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

• Content
• Detailed Descriptions
• Mappings
• Examples
• XML
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Resource Profile: Radiotherapy Adverse Event ( Experimental )

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:

• Examples for this Resource Profile: AdverseEvent/RadiotherapyAdverseEvent-XRTS-07-22B

Formal Views of Profile Content

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

• Differential Table
• Key Elements Table
• Snapshot Table
• Statistics/References
• All

This structure is derived from AdverseEvent

Name	Flags	Card.	Type	Description & Constraints
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
subject	S	1..1	Reference(US Core Patient Profile)	Subject impacted by event
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
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
AdverseEvent.event	preferred	AdverseEventTermVS http://hl7.org/fhir/us/codex-radiation-therapy/ValueSet/codexrt-radiotherapy-adverse-event-termVS from this IG

Name	Flags	Card.	Type	Description & Constraints
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 for 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
severity	S	0..1	CodeableConcept	Adverse Event Severity URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-severity Binding: AdverseEventSeverity (preferred) ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
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) 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
actuality	?!SΣ	1..1	code	actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. ele-1: All FHIR elements must have a @value or children Required Pattern: actual
event	SΣ	1..1	CodeableConcept	Adverse Event Term Binding: Adverse Event Terms Value Set (preferred) ele-1: All FHIR elements must have a @value or children
coding	Σ	1..*	Coding	Code defined by a terminology system ele-1: All FHIR elements must have a @value or children
text	SΣ	0..1	string	Verbatim Text ele-1: All FHIR elements must have a @value or children
subject	SΣ	1..1	Reference(US Core Patient Profile)	Subject impacted by event ele-1: All FHIR elements must have a @value or children
encounter	SΣ	0..1	Reference(Encounter)	Encounter created as part of ele-1: All FHIR elements must have a @value or children
date	SΣ	0..1	dateTime	When the event occurred ele-1: All FHIR elements must have a @value or children
outcome	SΣ	0..1	CodeableConcept	resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?). ele-1: All FHIR elements must have a @value or children
recorder	SΣ	0..1	Reference(Patient | Practitioner | PractitionerRole | RelatedPerson)	Who recorded the adverse event ele-1: All FHIR elements must have a @value or children
suspectEntity	SΣ	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	Σ	1..1	Reference(Radiotherapy Treated Phase | Radiotherapy Course Summary | Radiotherapy Treated Plan | Device)	Refers to the specific entity that caused the adverse event ele-1: All FHIR elements must have a @value or children
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
AdverseEvent.actuality	required	Pattern: actual http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1 from the FHIR Standard
AdverseEvent.event	preferred	AdverseEventTermVS http://hl7.org/fhir/us/codex-radiation-therapy/ValueSet/codexrt-radiotherapy-adverse-event-termVS from this IG
AdverseEvent.outcome	required	AdverseEventOutcome http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1 from the FHIR Standard

Name	Flags	Card.	Type	Description & Constraints
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 Bindings Purpose 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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
AdverseEvent.language	preferred	CommonLanguages http://hl7.org/fhir/ValueSet/languages from the FHIR Standard Additional Bindings Purpose AllLanguages Max Binding
AdverseEvent.actuality	required	Pattern: actual http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1 from the FHIR Standard
AdverseEvent.category	extensible	AdverseEventCategory http://hl7.org/fhir/ValueSet/adverse-event-category from the FHIR Standard
AdverseEvent.event	preferred	AdverseEventTermVS http://hl7.org/fhir/us/codex-radiation-therapy/ValueSet/codexrt-radiotherapy-adverse-event-termVS from this IG
AdverseEvent.seriousness	example	AdverseEventSeriousness http://hl7.org/fhir/ValueSet/adverse-event-seriousness from the FHIR Standard
AdverseEvent.severity	required	AdverseEventSeverity http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1 from the FHIR Standard
AdverseEvent.outcome	required	AdverseEventOutcome http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1 from the FHIR Standard
AdverseEvent.suspectEntity.causality.assessment	example	AdverseEventCausalityAssessment http://hl7.org/fhir/ValueSet/adverse-event-causality-assess from the FHIR Standard
AdverseEvent.suspectEntity.causality.method	example	AdverseEventCausalityMethod http://hl7.org/fhir/ValueSet/adverse-event-causality-method from the FHIR Standard

This structure is derived from AdverseEvent

Summary

Mandatory: 2 elements
Must-Support: 10 elements

Structures

This structure refers to these other structures:

• US Core Patient Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-patient)
• Radiotherapy Treated Phase (http://hl7.org/fhir/us/codex-radiation-therapy/StructureDefinition/codexrt-radiotherapy-treated-phase)
• Radiotherapy Course Summary (http://hl7.org/fhir/us/codex-radiation-therapy/StructureDefinition/codexrt-radiotherapy-course-summary)
• Radiotherapy Treated Plan (http://hl7.org/fhir/us/codex-radiation-therapy/StructureDefinition/codexrt-radiotherapy-treated-plan)

