Therapie.

Examples

mii-pr-onko-nebenwirkung-0

Adverse event without MedDRA coding:

mii-pr-onko-nebenwirkung-text

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots, and their representations.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AdverseEvent C 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
Constraints: nebenwirkung-grad3-art
... meta Σ 0..1 Meta Metadata about the resource
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:ctcaeVersion S 0..1 CodeableConcept CTCAE-Version
URL: https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-ex-onko-nebenwirkung-ctcae-version
Binding: MII VS Onkologie Nebenwirkung CTCAE-Version (required)
... actuality ?!Σ 1..1 code actual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
... event SΣ 1..1 CodeableConcept Type of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.
.... Slices for coding SΣ 0..* Coding Code defined by a terminology system
Slice: Unordered, Open by pattern:system
..... coding:All Slices Content/Rules for all slices
...... system SΣ 1..1 uri Identity of the terminology system
...... version SΣ 0..1 string CTCAE-Version
...... code SΣ 0..1 code Art der Nebenwirkung
..... coding:meddra SΣ 0..1 Coding Code defined by a terminology system
Binding: MII VS Onkologie Nebenwirkung nach CTCAE Art (required)
...... system SΣ 1..1 uri Identity of the terminology system
Required Pattern: https://www.meddra.org
...... version SΣ 0..1 string CTCAE-Version
...... code SΣ 1..1 code Art der Nebenwirkung
..... coding:snomed SΣ 0..1 Coding Art der Nebenwirkung (SNOMED CT)
...... system SΣ 1..1 uri Identity of the terminology system
Required Pattern: http://snomed.info/sct
...... version SΣ 0..1 string CTCAE-Version
...... code SΣ 1..1 code Art der Nebenwirkung
.... text SΣ 0..1 string Plain text representation of the concept
... subject SΣ 1..1 Reference(Patient) Subject impacted by event
... encounter SΣ 0..1 Reference(Encounter) Encounter created as part of
... seriousness SΣ 1..1 CodeableConcept Seriousness of the event
Binding: MII VS Onkologie Nebenwirkung nach CTCAE Grad (required)
.... coding SΣ 0..* Coding Schweregrad der Nebenwirkung nach CTCAE
..... system SΣ 1..1 uri Identity of the terminology system
..... code SΣ 1..1 code Symbol in syntax defined by the system
.... text SΣ 0..1 string Plain text representation of the concept
... suspectEntity SΣ 1..* BackboneElement The suspected agent causing the adverse event
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... instance SΣ 1..1 Reference(MII PR Onkologie Strahlentherapie | MII PR Onkologie Systemische Therapie | MII PR Onkologie Systemische Therapie Medikation) Refers to the specific entity that caused the adverse event

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
AdverseEvent.actuality Base required AdverseEventActuality 📍4.0.1 FHIR Std.
AdverseEvent.event Base example SNOMED CT Clinical Findings 📍4.0.1 FHIR Std.
AdverseEvent.event.coding:meddra Base required MII VS Onkologie Nebenwirkung nach CTCAE Art 📦2027.0.0-ballot.1 This IG
AdverseEvent.seriousness Base required MII VS Onkologie Nebenwirkung nach CTCAE Grad 📦2027.0.0-ballot.1 This IG

Constraints

Id Grade Path(s) Description Expression
dom-2 error AdverseEvent If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error AdverseEvent If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error AdverseEvent If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error AdverseEvent If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice AdverseEvent A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
nebenwirkung-grad3-art warning AdverseEvent Bei CTCAE-Schweregrad 3, 4 oder 5 muss die Art der Nebenwirkung (event.coding) angegeben sein. Bei Grad 1/2 darf sie fehlen (oBDS 15.2). seriousness.coding.where(system = 'https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-nebenwirkung-ctcae-grad' and (code = '3' or code = '4' or code = '5')).exists() implies event.coding.exists()

