CodeX Radiation Therapy
1.0.0 - STU 1 United States of America flag

This page is part of the CodeX™ Radiation Therapy (v1.0.0: STU 1) based on FHIR R4. This is the current published version. For a full list of available versions, see the Directory of published versions

Resource Profile: Radiotherapy Adverse Event ( Experimental )

Official URL: http://hl7.org/fhir/us/codex-radiation-therapy/StructureDefinition/codexrt-radiotherapy-adverse-event Version: 1.0.0
Draft as of 2023-07-28 Computable Name: RadiotherapyAdverseEvent

A Radiotherapy Adverse Event is an adverse event resulting from radiation toxicity. This profile is based on the work of the Vulcan project. Future versions of this IG should reference adverse event profiles from Vulcan, once they are published. The current profile is inspired by the work of Vulcan and Common Terminology Criteria (CTC) Adverse Event (CTCAE).

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
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... severity-or-grade S0..1CodeableConceptRadiotherapy Adverse Event Grade
URL: http://hl7.org/fhir/us/codex-radiation-therapy/StructureDefinition/codexrt-radiotheraphy-adverse-event-severity-or-grade
Binding: Adverse Event Severity or Grade Value Set (required)
... actuality S1..1codeactual | potential
Required Pattern: actual
.... coding 1..*CodingCode defined by a terminology system
.... text S0..1stringVerbatim Text
... subject S1..1Reference(US Core Patient Profile)Subject impacted by event
... encounter S0..1Reference(Encounter)Encounter created as part of
... date S0..1dateTimeWhen the event occurred
... outcome S0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
... recorder S0..1Reference(Patient | Practitioner | PractitionerRole | RelatedPerson)Who recorded the adverse event
... suspectEntity S0..*BackboneElementThe suspected agent causing the adverse event
.... instance 1..1Reference(Radiotherapy Treated Phase | Radiotherapy Course Summary | Radiotherapy Treated Plan)Refers to the specific entity that caused the adverse event

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet
AdverseEvent.eventpreferredAdverseEventTermVS
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
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... severity-or-grade S0..1CodeableConceptRadiotherapy Adverse Event Grade
URL: http://hl7.org/fhir/us/codex-radiation-therapy/StructureDefinition/codexrt-radiotheraphy-adverse-event-severity-or-grade
Binding: Adverse Event Severity or Grade Value Set (required)
... actuality ?!SΣ1..1codeactual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.


Required Pattern: actual
... event SΣ1..1CodeableConceptAdverse Event Term
Binding: Adverse Event Terms Value Set (preferred)
.... coding Σ1..*CodingCode defined by a terminology system
.... text SΣ0..1stringVerbatim Text
... subject SΣ1..1Reference(US Core Patient Profile)Subject impacted by event
... encounter SΣ0..1Reference(Encounter)Encounter created as part of
... date SΣ0..1dateTimeWhen the event occurred
... outcome SΣ0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).

... recorder SΣ0..1Reference(Patient | Practitioner | PractitionerRole | RelatedPerson)Who recorded the adverse event
... suspectEntity SΣ0..*BackboneElementThe suspected agent causing the adverse event
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... instance Σ1..1Reference(Radiotherapy Treated Phase | Radiotherapy Course Summary | Radiotherapy Treated Plan)Refers to the specific entity that caused the adverse event

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
AdverseEvent.actualityrequiredPattern: actual
AdverseEvent.eventpreferredAdverseEventTermVS
AdverseEvent.outcomerequiredAdverseEventOutcome
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 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... severity-or-grade S0..1CodeableConceptRadiotherapy Adverse Event Grade
URL: http://hl7.org/fhir/us/codex-radiation-therapy/StructureDefinition/codexrt-radiotheraphy-adverse-event-severity-or-grade
Binding: Adverse Event Severity or Grade Value Set (required)
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..1IdentifierBusiness identifier for the event
... actuality ?!SΣ1..1codeactual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.


Required Pattern: actual
... 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 SΣ1..1CodeableConceptAdverse Event Term
Binding: Adverse Event Terms Value Set (preferred)
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ1..*CodingCode defined by a terminology system
.... text SΣ0..1stringVerbatim Text
... subject SΣ1..1Reference(US Core Patient Profile)Subject impacted by event
... encounter SΣ0..1Reference(Encounter)Encounter created as part of
... date SΣ0..1dateTimeWhen the event occurred
... detected Σ0..1dateTimeWhen the event was detected
... recordedDate Σ0..1dateTimeWhen the event was recorded
... resultingCondition Σ0..*Reference(Condition)Effect on the subject due to this event
... location Σ0..1Reference(Location)Location where adverse event occurred
... seriousness Σ0..1CodeableConceptSeriousness of the event
Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.

