Kerndatensatz Senologie
0.9.0 - ci-build

Kerndatensatz Senologie - Local Development build (v0.9.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: BIH Senologie Nebenwirkung

Official URL: https://www.senologie.org/fhir/StructureDefinition/senologie-nebenwirkung Version: 0.9.0
Draft as of 2026-05-04 Computable Name: Senologie_Nebenwirkung

AdverseEvent für CTCAE-Nebenwirkungsgrading unter Systemtherapie. Erbt MedDRA-Kodierung und CTCAE-Grad von MII Onko Nebenwirkung.

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AdverseEvent 0..* MII_PR_Onko_Nebenwirkung_Adverse_Event Medical care, research study or other healthcare event causing physical injury
... 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
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
Slice: Unordered, Open by value:url
... event SΣ 1..1 CodeableConcept Nebenwirkungsart (MedDRA)
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
Binding: MII VS Onkologie Nebenwirkung nach CTCAE Art (required)
..... 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
...... system SΣ 1..1 uri Identity of the terminology system
Required Pattern: https://www.meddra.org
...... version SΣ 0..1 string Version of the system - if relevant
...... code SΣ 1..1 code Symbol in syntax defined by the system
.... text SΣ 0..1 string Plain text representation of the concept
... subject SΣC 1..1 Reference(Patient) Betroffene/r Patient/in
Constraints: ref-1
... encounter SΣC 0..1 Reference(Encounter) Encounter created as part of
Constraints: ref-1
... date SΣ 0..1 dateTime Zeitpunkt der Bewertung
... seriousness SΣ 1..1 CodeableConcept CTCAE-Grad (1-5, U, K)
Binding: MII VS Onkologie Nebenwirkung nach CTCAE Grad (required): Overall seriousness of this event for the patient.
.... 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 Auslösende Therapie
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... instance SΣC 1..1 Reference(Procedure | MedicationStatement) Referenz auf auslösende Systemtherapie-Procedure
Constraints: ref-1

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 Base required MII VS Onkologie Nebenwirkung nach CTCAE Art 📦2026.0.3 MII IG Onkologie v2026.0
AdverseEvent.seriousness Base required MII VS Onkologie Nebenwirkung nach CTCAE Grad 📦2026.0.3 MII IG Onkologie v2026.0

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()
ref-1 error AdverseEvent.subject, AdverseEvent.encounter, AdverseEvent.suspectEntity.instance SHALL have a contained resource if a local reference is provided reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))

This structure is derived from MII_PR_Onko_Nebenwirkung_Adverse_Event

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AdverseEvent 0..* MII_PR_Onko_Nebenwirkung_Adverse_Event Medical care, research study or other healthcare event causing physical injury
... actuality S 1..1 code actual | potential
Fixed Value: actual
... event 1..1 CodeableConcept Nebenwirkungsart (MedDRA)
... subject 1..1 Reference(Patient) Betroffene/r Patient/in
... seriousness 1..1 CodeableConcept CTCAE-Grad (1-5, U, K)
... suspectEntity 1..* BackboneElement Auslösende Therapie
.... instance 1..1 Reference(Procedure | MedicationStatement) Referenz auf auslösende Systemtherapie-Procedure