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AdverseEvent C 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
Constraints: nebenwirkung-grad3-art
... meta
.... profile S 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:ctcaeVersion S 0..1 CodeableConcept CTCAE-Version
URL: https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-ex-onko-nebenwirkung-ctcae-version
Binding: MII VS Onkologie Nebenwirkung CTCAE-Version (required)
... event S 1..1 CodeableConcept Type of the event itself in relation to the subject
.... Slices for coding S 0..* Coding Code defined by a terminology system
Slice: Unordered, Open by pattern:system
..... coding:All Slices Content/Rules for all slices
...... system S 1..1 uri Identity of the terminology system
...... version S 0..1 string CTCAE-Version
...... code S 0..1 code Art der Nebenwirkung
..... coding:meddra S 0..1 Coding Code defined by a terminology system
Binding: MII VS Onkologie Nebenwirkung nach CTCAE Art (required)
...... system S 1..1 uri Identity of the terminology system
Required Pattern: https://www.meddra.org
...... version S 0..1 string CTCAE-Version
...... code S 1..1 code Art der Nebenwirkung
..... coding:snomed S 0..1 Coding Art der Nebenwirkung (SNOMED CT)
...... system S 1..1 uri Identity of the terminology system
Required Pattern: http://snomed.info/sct
...... version S 0..1 string CTCAE-Version
...... code S 1..1 code Art der Nebenwirkung
.... text S 0..1 string Plain text representation of the concept
... encounter S 0..1 Reference(Encounter) Encounter created as part of
... seriousness S 1..1 CodeableConcept Seriousness of the event
Binding: MII VS Onkologie Nebenwirkung nach CTCAE Grad (required)
.... coding S 0..* Coding Schweregrad der Nebenwirkung nach CTCAE
..... system S 1..1 uri Identity of the terminology system
..... code S 1..1 code Symbol in syntax defined by the system
.... text S 0..1 string Plain text representation of the concept
... suspectEntity S 1..* BackboneElement The suspected agent causing the adverse event
.... instance S 1..1 Reference(MII PR Onkologie Strahlentherapie | MII PR Onkologie Systemische Therapie | MII PR Onkologie Systemische Therapie Medikation) Refers to the specific entity that caused the adverse event

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
AdverseEvent.event.coding:meddra Base required MII VS Onkologie Nebenwirkung nach CTCAE Art 📦2027.0.0-ballot.1 This IG
AdverseEvent.seriousness Base required MII VS Onkologie Nebenwirkung nach CTCAE Grad 📦2027.0.0-ballot.1 This IG

Constraints

Id Grade Path(s) Description Expression
nebenwirkung-grad3-art warning AdverseEvent Bei CTCAE-Schweregrad 3, 4 oder 5 muss die Art der Nebenwirkung (event.coding) angegeben sein. Bei Grad 1/2 darf sie fehlen (oBDS 15.2). seriousness.coding.where(system = 'https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-nebenwirkung-ctcae-grad' and (code = '3' or code = '4' or code = '5')).exists() implies event.coding.exists()
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AdverseEvent C 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
Constraints: nebenwirkung-grad3-art
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ 0..1 id Version specific identifier
.... lastUpdated Σ 0..1 instant When the resource version last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.
Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:ctcaeVersion S 0..1 CodeableConcept CTCAE-Version
URL: https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-ex-onko-nebenwirkung-ctcae-version
Binding: MII VS Onkologie Nebenwirkung CTCAE-Version (required)
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..1 Identifier Business identifier for the event
... actuality ?!Σ 1..1 code actual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
... category Σ 0..* CodeableConcept product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational.
... event SΣ 1..1 CodeableConcept Type of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... Slices for coding SΣ 0..* Coding Code defined by a terminology system
Slice: Unordered, Open by pattern:system
..... coding:All Slices Content/Rules for all slices
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system SΣ 1..1 uri Identity of the terminology system
...... version SΣ 0..1 string CTCAE-Version
...... code SΣ 0..1 code Art der Nebenwirkung
...... display Σ 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... coding:meddra SΣ 0..1 Coding Code defined by a terminology system
Binding: MII VS Onkologie Nebenwirkung nach CTCAE Art (required)
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system SΣ 1..1 uri Identity of the terminology system
Required Pattern: https://www.meddra.org
...... version SΣ 0..1 string CTCAE-Version
...... code SΣ 1..1 code Art der Nebenwirkung
...... display Σ 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... coding:snomed SΣ 0..1 Coding Art der Nebenwirkung (SNOMED CT)
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system SΣ 1..1 uri Identity of the terminology system
Required Pattern: http://snomed.info/sct
...... version SΣ 0..1 string CTCAE-Version
...... code SΣ 1..1 code Art der Nebenwirkung
...... display Σ 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text SΣ 0..1 string Plain text representation of the concept
... subject SΣ 1..1 Reference(Patient) Subject impacted by event
... encounter SΣ 0..1 Reference(Encounter) Encounter created as part of
... date Σ 0..1 dateTime When the event occurred
... detected Σ 0..1 dateTime When the event was detected
... recordedDate Σ 0..1 dateTime When the event was recorded
... resultingCondition Σ 0..* Reference(Condition) Effect on the subject due to this event
... location Σ 0..1 Reference(Location) Location where adverse event occurred
... seriousness SΣ 1..1 CodeableConcept Seriousness of the event
Binding: MII VS Onkologie Nebenwirkung nach CTCAE Grad (required)
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding SΣ 0..* Coding Schweregrad der Nebenwirkung nach CTCAE
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system SΣ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code SΣ 1..1 code Symbol in syntax defined by the system
..... display Σ 0..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text SΣ 0..1 string Plain text representation of the concept
... severity Σ 0..1 CodeableConcept mild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.
... outcome Σ 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).
... recorder Σ 0..1 Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) Who recorded the adverse event
... contributor Σ 0..* Reference(Practitioner | PractitionerRole | Device) Who was involved in the adverse event or the potential adverse event
... suspectEntity SΣ 1..* BackboneElement The suspected agent causing the adverse event
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... instance SΣ 1..1 Reference(MII PR Onkologie Strahlentherapie | MII PR Onkologie Systemische Therapie | MII PR Onkologie Systemische Therapie Medikation) Refers to the specific entity that caused the adverse event
.... causality Σ 0..* BackboneElement Information on the possible cause of the event
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... assessment Σ 0..1 CodeableConcept Assessment of if the entity caused the event
Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.
..... productRelatedness Σ 0..1 string AdverseEvent.suspectEntity.causalityProductRelatedness
..... author Σ 0..1 Reference(Practitioner | PractitionerRole) AdverseEvent.suspectEntity.causalityAuthor
..... method Σ 0..1 CodeableConcept ProbabilityScale | Bayesian | Checklist
Binding: AdverseEventCausalityMethod (example): TODO.
... subjectMedicalHistory Σ 0..* Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) AdverseEvent.subjectMedicalHistory
... referenceDocument Σ 0..* Reference(DocumentReference) AdverseEvent.referenceDocument
... study Σ 0..* Reference(ResearchStudy) AdverseEvent.study

