CodeX Radiation Therapy
2.0.0 - STU2 United States of America flag

CodeX Radiation Therapy, published by HL7 International / Cross-Group Projects. This guide is not an authorized publication; it is the continuous build for version 2.0.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/codex-radiation-therapy/ and changes regularly. 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: 2.0.0
Draft as of 2024-11-20 Computable Name: RadiotherapyAdverseEvent
Other Identifiers: OID:2.16.840.1.113883.4.642.40.14.42.5

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..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... severity S 0..1 CodeableConcept Adverse Event Severity
URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-severity
Binding: AdverseEventSeverity (preferred)
.... grade 0..1 CodeableConcept Adverse Event Grade
URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-grade
Binding: Adverse Event Clinical Research Grades (preferred)
... actuality S 1..1 code actual | potential
Required Pattern: actual
... event S 1..1 CodeableConcept Adverse Event Term
Binding: Adverse Event Terms Value Set (preferred)
.... coding 1..* Coding Code defined by a terminology system
.... text S 0..1 string Verbatim Text
... encounter S 0..1 Reference(Encounter) Encounter created as part of
... date S 0..1 dateTime When the event occurred
... outcome S 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
... recorder S 0..1 Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) Who recorded the adverse event
... suspectEntity S 0..* BackboneElement The suspected agent causing the adverse event
.... instance 1..1 Reference(Radiotherapy Treated Phase | Radiotherapy Course Summary | Radiotherapy Treated Plan | Device) Refers to the specific entity that caused the adverse event

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
AdverseEvent.eventpreferredAdverseEventTermVS
http://hl7.org/fhir/us/codex-radiation-therapy/ValueSet/codexrt-radiotherapy-adverse-event-termVS
from this IG
NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... severity S 0..1 CodeableConcept Adverse Event Severity
URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-severity
Binding: AdverseEventSeverity (preferred)
.... grade 0..1 CodeableConcept Adverse Event Grade
URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-grade
Binding: Adverse Event Clinical Research Grades (preferred)
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... event SΣ 1..1 CodeableConcept Adverse Event Term
Binding: Adverse Event Terms Value Set (preferred)
.... coding Σ 1..* Coding Code defined by a terminology system
.... text SΣ 0..1 string Verbatim Text
... subject SΣ 1..1 Reference(US Core Patient Profile) Subject impacted by event
... encounter SΣ 0..1 Reference(Encounter) Encounter created as part of
... date SΣ 0..1 dateTime When the event occurred
... outcome SΣ 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).

... recorder SΣ 0..1 Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) Who recorded the adverse event
... suspectEntity SΣ 0..* BackboneElement The suspected agent causing the adverse event
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... instance Σ 1..1 Reference(Radiotherapy Treated Phase | Radiotherapy Course Summary | Radiotherapy Treated Plan | Device) Refers to the specific entity that caused the adverse event

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
AdverseEvent.actualityrequiredPattern: actual
http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
from the FHIR Standard
AdverseEvent.eventpreferredAdverseEventTermVS
http://hl7.org/fhir/us/codex-radiation-therapy/ValueSet/codexrt-radiotherapy-adverse-event-termVS
from this IG
AdverseEvent.outcomerequiredAdverseEventOutcome
http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1
from the FHIR Standard
NameFlagsCard.TypeDescription & Constraintsdoco
.. 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.

Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... severity S 0..1 CodeableConcept Adverse Event Severity
URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-severity
Binding: AdverseEventSeverity (preferred)
.... grade 0..1 CodeableConcept Adverse Event Grade
URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-grade
Binding: Adverse Event Clinical Research Grades (preferred)
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... 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.


Required Pattern: 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 Adverse Event Term
Binding: Adverse Event Terms Value Set (preferred)
.... 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 1..* Coding Code defined by a terminology system
.... text SΣ 0..1 string Verbatim Text
... subject SΣ 1..1 Reference(US Core Patient Profile) Subject impacted by event
... encounter SΣ 0..1 Reference(Encounter) Encounter created as part of
... date SΣ 0..1 dateTime When the event occurred
... detected Σ 0..1 dateTime When the event was detected
... recordedDate Σ 0..1 dateTime When the event was recorded
... resultingCondition Σ 0..* Reference(Condition) Effect on the subject due to this event
... location Σ 0..1 Reference(Location) Location where adverse event occurred
... seriousness Σ 0..1 CodeableConcept Seriousness of the event
Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.

