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FHIR Osiris Implementation Guide
1.1.0 - trial-implementation

This page is part of the OSIRIS FHIR Implementation Guide (v1.1.0: 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: Oncologic Adverse Event

Official URL: https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/onco-adverse-event Version: 1.1.0
Draft as of 2025-04-03 Computable Name: OncoAdverseEvent

Adverse event related to a cancer-related treatment associated to a grade from MEDDRA terminology (ex: 10047700: "Vomiting").

Usage:

Formal Views of Profile Content

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

NomDrapeauxCard.TypeDescription et contraintesdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
dom-3: 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
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
dom-6: A resource should have narrative for robust management
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
ele-1: All FHIR elements must have a @value or children
... Slices pour extension 0..* Extension Extension
Slice: Unordered, Open by value:url
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... extension:end-date S 0..1 dateTime End date
URL: https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/adverse-event-end-date
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
... event Σ 1..1 CodeableConcept Term to describe the adverse event
Binding: Adverse Event Code Value Set (extensible)
ele-1: All FHIR elements must have a @value or children
... subject SΣ 1..1 Reference(Oncology Patient) Subject impacted by event
ele-1: All FHIR elements must have a @value or children
... date SΣ 1..1 dateTime Date of diagnosis
ele-1: All FHIR elements must have a @value or children
... seriousness SΣ 1..1 CodeableConcept Grade of the adverse event
Binding: Adverse Event Grade Value Set (required)
ele-1: All FHIR elements must have a @value or children
... suspectEntity Σ 0..* BackboneElement The suspected agent causing the adverse event
ele-1: All FHIR elements must have a @value or children
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... instance SΣ 1..1 Reference(Oncology-related Medication Statement) Refers to the specific entity that caused the adverse event
ele-1: All FHIR elements must have a @value or children
... subjectMedicalHistory SΣ 0..* Reference(Tumor Pathology Event) AdverseEvent.subjectMedicalHistory
ele-1: All FHIR elements must have a @value or children

doco Documentation for this format

Terminology Bindings

PathConformitéValueSetURI
AdverseEvent.actualityrequiredAdverseEventActuality
http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
from the FHIR Standard
AdverseEvent.eventextensibleAdverseEventCode
https://ig-osiris.cancer.fr/ig/osiris/ValueSet/AdverseEventCode
from this IG
AdverseEvent.seriousnessrequiredAdverseEventGrade
https://ig-osiris.cancer.fr/ig/osiris/ValueSet/AdverseEventGrade
from this IG

This structure is derived from AdverseEvent

NomDrapeauxCard.TypeDescription et contraintesdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... Slices pour extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:end-date S 0..1 dateTime End date
URL: https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/adverse-event-end-date
... event 1..1 CodeableConcept Term to describe the adverse event
Binding: Adverse Event Code Value Set (extensible)
... subject S 1..1 Reference(Oncology Patient) Subject impacted by event
... seriousness S 1..1 CodeableConcept Grade of the adverse event
Binding: Adverse Event Grade Value Set (required)
.... coding
..... code 0..1 code Symbol in syntax defined by the system
... suspectEntity
.... instance S 1..1 Reference(Oncology-related Medication Statement) Refers to the specific entity that caused the adverse event
... subjectMedicalHistory S 0..* Reference(Tumor Pathology Event) AdverseEvent.subjectMedicalHistory

doco Documentation for this format

Terminology Bindings (Differential)

PathConformitéValueSetURI
AdverseEvent.eventextensibleAdverseEventCode
https://ig-osiris.cancer.fr/ig/osiris/ValueSet/AdverseEventCode
from this IG
AdverseEvent.seriousnessrequiredAdverseEventGrade
https://ig-osiris.cancer.fr/ig/osiris/ValueSet/AdverseEventGrade
from this IG
NomDrapeauxCard.TypeDescription et contraintesdoco
.. AdverseEvent 0..* AdverseEvent 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
... 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.