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
AdverseEvent.meta.security Base extensible SecurityLabels 📍4.0.1 FHIR Std.
AdverseEvent.meta.tag Base example Common Tags 📍4.0.1 FHIR Std.
AdverseEvent.language Base preferred Common Languages 📍4.0.1 FHIR Std.
AdverseEvent.actuality Base required AdverseEventActuality 📍4.0.1 FHIR Std.
AdverseEvent.category Base extensible AdverseEventCategory 📍4.0.1 FHIR Std.
AdverseEvent.event Base example SNOMED CT Clinical Findings 📍4.0.1 FHIR Std.
AdverseEvent.event.coding:meddra Base required MII VS Onkologie Nebenwirkung nach CTCAE Art 📦2027.0.0-ballot.1 This IG
AdverseEvent.seriousness Base required MII VS Onkologie Nebenwirkung nach CTCAE Grad 📦2027.0.0-ballot.1 This IG
AdverseEvent.severity Base required AdverseEventSeverity 📍4.0.1 FHIR Std.
AdverseEvent.outcome Base required AdverseEventOutcome 📍4.0.1 FHIR Std.
AdverseEvent.suspectEntity.​causality.assessment Base example AdverseEventCausalityAssessment 📍4.0.1 FHIR Std.
AdverseEvent.suspectEntity.​causality.method Base example AdverseEventCausalityMethod 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error AdverseEvent If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error AdverseEvent If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error AdverseEvent If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error AdverseEvent If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice AdverseEvent A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
nebenwirkung-grad3-art warning AdverseEvent Bei CTCAE-Schweregrad 3, 4 oder 5 muss die Art der Nebenwirkung (event.coding) angegeben sein. Bei Grad 1/2 darf sie fehlen (oBDS 15.2). seriousness.coding.where(system = 'https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-nebenwirkung-ctcae-grad' and (code = '3' or code = '4' or code = '5')).exists() implies event.coding.exists()