... severity Σ0..1CodeableConceptmild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.

... outcome SΣ0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).

... recorder SΣ0..1Reference(Patient | Practitioner | PractitionerRole | RelatedPerson)Who recorded the adverse event
... contributor Σ0..*Reference(Practitioner | PractitionerRole | Device)Who was involved in the adverse event or the potential adverse event
... suspectEntity SΣ0..*BackboneElementThe suspected agent causing the adverse event
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... instance Σ1..1Reference(Radiotherapy Treated Phase | Radiotherapy Course Summary | Radiotherapy Treated Plan)Refers to the specific entity that caused the adverse event
.... causality Σ0..*BackboneElementInformation on the possible cause of the event
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... 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 Σ0..1Reference(Practitioner | PractitionerRole)AdverseEvent.suspectEntity.causalityAuthor
..... method Σ0..1CodeableConceptProbabilityScale | Bayesian | Checklist
Binding: AdverseEventCausalityMethod (example): TODO.

... subjectMedicalHistory Σ0..*Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference)AdverseEvent.subjectMedicalHistory
... referenceDocument Σ0..*Reference(DocumentReference)AdverseEvent.referenceDocument
... study Σ0..*Reference(ResearchStudy)AdverseEvent.study

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
AdverseEvent.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
AdverseEvent.actualityrequiredPattern: actual
AdverseEvent.categoryextensibleAdverseEventCategory
AdverseEvent.eventpreferredAdverseEventTermVS
AdverseEvent.seriousnessexampleAdverseEventSeriousness
AdverseEvent.severityrequiredAdverseEventSeverity
AdverseEvent.outcomerequiredAdverseEventOutcome
AdverseEvent.suspectEntity.causality.assessmentexampleAdverseEventCausalityAssessment
AdverseEvent.suspectEntity.causality.methodexampleAdverseEventCausalityMethod

Differential View

This structure is derived from AdverseEvent

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..*AdverseEventMedical care, research study or other healthcare event causing physical injury
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... severity-or-grade S0..1CodeableConceptRadiotherapy Adverse Event Grade
URL: http://hl7.org/fhir/us/codex-radiation-therapy/StructureDefinition/codexrt-radiotheraphy-adverse-event-severity-or-grade
Binding: Adverse Event Severity or Grade Value Set (required)
... actuality S1..1codeactual | potential
Required Pattern: actual
.... coding 1..*CodingCode defined by a terminology system
.... text S0..1stringVerbatim Text
... subject S1..1Reference(US Core Patient Profile)Subject impacted by event
... encounter S0..1Reference(Encounter)Encounter created as part of
... date S0..1dateTimeWhen the event occurred
... outcome S0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
... recorder S0..1Reference(Patient | Practitioner | PractitionerRole | RelatedPerson)Who recorded the adverse event
... suspectEntity S0..*BackboneElementThe suspected agent causing the adverse event
.... instance 1..1Reference(Radiotherapy Treated Phase | Radiotherapy Course Summary | Radiotherapy Treated Plan)Refers to the specific entity that caused the adverse event

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSet
AdverseEvent.eventpreferredAdverseEventTermVS

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
... Slices for extension 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... severity-or-grade S0..1CodeableConceptRadiotherapy Adverse Event Grade
URL: http://hl7.org/fhir/us/codex-radiation-therapy/StructureDefinition/codexrt-radiotheraphy-adverse-event-severity-or-grade
Binding: Adverse Event Severity or Grade Value Set (required)
... actuality ?!SΣ1..1codeactual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.


Required Pattern: actual
... event SΣ1..1CodeableConceptAdverse Event Term
Binding: Adverse Event Terms Value Set (preferred)
.... coding Σ1..*CodingCode defined by a terminology system
.... text SΣ0..1stringVerbatim Text
... subject SΣ1..1Reference(US Core Patient Profile)Subject impacted by event
... encounter SΣ0..1Reference(Encounter)Encounter created as part of
... date SΣ0..1dateTimeWhen the event occurred
... outcome SΣ0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).

