FHIR Osiris Implementation Guide
2.1.0 - ci-build

FHIR Osiris Implementation Guide - Local Development build (v2.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: Oncologic Adverse Event

Official URL: https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/StructureDefinition/onco-adverse-event Version: 2.1.0
Draft as of 2024-03-21 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.

This structure is derived from AdverseEvent

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..*AdverseEventMedical care, research study or other healthcare event causing physical injury
... end-date S0..1dateTimeEnd date
URL: https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/StructureDefinition/adverse-event-end-date
... event 1..1CodeableConceptTerm to describe the adverse event
Binding: Adverse Event Code Value Set (extensible)
... subject S1..1Reference(Oncology Patient)Subject impacted by event
... seriousness S1..1CodeableConceptGrade of the adverse event
Binding: Adverse Event Grade Value Set (required)
.... coding
..... code 0..1codeSymbol in syntax defined by the system
... suspectEntity
.... instance S1..1Reference(Oncology-related Medication Statement)Refers to the specific entity that caused the adverse event
... subjectMedicalHistory S0..*Reference(Tumor Pathology Event)AdverseEvent.subjectMedicalHistory

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
AdverseEvent.eventextensibleAdverseEventCode
https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/AdverseEventCode
from this IG
AdverseEvent.seriousnessrequiredAdverseEventGrade
https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/AdverseEventGrade
from this IG
NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..*AdverseEventMedical care, research study or other healthcare event causing physical injury
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... end-date S0..1dateTimeEnd date
URL: https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/StructureDefinition/adverse-event-end-date
... modifierExtension ?!N0..*ExtensionExtensions that cannot be ignored
Slice: Unordered, Open by value:url
... event Σ1..1CodeableConceptTerm to describe the adverse event
Binding: Adverse Event Code Value Set (extensible)
... subject SΣC1..1Reference(Oncology Patient)Subject impacted by event
ref-1: SHALL have a contained resource if a local reference is provided
... date SΣ1..1dateTimeDate of diagnosis
... seriousness SΣ1..1CodeableConceptGrade of the adverse event
Binding: Adverse Event Grade Value Set (required)
... suspectEntity Σ0..*BackboneElementThe suspected agent causing the adverse event
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... instance SΣC1..1Reference(Oncology-related Medication Statement)Refers to the specific entity that caused the adverse event
ref-1: SHALL have a contained resource if a local reference is provided
... subjectMedicalHistory SΣC0..*Reference(Tumor Pathology Event)AdverseEvent.subjectMedicalHistory
ref-1: SHALL have a contained resource if a local reference is provided

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
AdverseEvent.actualityrequiredAdverseEventActuality
http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
from the FHIR Standard
AdverseEvent.eventextensibleAdverseEventCode
https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/AdverseEventCode
from this IG
AdverseEvent.seriousnessrequiredAdverseEventGrade
https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/AdverseEventGrade
from this IG
NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..*AdverseEventMedical care, research study or other healthcare event causing physical injury
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguagesMax Binding
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... Slices for extension N0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
... end-date S0..1dateTimeEnd date
URL: https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/StructureDefinition/adverse-event-end-date
... modifierExtension ?!N0..*ExtensionExtensions that cannot be ignored
Slice: Unordered, Open by value:url
... identifier Σ0..1IdentifierBusiness identifier for the event
... actuality ?!Σ1..1codeactual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.

... category Σ0..*CodeableConceptproduct-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 Σ1..1CodeableConceptTerm to describe the adverse event
Binding: Adverse Event Code Value Set (extensible)
... subject SΣC1..1Reference(Oncology Patient)Subject impacted by event
ref-1: SHALL have a contained resource if a local reference is provided
... encounter ΣC0..1Reference(Encounter)Encounter created as part of
ref-1: SHALL have a contained resource if a local reference is provided
... date SΣ1..1dateTimeDate of diagnosis
... detected Σ0..1dateTimeWhen the event was detected
... recordedDate Σ0..1dateTimeWhen the event was recorded
... resultingCondition ΣC0..*Reference(Condition)Effect on the subject due to this event
ref-1: SHALL have a contained resource if a local reference is provided
... location ΣC0..1Reference(Location)Location where adverse event occurred
ref-1: SHALL have a contained resource if a local reference is provided
... seriousness SΣ1..1CodeableConceptGrade of the adverse event
Binding: Adverse Event Grade Value Set (required)
.... id 0..1stringUnique id for inter-element referencing
.... extension N0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ0..*CodingCode defined by a terminology system
..... id 0..1stringUnique id for inter-element referencing
..... extension N0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ0..1uriIdentity of the terminology system
..... version Σ0..1stringVersion of the system - if relevant
..... code Σ0..1codeSymbol in syntax defined by the system
..... display Σ0..1stringRepresentation defined by the system
..... userSelected Σ0..1booleanIf this coding was chosen directly by the user
.... text Σ0..1stringPlain text representation of the concept
... severity Σ0..1CodeableConceptmild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.