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AdverseEvent C 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
Constraints: nebenwirkung-grad3-art
... meta Σ 0..1 Meta Metadata about the resource
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:ctcaeVersion S 0..1 CodeableConcept CTCAE-Version
URL: https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-ex-onko-nebenwirkung-ctcae-version
Binding: MII VS Onkologie Nebenwirkung CTCAE-Version (required)
... actuality ?!Σ 1..1 code actual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
... event SΣ 1..1 CodeableConcept Type of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.
.... Slices for coding SΣ 0..* Coding Code defined by a terminology system
Slice: Unordered, Open by pattern:system
..... coding:All Slices Content/Rules for all slices
...... system SΣ 1..1 uri Identity of the terminology system
...... version SΣ 0..1 string CTCAE-Version
...... code SΣ 0..1 code Art der Nebenwirkung
..... coding:meddra SΣ 0..1 Coding Code defined by a terminology system
Binding: MII VS Onkologie Nebenwirkung nach CTCAE Art (required)
...... system SΣ 1..1 uri Identity of the terminology system
Required Pattern: https://www.meddra.org
...... version SΣ 0..1 string CTCAE-Version
...... code SΣ 1..1 code Art der Nebenwirkung
..... coding:snomed SΣ 0..1 Coding Art der Nebenwirkung (SNOMED CT)
...... system SΣ 1..1 uri Identity of the terminology system
Required Pattern: http://snomed.info/sct
...... version SΣ 0..1 string CTCAE-Version
...... code SΣ 1..1 code Art der Nebenwirkung
.... text SΣ 0..1 string Plain text representation of the concept
... subject SΣ 1..1 Reference(Patient) Subject impacted by event
... encounter SΣ 0..1 Reference(Encounter) Encounter created as part of
... seriousness SΣ 1..1 CodeableConcept Seriousness of the event
Binding: MII VS Onkologie Nebenwirkung nach CTCAE Grad (required)
.... coding SΣ 0..* Coding Schweregrad der Nebenwirkung nach CTCAE
..... system SΣ 1..1 uri Identity of the terminology system
..... code SΣ 1..1 code Symbol in syntax defined by the system
.... text SΣ 0..1 string Plain text representation of the concept
... suspectEntity SΣ 1..* BackboneElement The suspected agent causing the adverse event
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... instance SΣ 1..1 Reference(MII PR Onkologie Strahlentherapie | MII PR Onkologie Systemische Therapie | MII PR Onkologie Systemische Therapie Medikation) Refers to the specific entity that caused the adverse event

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
AdverseEvent.actuality Base required AdverseEventActuality 📍4.0.1 FHIR Std.
AdverseEvent.event Base example SNOMED CT Clinical Findings 📍4.0.1 FHIR Std.
AdverseEvent.event.coding:meddra Base required MII VS Onkologie Nebenwirkung nach CTCAE Art 📦2027.0.0-ballot.1 This IG
AdverseEvent.seriousness Base required MII VS Onkologie Nebenwirkung nach CTCAE Grad 📦2027.0.0-ballot.1 This IG

Constraints

Id Grade Path(s) Description Expression
dom-2 error AdverseEvent If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error AdverseEvent If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error AdverseEvent If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error AdverseEvent If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice AdverseEvent A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
nebenwirkung-grad3-art warning AdverseEvent Bei CTCAE-Schweregrad 3, 4 oder 5 muss die Art der Nebenwirkung (event.coding) angegeben sein. Bei Grad 1/2 darf sie fehlen (oBDS 15.2). seriousness.coding.where(system = 'https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-nebenwirkung-ctcae-grad' and (code = '3' or code = '4' or code = '5')).exists() implies event.coding.exists()

Differential View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AdverseEvent C 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
Constraints: nebenwirkung-grad3-art
... meta
.... profile S 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:ctcaeVersion S 0..1 CodeableConcept CTCAE-Version
URL: https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-ex-onko-nebenwirkung-ctcae-version
Binding: MII VS Onkologie Nebenwirkung CTCAE-Version (required)
... event S 1..1 CodeableConcept Type of the event itself in relation to the subject
.... Slices for coding S 0..* Coding Code defined by a terminology system
Slice: Unordered, Open by pattern:system
..... coding:All Slices Content/Rules for all slices
...... system S 1..1 uri Identity of the terminology system
...... version S 0..1 string CTCAE-Version
...... code S 0..1 code Art der Nebenwirkung
..... coding:meddra S 0..1 Coding Code defined by a terminology system
Binding: MII VS Onkologie Nebenwirkung nach CTCAE Art (required)
...... system S 1..1 uri Identity of the terminology system
Required Pattern: https://www.meddra.org
...... version S 0..1 string CTCAE-Version
...... code S 1..1 code Art der Nebenwirkung
..... coding:snomed S 0..1 Coding Art der Nebenwirkung (SNOMED CT)
...... system S 1..1 uri Identity of the terminology system
Required Pattern: http://snomed.info/sct
...... version S 0..1 string CTCAE-Version
...... code S 1..1 code Art der Nebenwirkung
.... text S 0..1 string Plain text representation of the concept
... encounter S 0..1 Reference(Encounter) Encounter created as part of
... seriousness S 1..1 CodeableConcept Seriousness of the event
Binding: MII VS Onkologie Nebenwirkung nach CTCAE Grad (required)
.... coding S 0..* Coding Schweregrad der Nebenwirkung nach CTCAE
..... system S 1..1 uri Identity of the terminology system
..... code S 1..1 code Symbol in syntax defined by the system
.... text S 0..1 string Plain text representation of the concept
... suspectEntity S 1..* BackboneElement The suspected agent causing the adverse event
.... instance S 1..1 Reference(MII PR Onkologie Strahlentherapie | MII PR Onkologie Systemische Therapie | MII PR Onkologie Systemische Therapie Medikation) Refers to the specific entity that caused the adverse event