... 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 SΣ 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).

... recorder SΣ 0..1 Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) Who recorded the adverse event
... contributor Σ 0..* Reference(Practitioner | PractitionerRole | Device) Who was involved in the adverse event or the potential adverse event
... suspectEntity SΣ 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 Σ 1..1 Reference(Radiotherapy Treated Phase | Radiotherapy Course Summary | Radiotherapy Treated Plan | Device) Refers to the specific entity that caused the adverse event
.... causality Σ 0..* BackboneElement Information on the possible cause of the event
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... assessment Σ 0..1 CodeableConcept Assessment of if the entity caused the event
Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.

..... productRelatedness Σ 0..1 string AdverseEvent.suspectEntity.causalityProductRelatedness
..... author Σ 0..1 Reference(Practitioner | PractitionerRole) AdverseEvent.suspectEntity.causalityAuthor
..... method Σ 0..1 CodeableConcept ProbabilityScale | Bayesian | Checklist
Binding: AdverseEventCausalityMethod (example): TODO.

... subjectMedicalHistory Σ 0..* Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) AdverseEvent.subjectMedicalHistory
... referenceDocument Σ 0..* Reference(DocumentReference) AdverseEvent.referenceDocument
... study Σ 0..* Reference(ResearchStudy) AdverseEvent.study

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
AdverseEvent.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
AdverseEvent.actualityrequiredPattern: actual
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.eventpreferredAdverseEventTermVS
http://hl7.org/fhir/us/codex-radiation-therapy/ValueSet/codexrt-radiotherapy-adverse-event-termVS
from this IG
AdverseEvent.seriousnessexampleAdverseEventSeriousness
http://hl7.org/fhir/ValueSet/adverse-event-seriousness
from the FHIR Standard
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..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... severity S 0..1 CodeableConcept Adverse Event Severity
URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-severity
Binding: AdverseEventSeverity (preferred)
.... grade 0..1 CodeableConcept Adverse Event Grade
URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-grade
Binding: Adverse Event Clinical Research Grades (preferred)
... actuality S 1..1 code actual | potential
Required Pattern: actual
... event S 1..1 CodeableConcept Adverse Event Term
Binding: Adverse Event Terms Value Set (preferred)
.... coding 1..* Coding Code defined by a terminology system
.... text S 0..1 string Verbatim Text
... encounter S 0..1 Reference(Encounter) Encounter created as part of
... date S 0..1 dateTime When the event occurred
... outcome S 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
... recorder S 0..1 Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) Who recorded the adverse event
... suspectEntity S 0..* BackboneElement The suspected agent causing the adverse event
.... instance 1..1 Reference(Radiotherapy Treated Phase | Radiotherapy Course Summary | Radiotherapy Treated Plan | Device) Refers to the specific entity that caused the adverse event

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
AdverseEvent.eventpreferredAdverseEventTermVS
http://hl7.org/fhir/us/codex-radiation-therapy/ValueSet/codexrt-radiotherapy-adverse-event-termVS
from this IG

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... severity S 0..1 CodeableConcept Adverse Event Severity
URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-severity
Binding: AdverseEventSeverity (preferred)
.... grade 0..1 CodeableConcept Adverse Event Grade
URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-grade
Binding: Adverse Event Clinical Research Grades (preferred)
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... event SΣ 1..1 CodeableConcept Adverse Event Term
Binding: Adverse Event Terms Value Set (preferred)
.... coding Σ 1..* Coding Code defined by a terminology system
.... text SΣ 0..1 string Verbatim Text
... subject SΣ 1..1 Reference(US Core Patient Profile) Subject impacted by event
... encounter SΣ 0..1 Reference(Encounter) Encounter created as part of
... date SΣ 0..1 dateTime When the event occurred
... outcome SΣ 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).