doco Documentation for this format
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AdverseEvent 0..* MII_PR_Onko_Nebenwirkung_Adverse_Event Medical care, research study or other healthcare event causing physical injury
... 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
... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
Slice: Unordered, Open by value:url
... identifier Σ 0..1 Identifier Business identifier for the event
... actuality ?!SΣ 1..1 code actual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
Fixed Value: actual
... 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 Nebenwirkungsart (MedDRA)
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
Binding: MII VS Onkologie Nebenwirkung nach CTCAE Art (required)
..... 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
...... 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 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
... subject SΣC 1..1 Reference(Patient) Betroffene/r Patient/in
Constraints: ref-1
... encounter SΣC 0..1 Reference(Encounter) Encounter created as part of
Constraints: ref-1
... date SΣ 0..1 dateTime Zeitpunkt der Bewertung
... detected Σ 0..1 dateTime When the event was detected
... recordedDate Σ 0..1 dateTime When the event was recorded
... resultingCondition ΣC 0..* Reference(Condition) Effect on the subject due to this event
Constraints: ref-1
... location ΣC 0..1 Reference(Location) Location where adverse event occurred
Constraints: ref-1
... seriousness SΣ 1..1 CodeableConcept CTCAE-Grad (1-5, U, K)
Binding: MII VS Onkologie Nebenwirkung nach CTCAE Grad (required): Overall seriousness of this event for the patient.
.... 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 ΣC 0..1 Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) Who recorded the adverse event
Constraints: ref-1
... contributor ΣC 0..* Reference(Practitioner | PractitionerRole | Device) Who was involved in the adverse event or the potential adverse event
Constraints: ref-1
... suspectEntity SΣ 1..* BackboneElement Auslösende Therapie
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... instance SΣC 1..1 Reference(Procedure | MedicationStatement) Referenz auf auslösende Systemtherapie-Procedure
Constraints: ref-1
.... 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
Slice: Unordered, Open by value:url
..... 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 ΣC 0..1 Reference(Practitioner | PractitionerRole) AdverseEvent.suspectEntity.causalityAuthor
Constraints: ref-1
..... method Σ 0..1 CodeableConcept ProbabilityScale | Bayesian | Checklist
Binding: AdverseEventCausalityMethod (example): TODO.
... subjectMedicalHistory ΣC 0..* Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) AdverseEvent.subjectMedicalHistory
Constraints: ref-1
... referenceDocument ΣC 0..* Reference(DocumentReference) AdverseEvent.referenceDocument
Constraints: ref-1
... study ΣC 0..* Reference(ResearchStudy) AdverseEvent.study
Constraints: ref-1

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 Base required MII VS Onkologie Nebenwirkung nach CTCAE Art 📦2026.0.3 MII IG Onkologie v2026.0
AdverseEvent.seriousness Base required MII VS Onkologie Nebenwirkung nach CTCAE Grad 📦2026.0.3 MII IG Onkologie v2026.0
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()
ref-1 error AdverseEvent.subject, AdverseEvent.encounter, AdverseEvent.resultingCondition, AdverseEvent.location, AdverseEvent.recorder, AdverseEvent.contributor, AdverseEvent.suspectEntity.instance, AdverseEvent.suspectEntity.causality.author, AdverseEvent.subjectMedicalHistory, AdverseEvent.referenceDocument, AdverseEvent.study SHALL have a contained resource if a local reference is provided reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))

This structure is derived from MII_PR_Onko_Nebenwirkung_Adverse_Event

Summary

Must-Support: 2 elements
Fixed: 1 element

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AdverseEvent 0..* MII_PR_Onko_Nebenwirkung_Adverse_Event Medical care, research study or other healthcare event causing physical injury
... 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
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
Slice: Unordered, Open by value:url
... event SΣ 1..1 CodeableConcept Nebenwirkungsart (MedDRA)
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
Binding: MII VS Onkologie Nebenwirkung nach CTCAE Art (required)
..... 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
...... system SΣ 1..1 uri Identity of the terminology system
Required Pattern: https://www.meddra.org
...... version SΣ 0..1 string Version of the system - if relevant
...... code SΣ 1..1 code Symbol in syntax defined by the system
.... text SΣ 0..1 string Plain text representation of the concept
... subject SΣC 1..1 Reference(Patient) Betroffene/r Patient/in
Constraints: ref-1
... encounter SΣC 0..1 Reference(Encounter) Encounter created as part of
Constraints: ref-1
... date SΣ 0..1 dateTime Zeitpunkt der Bewertung
... seriousness SΣ 1..1 CodeableConcept CTCAE-Grad (1-5, U, K)
Binding: MII VS Onkologie Nebenwirkung nach CTCAE Grad (required): Overall seriousness of this event for the patient.
.... 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 Auslösende Therapie
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... instance SΣC 1..1 Reference(Procedure | MedicationStatement) Referenz auf auslösende Systemtherapie-Procedure
Constraints: ref-1

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 Base required MII VS Onkologie Nebenwirkung nach CTCAE Art 📦2026.0.3 MII IG Onkologie v2026.0
AdverseEvent.seriousness Base required MII VS Onkologie Nebenwirkung nach CTCAE Grad 📦2026.0.3 MII IG Onkologie v2026.0

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()
ref-1 error AdverseEvent.subject, AdverseEvent.encounter, AdverseEvent.suspectEntity.instance SHALL have a contained resource if a local reference is provided reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))