... recorder SΣ0..1Reference(Patient | Practitioner | PractitionerRole | RelatedPerson)Who recorded the adverse event
... suspectEntity SΣ0..*BackboneElementThe suspected agent causing the adverse event
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... instance Σ1..1Reference(Radiotherapy Treated Phase | Radiotherapy Course Summary | Radiotherapy Treated Plan)Refers to the specific entity that caused the adverse event

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
AdverseEvent.actualityrequiredPattern: actual
AdverseEvent.eventpreferredAdverseEventTermVS
AdverseEvent.outcomerequiredAdverseEventOutcome

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 0..*ExtensionExtension
Slice: Unordered, Open by value:url
... severity-or-grade S0..1CodeableConceptRadiotherapy Adverse Event Grade
URL: http://hl7.org/fhir/us/codex-radiation-therapy/StructureDefinition/codexrt-radiotheraphy-adverse-event-severity-or-grade
Binding: Adverse Event Severity or Grade Value Set (required)
... modifierExtension ?!0..*ExtensionExtensions that cannot be ignored
... identifier Σ0..1IdentifierBusiness identifier for the event
... actuality ?!SΣ1..1codeactual | potential
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.


Required Pattern: actual
... 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 SΣ1..1CodeableConceptAdverse Event Term
Binding: Adverse Event Terms Value Set (preferred)
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
Slice: Unordered, Open by value:url
.... coding Σ1..*CodingCode defined by a terminology system
.... text SΣ0..1stringVerbatim Text
... subject SΣ1..1Reference(US Core Patient Profile)Subject impacted by event
... encounter SΣ0..1Reference(Encounter)Encounter created as part of
... date SΣ0..1dateTimeWhen the event occurred
... detected Σ0..1dateTimeWhen the event was detected
... recordedDate Σ0..1dateTimeWhen the event was recorded
... resultingCondition Σ0..*Reference(Condition)Effect on the subject due to this event
... location Σ0..1Reference(Location)Location where adverse event occurred
... seriousness Σ0..1CodeableConceptSeriousness of the event
Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.

... severity Σ0..1CodeableConceptmild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.

... outcome SΣ0..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).

... recorder SΣ0..1Reference(Patient | Practitioner | PractitionerRole | RelatedPerson)Who recorded the adverse event
... contributor Σ0..*Reference(Practitioner | PractitionerRole | Device)Who was involved in the adverse event or the potential adverse event
... suspectEntity SΣ0..*BackboneElementThe suspected agent causing the adverse event
.... id 0..1stringUnique id for inter-element referencing
.... extension 0..*ExtensionAdditional content defined by implementations
.... modifierExtension ?!Σ0..*ExtensionExtensions that cannot be ignored even if unrecognized
.... instance Σ1..1Reference(Radiotherapy Treated Phase | Radiotherapy Course Summary | Radiotherapy Treated Plan)Refers to the specific entity that caused the adverse event
.... causality Σ0..*BackboneElementInformation on the possible cause of the event
..... id 0..1stringUnique id for inter-element referencing
..... extension 0..*ExtensionAdditional content defined by implementations
..... 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 Σ0..1Reference(Practitioner | PractitionerRole)AdverseEvent.suspectEntity.causalityAuthor
..... method Σ0..1CodeableConceptProbabilityScale | Bayesian | Checklist
Binding: AdverseEventCausalityMethod (example): TODO.

... subjectMedicalHistory Σ0..*Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference)AdverseEvent.subjectMedicalHistory
... referenceDocument Σ0..*Reference(DocumentReference)AdverseEvent.referenceDocument
... study Σ0..*Reference(ResearchStudy)AdverseEvent.study

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / Code
AdverseEvent.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
AdverseEvent.actualityrequiredPattern: actual
AdverseEvent.categoryextensibleAdverseEventCategory
AdverseEvent.eventpreferredAdverseEventTermVS
AdverseEvent.seriousnessexampleAdverseEventSeriousness
AdverseEvent.severityrequiredAdverseEventSeverity
AdverseEvent.outcomerequiredAdverseEventOutcome
AdverseEvent.suspectEntity.causality.assessmentexampleAdverseEventCausalityAssessment
AdverseEvent.suspectEntity.causality.methodexampleAdverseEventCausalityMethod

 

Other representations of profile: CSV, Excel, Schematron