... recorder SΣ 0..1 Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) Who recorded the adverse event
... suspectEntity SΣ 0..* BackboneElement The suspected agent causing the adverse event
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... instance Σ 1..1 Reference(Radiotherapy Treated Phase | Radiotherapy Course Summary | Radiotherapy Treated Plan | Device) Refers to the specific entity that caused the adverse event

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
AdverseEvent.actualityrequiredPattern: actual
http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
from the FHIR Standard
AdverseEvent.eventpreferredAdverseEventTermVS
http://hl7.org/fhir/us/codex-radiation-therapy/ValueSet/codexrt-radiotherapy-adverse-event-termVS
from this IG
AdverseEvent.outcomerequiredAdverseEventOutcome
http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1
from the FHIR Standard

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. 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.

Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... Slices for extension 0..* Extension Extension
Slice: Unordered, Open by value:url
.... severity S 0..1 CodeableConcept Adverse Event Severity
URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-severity
Binding: AdverseEventSeverity (preferred)
.... grade 0..1 CodeableConcept Adverse Event Grade
URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-grade
Binding: Adverse Event Clinical Research Grades (preferred)
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... 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.


Required Pattern: 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 Adverse Event Term
Binding: Adverse Event Terms Value Set (preferred)
.... 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 1..* Coding Code defined by a terminology system
.... text SΣ 0..1 string Verbatim Text
... subject SΣ 1..1 Reference(US Core Patient Profile) Subject impacted by event
... encounter SΣ 0..1 Reference(Encounter) Encounter created as part of
... date SΣ 0..1 dateTime When the event occurred
... detected Σ 0..1 dateTime When the event was detected
... recordedDate Σ 0..1 dateTime When the event was recorded
... resultingCondition Σ 0..* Reference(Condition) Effect on the subject due to this event
... location Σ 0..1 Reference(Location) Location where adverse event occurred
... seriousness Σ 0..1 CodeableConcept Seriousness of the event
Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.

... 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 SΣ 0..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).

... recorder SΣ 0..1 Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) Who recorded the adverse event
... contributor Σ 0..* Reference(Practitioner | PractitionerRole | Device) Who was involved in the adverse event or the potential adverse event
... suspectEntity SΣ 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 Σ 1..1 Reference(Radiotherapy Treated Phase | Radiotherapy Course Summary | Radiotherapy Treated Plan | Device) Refers to the specific entity that caused the adverse event
.... causality Σ 0..* BackboneElement Information on the possible cause of the event
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... assessment Σ 0..1 CodeableConcept Assessment of if the entity caused the event
Binding: AdverseEventCausalityAssessment (example): Codes for the assessment of whether the entity caused the event.

..... productRelatedness Σ 0..1 string AdverseEvent.suspectEntity.causalityProductRelatedness
..... author Σ 0..1 Reference(Practitioner | PractitionerRole) AdverseEvent.suspectEntity.causalityAuthor
..... method Σ 0..1 CodeableConcept ProbabilityScale | Bayesian | Checklist
Binding: AdverseEventCausalityMethod (example): TODO.

... subjectMedicalHistory Σ 0..* Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | Media | DocumentReference) AdverseEvent.subjectMedicalHistory
... referenceDocument Σ 0..* Reference(DocumentReference) AdverseEvent.referenceDocument
... study Σ 0..* Reference(ResearchStudy) AdverseEvent.study

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
AdverseEvent.languagepreferredCommonLanguages
Additional Bindings Purpose
AllLanguages Max Binding
http://hl7.org/fhir/ValueSet/languages
from the FHIR Standard
AdverseEvent.actualityrequiredPattern: actual
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.eventpreferredAdverseEventTermVS
http://hl7.org/fhir/us/codex-radiation-therapy/ValueSet/codexrt-radiotherapy-adverse-event-termVS
from this IG
AdverseEvent.seriousnessexampleAdverseEventSeriousness
http://hl7.org/fhir/ValueSet/adverse-event-seriousness
from the FHIR Standard
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