... outcome Σ0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).

... recorder ΣC0..1Reference(Patient | Practitioner | PractitionerRole | RelatedPerson)Who recorded the adverse event
ref-1: SHALL have a contained resource if a local reference is provided
... contributor ΣC0..*Reference(Practitioner | PractitionerRole | Device)Who was involved in the adverse event or the potential adverse event
ref-1: SHALL have a contained resource if a local reference is provided
... suspectEntity Σ0..*BackboneElementThe suspected agent causing the adverse event
.... id 0..1stringUnique id for inter-element referencing
.... extension N0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... instance SΣC1..1Reference(Oncology-related Medication Statement)Refers to the specific entity that caused the adverse event
ref-1: SHALL have a contained resource if a local reference is provided
.... causality Σ0..*BackboneElementInformation on the possible cause of the event
..... id 0..1stringUnique id for inter-element referencing
..... extension N0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... assessment Σ0..1CodeableConceptAssessment of if the entity caused the event
Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.

..... productRelatedness Σ0..1stringAdverseEvent.suspectEntity.causalityProductRelatedness
..... author ΣC0..1Reference(Practitioner | PractitionerRole)AdverseEvent.suspectEntity.causalityAuthor
ref-1: SHALL have a contained resource if a local reference is provided
..... method Σ0..1CodeableConceptProbabilityScale | Bayesian | Checklist
Binding: AdverseEventCausalityMethod (example): TODO.

... subjectMedicalHistory SΣC0..*Reference(Tumor Pathology Event)AdverseEvent.subjectMedicalHistory
ref-1: SHALL have a contained resource if a local reference is provided
... referenceDocument ΣC0..*Reference(DocumentReference)AdverseEvent.referenceDocument
ref-1: SHALL have a contained resource if a local reference is provided
... study ΣC0..*Reference(ResearchStudy)AdverseEvent.study
ref-1: SHALL have a contained resource if a local reference is provided

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
AdverseEvent.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
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://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/AdverseEventCode
from this IG
AdverseEvent.seriousnessrequiredAdverseEventGrade
https://build.fhir.org/ig/arkhn/arkhn-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

Differential View

This structure is derived from AdverseEvent

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..*AdverseEventMedical care, research study or other healthcare event causing physical injury
... end-date S0..1dateTimeEnd date
URL: https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/StructureDefinition/adverse-event-end-date
... event 1..1CodeableConceptTerm to describe the adverse event
Binding: Adverse Event Code Value Set (extensible)
... subject S1..1Reference(Oncology Patient)Subject impacted by event
... seriousness S1..1CodeableConceptGrade of the adverse event
Binding: Adverse Event Grade Value Set (required)
.... coding
..... code 0..1codeSymbol in syntax defined by the system
... suspectEntity
.... instance S1..1Reference(Oncology-related Medication Statement)Refers to the specific entity that caused the adverse event
... subjectMedicalHistory S0..*Reference(Tumor Pathology Event)AdverseEvent.subjectMedicalHistory

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
AdverseEvent.eventextensibleAdverseEventCode
https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/AdverseEventCode
from this IG
AdverseEvent.seriousnessrequiredAdverseEventGrade
https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/AdverseEventGrade
from this IG

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..*AdverseEventMedical care, research study or other healthcare event causing physical injury
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... end-date S0..1dateTimeEnd date
URL: https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/StructureDefinition/adverse-event-end-date
... modifierExtension ?!N0..*ExtensionExtensions that cannot be ignored
Slice: Unordered, Open by value:url
... event Σ1..1CodeableConceptTerm to describe the adverse event
Binding: Adverse Event Code Value Set (extensible)
... subject SΣC1..1Reference(Oncology Patient)Subject impacted by event
ref-1: SHALL have a contained resource if a local reference is provided
... date SΣ1..1dateTimeDate of diagnosis
... seriousness SΣ1..1CodeableConceptGrade of the adverse event
Binding: Adverse Event Grade Value Set (required)
... suspectEntity Σ0..*BackboneElementThe suspected agent causing the adverse event
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... instance SΣC1..1Reference(Oncology-related Medication Statement)Refers to the specific entity that caused the adverse event
ref-1: SHALL have a contained resource if a local reference is provided
... subjectMedicalHistory SΣC0..*Reference(Tumor Pathology Event)AdverseEvent.subjectMedicalHistory
ref-1: SHALL have a contained resource if a local reference is provided

doco Documentation for this format

Terminology Bindings

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

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..*AdverseEventMedical care, research study or other healthcare event causing physical injury
... id Σ0..1idLogical id of this artifact
... meta Σ0..1MetaMetadata about the resource
... implicitRules ?!Σ0..1uriA set of rules under which this content was created
... language 0..1codeLanguage of the resource content
Binding: CommonLanguages (preferred): A human language.