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
AdverseEvent.event.coding:meddra Base required MII VS Onkologie Nebenwirkung nach CTCAE Art 📦2027.0.0-ballot.1 This IG
AdverseEvent.seriousness Base required MII VS Onkologie Nebenwirkung nach CTCAE Grad 📦2027.0.0-ballot.1 This IG

Constraints

Id Grade Path(s) Description Expression
nebenwirkung-grad3-art warning AdverseEvent Bei CTCAE-Schweregrad 3, 4 oder 5 muss die Art der Nebenwirkung (event.coding) angegeben sein. Bei Grad 1/2 darf sie fehlen (oBDS 15.2). seriousness.coding.where(system = 'https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-nebenwirkung-ctcae-grad' and (code = '3' or code = '4' or code = '5')).exists() implies event.coding.exists()

Snapshot ViewView

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AdverseEvent C 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
Constraints: nebenwirkung-grad3-art
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ 0..1 id Version specific identifier
.... lastUpdated Σ 0..1 instant When the resource version last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile SΣ 0..* canonical(StructureDefinition) Profiles this resource claims to conform to
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.
Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
This profile does not constrain the narrative in regard to content, language, or traceability to data elements
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:ctcaeVersion S 0..1 CodeableConcept CTCAE-Version
URL: https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/StructureDefinition/mii-ex-onko-nebenwirkung-ctcae-version
Binding: MII VS Onkologie Nebenwirkung CTCAE-Version (required)
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier Σ 0..1 Identifier Business identifier for the event
... actuality ?!Σ 1..1 code actual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
... category Σ 0..* CodeableConcept product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment
Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational.
... event SΣ 1..1 CodeableConcept Type of the event itself in relation to the subject
Binding: SNOMEDCTClinicalFindings (example): Detailed type of event.
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... Slices for coding SΣ 0..* Coding Code defined by a terminology system
Slice: Unordered, Open by pattern:system
..... coding:All Slices Content/Rules for all slices
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system SΣ 1..1 uri Identity of the terminology system
...... version SΣ 0..1 string CTCAE-Version
...... code SΣ 0..1 code Art der Nebenwirkung
...... display Σ 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... coding:meddra SΣ 0..1 Coding Code defined by a terminology system
Binding: MII VS Onkologie Nebenwirkung nach CTCAE Art (required)
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system SΣ 1..1 uri Identity of the terminology system
Required Pattern: https://www.meddra.org
...... version SΣ 0..1 string CTCAE-Version
...... code SΣ 1..1 code Art der Nebenwirkung
...... display Σ 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
..... coding:snomed SΣ 0..1 Coding Art der Nebenwirkung (SNOMED CT)
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system SΣ 1..1 uri Identity of the terminology system
Required Pattern: http://snomed.info/sct
...... version SΣ 0..1 string CTCAE-Version
...... code SΣ 1..1 code Art der Nebenwirkung
...... display Σ 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text SΣ 0..1 string Plain text representation of the concept
... subject SΣ 1..1 Reference(Patient) Subject impacted by event
... encounter SΣ 0..1 Reference(Encounter) Encounter created as part of
... date Σ 0..1 dateTime When the event occurred
... detected Σ 0..1 dateTime When the event was detected
... recordedDate Σ 0..1 dateTime When the event was recorded
... resultingCondition Σ 0..* Reference(Condition) Effect on the subject due to this event
... location Σ 0..1 Reference(Location) Location where adverse event occurred
... seriousness SΣ 1..1 CodeableConcept Seriousness of the event
Binding: MII VS Onkologie Nebenwirkung nach CTCAE Grad (required)
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... coding SΣ 0..* Coding Schweregrad der Nebenwirkung nach CTCAE
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... system SΣ 1..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code SΣ 1..1 code Symbol in syntax defined by the system
..... display Σ 0..1 string Representation defined by the system
..... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... text SΣ 0..1 string Plain text representation of the concept
... severity Σ 0..1 CodeableConcept mild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.
... outcome Σ 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).
... recorder Σ 0..1 Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) Who recorded the adverse event
... contributor Σ 0..* Reference(Practitioner | PractitionerRole | Device) Who was involved in the adverse event or the potential adverse event
... suspectEntity SΣ 1..* BackboneElement The suspected agent causing the adverse event
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... instance SΣ 1..1 Reference(MII PR Onkologie Strahlentherapie | MII PR Onkologie Systemische Therapie | MII PR Onkologie Systemische Therapie Medikation) Refers to the specific entity that caused the adverse event
.... causality Σ 0..* BackboneElement Information on the possible cause of the event
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... assessment Σ 0..1 CodeableConcept Assessment of if the entity caused the event
Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.
..... productRelatedness Σ 0..1 string AdverseEvent.suspectEntity.causalityProductRelatedness
..... author Σ 0..1 Reference(Practitioner | PractitionerRole) AdverseEvent.suspectEntity.causalityAuthor
..... method Σ 0..1 CodeableConcept ProbabilityScale | Bayesian | Checklist
Binding: AdverseEventCausalityMethod (example): TODO.
... subjectMedicalHistory Σ 0..* Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) AdverseEvent.subjectMedicalHistory
... referenceDocument Σ 0..* Reference(DocumentReference) AdverseEvent.referenceDocument
... study Σ 0..* Reference(ResearchStudy) AdverseEvent.study