Bindings AdditionnelsBut
AllLanguages Binding Max
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... Slices pour extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:end-date S 0..1 dateTime End date
URL: https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/adverse-event-end-date
... 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 Σ 1..1 CodeableConcept Term to describe the adverse event
Binding: Adverse Event Code Value Set (extensible)
... subject SΣ 1..1 Reference(Oncology Patient) Subject impacted by event
... encounter Σ 0..1 Reference(Encounter) Encounter created as part of
... date SΣ 1..1 dateTime Date of diagnosis
... 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 Grade of the adverse event
Binding: Adverse Event Grade Value Set (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 Σ 0..* 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 Σ 0..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code Σ 0..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 Σ 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 Σ 0..* 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(Oncology-related Medication Statement) 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 SΣ 0..* Reference(Tumor Pathology Event) AdverseEvent.subjectMedicalHistory
... referenceDocument Σ 0..* Reference(DocumentReference) AdverseEvent.referenceDocument
... study Σ 0..* Reference(ResearchStudy) AdverseEvent.study

doco Documentation for this format

Terminology Bindings

PathConformitéValueSetURI
AdverseEvent.languagepreferredCommonLanguages
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
Bindings Additionnels But
AllLanguages Binding Max
AdverseEvent.actualityrequiredAdverseEventActuality
http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
from the FHIR Standard
AdverseEvent.categoryextensibleAdverseEventCategory
http://hl7.org/fhir/ValueSet/adverse-event-category
from the FHIR Standard
AdverseEvent.eventextensibleAdverseEventCode
https://ig-osiris.cancer.fr/ig/osiris/ValueSet/AdverseEventCode
from this IG
AdverseEvent.seriousnessrequiredAdverseEventGrade
https://ig-osiris.cancer.fr/ig/osiris/ValueSet/AdverseEventGrade
from this IG
AdverseEvent.severityrequiredAdverseEventSeverity
http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1
from the FHIR Standard
AdverseEvent.outcomerequiredAdverseEventOutcome
http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1
from the FHIR Standard
AdverseEvent.suspectEntity.causality.assessmentexampleAdverseEventCausalityAssessment
http://hl7.org/fhir/ValueSet/adverse-event-causality-assess
from the FHIR Standard
AdverseEvent.suspectEntity.causality.methodexampleAdverseEventCausalityMethod
http://hl7.org/fhir/ValueSet/adverse-event-causality-method
from the FHIR Standard

Key Elements View

NomDrapeauxCard.TypeDescription et contraintesdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
dom-3: 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
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
dom-6: A resource should have narrative for robust management
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
ele-1: All FHIR elements must have a @value or children
... Slices pour extension 0..* Extension Extension
Slice: Unordered, Open by value:url
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... extension:end-date S 0..1 dateTime End date
URL: https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/adverse-event-end-date
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
... event Σ 1..1 CodeableConcept Term to describe the adverse event
Binding: Adverse Event Code Value Set (extensible)
ele-1: All FHIR elements must have a @value or children
... subject SΣ 1..1 Reference(Oncology Patient) Subject impacted by event
ele-1: All FHIR elements must have a @value or children
... date SΣ 1..1 dateTime Date of diagnosis
ele-1: All FHIR elements must have a @value or children
... seriousness SΣ 1..1 CodeableConcept Grade of the adverse event
Binding: Adverse Event Grade Value Set (required)
ele-1: All FHIR elements must have a @value or children
... suspectEntity Σ 0..* BackboneElement The suspected agent causing the adverse event
ele-1: All FHIR elements must have a @value or children
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... instance SΣ 1..1 Reference(Oncology-related Medication Statement) Refers to the specific entity that caused the adverse event
ele-1: All FHIR elements must have a @value or children
... subjectMedicalHistory SΣ 0..* Reference(Tumor Pathology Event) AdverseEvent.subjectMedicalHistory
ele-1: All FHIR elements must have a @value or children

doco Documentation for this format

Terminology Bindings

PathConformitéValueSetURI
AdverseEvent.actualityrequiredAdverseEventActuality
http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
from the FHIR Standard
AdverseEvent.eventextensibleAdverseEventCode
https://ig-osiris.cancer.fr/ig/osiris/ValueSet/AdverseEventCode
from this IG
AdverseEvent.seriousnessrequiredAdverseEventGrade
https://ig-osiris.cancer.fr/ig/osiris/ValueSet/AdverseEventGrade
from this IG