Differential View

This structure is derived from MII_PR_Onko_Nebenwirkung_Adverse_Event

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AdverseEvent 0..* MII_PR_Onko_Nebenwirkung_Adverse_Event Medical care, research study or other healthcare event causing physical injury
... actuality S 1..1 code actual | potential
Fixed Value: actual
... event 1..1 CodeableConcept Nebenwirkungsart (MedDRA)
... subject 1..1 Reference(Patient) Betroffene/r Patient/in
... seriousness 1..1 CodeableConcept CTCAE-Grad (1-5, U, K)
... suspectEntity 1..* BackboneElement Auslösende Therapie
.... instance 1..1 Reference(Procedure | MedicationStatement) Referenz auf auslösende Systemtherapie-Procedure

doco Documentation for this format

Snapshot View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AdverseEvent 0..* MII_PR_Onko_Nebenwirkung_Adverse_Event Medical care, research study or other healthcare event causing physical injury
... 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
... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
Slice: Unordered, Open by value:url
... identifier Σ 0..1 Identifier Business identifier for the event
... actuality ?!SΣ 1..1 code actual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
Fixed Value: actual
... 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 Nebenwirkungsart (MedDRA)
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
Binding: MII VS Onkologie Nebenwirkung nach CTCAE Art (required)
..... 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
...... 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 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
... subject SΣC 1..1 Reference(Patient) Betroffene/r Patient/in
Constraints: ref-1
... encounter SΣC 0..1 Reference(Encounter) Encounter created as part of
Constraints: ref-1
... date SΣ 0..1 dateTime Zeitpunkt der Bewertung
... detected Σ 0..1 dateTime When the event was detected
... recordedDate Σ 0..1 dateTime When the event was recorded
... resultingCondition ΣC 0..* Reference(Condition) Effect on the subject due to this event
Constraints: ref-1
... location ΣC 0..1 Reference(Location) Location where adverse event occurred
Constraints: ref-1
... seriousness SΣ 1..1 CodeableConcept CTCAE-Grad (1-5, U, K)
Binding: MII VS Onkologie Nebenwirkung nach CTCAE Grad (required): Overall seriousness of this event for the patient.
.... 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 ΣC 0..1 Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) Who recorded the adverse event
Constraints: ref-1
... contributor ΣC 0..* Reference(Practitioner | PractitionerRole | Device) Who was involved in the adverse event or the potential adverse event
Constraints: ref-1
... suspectEntity SΣ 1..* BackboneElement Auslösende Therapie
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... instance SΣC 1..1 Reference(Procedure | MedicationStatement) Referenz auf auslösende Systemtherapie-Procedure
Constraints: ref-1
.... 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
Slice: Unordered, Open by value:url
..... 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 ΣC 0..1 Reference(Practitioner | PractitionerRole) AdverseEvent.suspectEntity.causalityAuthor
Constraints: ref-1
..... method Σ 0..1 CodeableConcept ProbabilityScale | Bayesian | Checklist
Binding: AdverseEventCausalityMethod (example): TODO.
... subjectMedicalHistory ΣC 0..* Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) AdverseEvent.subjectMedicalHistory
Constraints: ref-1
... referenceDocument ΣC 0..* Reference(DocumentReference) AdverseEvent.referenceDocument
Constraints: ref-1
... study ΣC 0..* Reference(ResearchStudy) AdverseEvent.study
Constraints: ref-1

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 Base required MII VS Onkologie Nebenwirkung nach CTCAE Art 📦2026.0.3 MII IG Onkologie v2026.0
AdverseEvent.seriousness Base required MII VS Onkologie Nebenwirkung nach CTCAE Grad 📦2026.0.3 MII IG Onkologie v2026.0
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()
ref-1 error AdverseEvent.subject, AdverseEvent.encounter, AdverseEvent.resultingCondition, AdverseEvent.location, AdverseEvent.recorder, AdverseEvent.contributor, AdverseEvent.suspectEntity.instance, AdverseEvent.suspectEntity.causality.author, AdverseEvent.subjectMedicalHistory, AdverseEvent.referenceDocument, AdverseEvent.study SHALL have a contained resource if a local reference is provided reference.startsWith('#').not() or (reference.substring(1).trace('url') in %rootResource.contained.id.trace('ids'))

This structure is derived from MII_PR_Onko_Nebenwirkung_Adverse_Event

Summary

Must-Support: 2 elements
Fixed: 1 element

 

Other representations of profile: CSV, Excel, Schematron