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
AdverseEvent.meta.security Base extensible SecurityLabels 📍4.0.1 FHIR Std.
AdverseEvent.meta.tag Base example Common Tags 📍4.0.1 FHIR Std.
AdverseEvent.language Base preferred Common Languages 📍4.0.1 FHIR Std.
AdverseEvent.actuality Base required AdverseEventActuality 📍4.0.1 FHIR Std.
AdverseEvent.category Base extensible AdverseEventCategory 📍4.0.1 FHIR Std.
AdverseEvent.event Base example SNOMED CT Clinical Findings 📍4.0.1 FHIR Std.
AdverseEvent.event.coding:meddra Base required MII VS Onkologie Nebenwirkung nach CTCAE Art 📦2027.0.0-ballot.1 This IG
AdverseEvent.seriousness Base required MII VS Onkologie Nebenwirkung nach CTCAE Grad 📦2027.0.0-ballot.1 This IG
AdverseEvent.severity Base required AdverseEventSeverity 📍4.0.1 FHIR Std.
AdverseEvent.outcome Base required AdverseEventOutcome 📍4.0.1 FHIR Std.
AdverseEvent.suspectEntity.​causality.assessment Base example AdverseEventCausalityAssessment 📍4.0.1 FHIR Std.
AdverseEvent.suspectEntity.​causality.method Base example AdverseEventCausalityMethod 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
dom-2 error AdverseEvent If the resource is contained in another resource, it SHALL NOT contain nested Resources contained.contained.empty()
dom-3 error AdverseEvent If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4 error AdverseEvent If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5 error AdverseEvent If a resource is contained in another resource, it SHALL NOT have a security label contained.meta.security.empty()
dom-6 best practice AdverseEvent A resource should have narrative for robust management text.`div`.exists()
ele-1 error **ALL** elements All FHIR elements must have a @value or children hasValue() or (children().count() > id.count())
ext-1 error **ALL** extensions Must have either extensions or value[x], not both extension.exists() != value.exists()
nebenwirkung-grad3-art warning AdverseEvent Bei CTCAE-Schweregrad 3, 4 oder 5 muss die Art der Nebenwirkung (event.coding) angegeben sein. Bei Grad 1/2 darf sie fehlen (oBDS 15.2). seriousness.coding.where(system = 'https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/CodeSystem/mii-cs-onko-nebenwirkung-ctcae-grad' and (code = '3' or code = '4' or code = '5')).exists() implies event.coding.exists()

 

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