Additional BindingsPurpose
AllLanguagesMax Binding
... text 0..1NarrativeText summary of the resource, for human interpretation
... contained 0..*ResourceContained, inline Resources
... Slices for extension N0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
... end-date S0..1dateTimeEnd date
URL: https://build.fhir.org/ig/arkhn/arkhn-ig-osiris/StructureDefinition/adverse-event-end-date
... modifierExtension ?!N0..*ExtensionExtensions that cannot be ignored
Slice: Unordered, Open by value:url
... identifier Σ0..1IdentifierBusiness identifier for the event
... actuality ?!Σ1..1codeactual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.

... category Σ0..*CodeableConceptproduct-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 Σ1..1CodeableConceptTerm to describe the adverse event
Binding: Adverse Event Code Value Set (extensible)
... subject SΣC1..1Reference(Oncology Patient)Subject impacted by event
ref-1: SHALL have a contained resource if a local reference is provided
... encounter ΣC0..1Reference(Encounter)Encounter created as part of
ref-1: SHALL have a contained resource if a local reference is provided
... date SΣ1..1dateTimeDate of diagnosis
... detected Σ0..1dateTimeWhen the event was detected
... recordedDate Σ0..1dateTimeWhen the event was recorded
... resultingCondition ΣC0..*Reference(Condition)Effect on the subject due to this event
ref-1: SHALL have a contained resource if a local reference is provided
... location ΣC0..1Reference(Location)Location where adverse event occurred
ref-1: SHALL have a contained resource if a local reference is provided
... seriousness SΣ1..1CodeableConceptGrade of the adverse event
Binding: Adverse Event Grade Value Set (required)
.... id 0..1stringUnique id for inter-element referencing
.... extension N0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ0..*CodingCode defined by a terminology system
..... id 0..1stringUnique id for inter-element referencing
..... extension N0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... system Σ0..1uriIdentity of the terminology system
..... version Σ0..1stringVersion of the system - if relevant
..... code Σ0..1codeSymbol in syntax defined by the system
..... display Σ0..1stringRepresentation defined by the system
..... userSelected Σ0..1booleanIf this coding was chosen directly by the user
.... text Σ0..1stringPlain text representation of the concept
... severity Σ0..1CodeableConceptmild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.

... outcome Σ0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).

... recorder ΣC0..1Reference(Patient | Practitioner | PractitionerRole | RelatedPerson)Who recorded the adverse event
ref-1: SHALL have a contained resource if a local reference is provided
... contributor ΣC0..*Reference(Practitioner | PractitionerRole | Device)Who was involved in the adverse event or the potential adverse event
ref-1: SHALL have a contained resource if a local reference is provided
... suspectEntity Σ0..*BackboneElementThe suspected agent causing the adverse event
.... id 0..1stringUnique id for inter-element referencing
.... extension N0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... instance SΣC1..1Reference(Oncology-related Medication Statement)Refers to the specific entity that caused the adverse event
ref-1: SHALL have a contained resource if a local reference is provided
.... causality Σ0..*BackboneElementInformation on the possible cause of the event
..... id 0..1stringUnique id for inter-element referencing
..... extension N0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
..... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
..... assessment Σ0..1CodeableConceptAssessment of if the entity caused the event
Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.

..... productRelatedness Σ0..1stringAdverseEvent.suspectEntity.causalityProductRelatedness
..... author ΣC0..1Reference(Practitioner | PractitionerRole)AdverseEvent.suspectEntity.causalityAuthor
ref-1: SHALL have a contained resource if a local reference is provided
..... method Σ0..1CodeableConceptProbabilityScale | Bayesian | Checklist
Binding: AdverseEventCausalityMethod (example): TODO.

... subjectMedicalHistory SΣC0..*Reference(Tumor Pathology Event)AdverseEvent.subjectMedicalHistory
ref-1: SHALL have a contained resource if a local reference is provided
... referenceDocument ΣC0..*Reference(DocumentReference)AdverseEvent.referenceDocument
ref-1: SHALL have a contained resource if a local reference is provided
... study ΣC0..*Reference(ResearchStudy)AdverseEvent.study
ref-1: SHALL have a contained resource if a local reference is provided

doco Documentation for this format

Terminology Bindings

PathConformanceValueSetURI
AdverseEvent.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
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://build.fhir.org/ig/arkhn/arkhn-ig-osiris/ValueSet/AdverseEventCode
from this IG
AdverseEvent.seriousnessrequiredAdverseEventGrade
https://build.fhir.org/ig/arkhn/arkhn-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