Differential View

This structure is derived from AdverseEvent

NomDrapeauxCard.TypeDescription et contraintesdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... Slices pour extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:end-date S 0..1 dateTime End date
URL: https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/adverse-event-end-date
... event 1..1 CodeableConcept Term to describe the adverse event
Binding: Adverse Event Code Value Set (extensible)
... subject S 1..1 Reference(Oncology Patient) Subject impacted by event
... seriousness S 1..1 CodeableConcept Grade of the adverse event
Binding: Adverse Event Grade Value Set (required)
.... coding
..... code 0..1 code Symbol in syntax defined by the system
... suspectEntity
.... instance S 1..1 Reference(Oncology-related Medication Statement) Refers to the specific entity that caused the adverse event
... subjectMedicalHistory S 0..* Reference(Tumor Pathology Event) AdverseEvent.subjectMedicalHistory

doco Documentation for this format

Terminology Bindings (Differential)

PathConformitéValueSetURI
AdverseEvent.eventextensibleAdverseEventCode
https://ig-osiris.cancer.fr/ig/osiris/ValueSet/AdverseEventCode
from this IG
AdverseEvent.seriousnessrequiredAdverseEventGrade
https://ig-osiris.cancer.fr/ig/osiris/ValueSet/AdverseEventGrade
from this IG

Snapshot View

NomDrapeauxCard.TypeDescription et contraintesdoco
.. AdverseEvent 0..* AdverseEvent 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
... 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.

Bindings AdditionnelsBut
AllLanguages Binding Max
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... Slices pour extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:end-date S 0..1 dateTime End date
URL: https://ig-osiris.cancer.fr/ig/osiris/StructureDefinition/adverse-event-end-date
... 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 Σ 1..1 CodeableConcept Term to describe the adverse event
Binding: Adverse Event Code Value Set (extensible)
... subject SΣ 1..1 Reference(Oncology Patient) Subject impacted by event
... encounter Σ 0..1 Reference(Encounter) Encounter created as part of
... date SΣ 1..1 dateTime Date of diagnosis
... 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 Grade of the adverse event
Binding: Adverse Event Grade Value Set (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 Σ 0..* 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 Σ 0..1 uri Identity of the terminology system
..... version Σ 0..1 string Version of the system - if relevant
..... code Σ 0..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 Σ 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 Σ 0..* 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(Oncology-related Medication Statement) 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 SΣ 0..* Reference(Tumor Pathology Event) AdverseEvent.subjectMedicalHistory
... referenceDocument Σ 0..* Reference(DocumentReference) AdverseEvent.referenceDocument
... study Σ 0..* Reference(ResearchStudy) AdverseEvent.study

doco Documentation for this format

Terminology Bindings

PathConformitéValueSetURI
AdverseEvent.languagepreferredCommonLanguages
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
Bindings Additionnels But
AllLanguages Binding Max
AdverseEvent.actualityrequiredAdverseEventActuality
http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
from the FHIR Standard
AdverseEvent.categoryextensibleAdverseEventCategory
http://hl7.org/fhir/ValueSet/adverse-event-category
from the FHIR Standard
AdverseEvent.eventextensibleAdverseEventCode
https://ig-osiris.cancer.fr/ig/osiris/ValueSet/AdverseEventCode
from this IG
AdverseEvent.seriousnessrequiredAdverseEventGrade
https://ig-osiris.cancer.fr/ig/osiris/ValueSet/AdverseEventGrade
from this IG
AdverseEvent.severityrequiredAdverseEventSeverity
http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1
from the FHIR Standard
AdverseEvent.outcomerequiredAdverseEventOutcome
http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1
from the FHIR Standard
AdverseEvent.suspectEntity.causality.assessmentexampleAdverseEventCausalityAssessment
http://hl7.org/fhir/ValueSet/adverse-event-causality-assess
from the FHIR Standard
AdverseEvent.suspectEntity.causality.methodexampleAdverseEventCausalityMethod
http://hl7.org/fhir/ValueSet/adverse-event-causality-method
from the FHIR Standard

 

Other representations of profile: CSV, Excel, Schematron