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-severity
• http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-grade

Differential View

This structure is derived from AdverseEvent

Name	Flags	Card.	Type	Description & Constraints
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
subject	S	1..1	Reference(US Core Patient Profile)	Subject impacted by event
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
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
AdverseEvent.event	preferred	AdverseEventTermVS http://hl7.org/fhir/us/codex-radiation-therapy/ValueSet/codexrt-radiotherapy-adverse-event-termVS from this IG

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
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 for 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
severity	S	0..1	CodeableConcept	Adverse Event Severity URL: http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-severity Binding: AdverseEventSeverity (preferred) ele-1: All FHIR elements must have a @value or children ext-1: Must have either extensions or value[x], not both
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) 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
actuality	?!SΣ	1..1	code	actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. ele-1: All FHIR elements must have a @value or children Required Pattern: actual
event	SΣ	1..1	CodeableConcept	Adverse Event Term Binding: Adverse Event Terms Value Set (preferred) ele-1: All FHIR elements must have a @value or children
coding	Σ	1..*	Coding	Code defined by a terminology system ele-1: All FHIR elements must have a @value or children
text	SΣ	0..1	string	Verbatim Text ele-1: All FHIR elements must have a @value or children
subject	SΣ	1..1	Reference(US Core Patient Profile)	Subject impacted by event ele-1: All FHIR elements must have a @value or children
encounter	SΣ	0..1	Reference(Encounter)	Encounter created as part of ele-1: All FHIR elements must have a @value or children
date	SΣ	0..1	dateTime	When the event occurred ele-1: All FHIR elements must have a @value or children
outcome	SΣ	0..1	CodeableConcept	resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown Binding: AdverseEventOutcome (required): TODO (and should this be required?). ele-1: All FHIR elements must have a @value or children
recorder	SΣ	0..1	Reference(Patient | Practitioner | PractitionerRole | RelatedPerson)	Who recorded the adverse event ele-1: All FHIR elements must have a @value or children
suspectEntity	SΣ	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	Σ	1..1	Reference(Radiotherapy Treated Phase | Radiotherapy Course Summary | Radiotherapy Treated Plan | Device)	Refers to the specific entity that caused the adverse event ele-1: All FHIR elements must have a @value or children
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
AdverseEvent.actuality	required	Pattern: actual http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1 from the FHIR Standard
AdverseEvent.event	preferred	AdverseEventTermVS http://hl7.org/fhir/us/codex-radiation-therapy/ValueSet/codexrt-radiotherapy-adverse-event-termVS from this IG
AdverseEvent.outcome	required	AdverseEventOutcome http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1 from the FHIR Standard

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
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 Bindings Purpose 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
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet / Code	URI
AdverseEvent.language	preferred	CommonLanguages http://hl7.org/fhir/ValueSet/languages from the FHIR Standard Additional Bindings Purpose AllLanguages Max Binding
AdverseEvent.actuality	required	Pattern: actual http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1 from the FHIR Standard
AdverseEvent.category	extensible	AdverseEventCategory http://hl7.org/fhir/ValueSet/adverse-event-category from the FHIR Standard
AdverseEvent.event	preferred	AdverseEventTermVS http://hl7.org/fhir/us/codex-radiation-therapy/ValueSet/codexrt-radiotherapy-adverse-event-termVS from this IG
AdverseEvent.seriousness	example	AdverseEventSeriousness http://hl7.org/fhir/ValueSet/adverse-event-seriousness from the FHIR Standard
AdverseEvent.severity	required	AdverseEventSeverity http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1 from the FHIR Standard
AdverseEvent.outcome	required	AdverseEventOutcome http://hl7.org/fhir/ValueSet/adverse-event-outcome|4.0.1 from the FHIR Standard
AdverseEvent.suspectEntity.causality.assessment	example	AdverseEventCausalityAssessment http://hl7.org/fhir/ValueSet/adverse-event-causality-assess from the FHIR Standard
AdverseEvent.suspectEntity.causality.method	example	AdverseEventCausalityMethod http://hl7.org/fhir/ValueSet/adverse-event-causality-method from the FHIR Standard

This structure is derived from AdverseEvent

Summary

Mandatory: 2 elements
Must-Support: 10 elements

Structures

This structure refers to these other structures:

• US Core Patient Profile (http://hl7.org/fhir/us/core/StructureDefinition/us-core-patient)
• Radiotherapy Treated Phase (http://hl7.org/fhir/us/codex-radiation-therapy/StructureDefinition/codexrt-radiotherapy-treated-phase)
• Radiotherapy Course Summary (http://hl7.org/fhir/us/codex-radiation-therapy/StructureDefinition/codexrt-radiotherapy-course-summary)
• Radiotherapy Treated Plan (http://hl7.org/fhir/us/codex-radiation-therapy/StructureDefinition/codexrt-radiotherapy-treated-plan)

Extensions

This structure refers to these extensions:

• http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-severity
• http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-grade

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