Onconova Implementation Guide - Local Development build (v0.2.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

• Content
• Detailed Descriptions
• Mappings
• JSON

Resource Profile: Adverse Event Profile

A profile representing an adverse event experienced by a cancer patient as a result of an antineoplastic treatment, structured according to the Common Terminology Criteria for Adverse Events (CTCAE). This resource is used to capture and standardize the documentation of adverse events occurring during cancer care, including the type of event, its CTCAE grade, and any mitigation actions taken.

The profile constrains the base FHIR AdverseEvent resource to ensure consistent use of CTCAE codes and grades, and supports linkage to related treatments such as medications, radiotherapy, or surgical procedures documented in Onconova. The profile also provides extensions for recording mitigation strategies, supporting detailed tracking and management of adverse events in cancer patients.

Usages:

• This Profile is not used by any profiles in this Implementation Guide

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

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

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

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
AdverseEvent	C	0..*	AdverseEvent(4.0.1)	Medical care, research study or other healthcare event causing physical injury Constraints: ae-req-1, ae-req-2, ae-req-3, ae-req-4, ae-req-5, ae-req-6, ae-req-7
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:ctcGrade	C	1..1	integer	CTCAE Grade URL: http://onconova.github.io/fhir/StructureDefinition/onconova-ext-ctc-grade Constraints: ext-1, ctcae-grade
extension:adverseEventMitigation	C	0..*	(Complex)	Adverse Event Mitigation Action(s) URL: http://onconova.github.io/fhir/StructureDefinition/onconova-ext-adverse-event-mitigation Constraints: ext-1, drug-mitigation, adjustment-mitigation, procedural-mitigation
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored Constraints: ext-1
actuality	?!Σ	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	Not used in this profile Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational.
event	Σ	0..1	CodeableConcept	Type of the event itself in relation to the subject Binding: CTCAdverseEvents (0.2.0) (required)
subject	Σ	1..1	Reference(Cancer Patient Profile(0.2.0))	Subject impacted by event
encounter	Σ	0..1	Reference(Encounter)	Not used in this profile
detected	Σ	0..1	dateTime	Not used in this profile
recordedDate	Σ	0..1	dateTime	Not used in this profile
resultingCondition	Σ	0..*	Reference(Condition)	Not used in this profile
location	Σ	0..1	Reference(Location)	Not used in this profile
seriousness	Σ	0..1	CodeableConcept	Not used in this profile Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.
severity	Σ	0..1	CodeableConcept	Not used in this profile 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	Σ	0..1	Reference(Patient | Practitioner | PractitionerRole | RelatedPerson)	Not used in this profile
contributor	Σ	0..*	Reference(Practitioner | PractitionerRole | Device)	Not used in this profile
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
AdverseEvent.actuality	Base	required	AdverseEventActuality	📍4.0.1	FHIR Std.
AdverseEvent.category	Base	extensible	AdverseEventCategory	📍4.0.1	FHIR Std.
AdverseEvent.event	Base	required	CTC Adverse Events	📍0.2.0	This IG
AdverseEvent.seriousness	Base	example	AdverseEventSeriousness	📍4.0.1	FHIR Std.
AdverseEvent.severity	Base	required	AdverseEventSeverity	📍4.0.1	FHIR Std.
AdverseEvent.outcome	Base	required	AdverseEventOutcome	📍4.0.1	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
adjustment-mitigation	error	AdverseEvent.extension:adverseEventMitigation	If the mitigation category is 'Adjustment', then only mitigation adjustment must be specified.	extension('category').valueCodeableConcept.coding.code = 'C49157' implies (extension('adjustment').exists() and not extension('procedure').exists() and not extension('drug').exists())
ae-req-1	error	AdverseEvent	The subject element is required and must be provided.	subject.exists() and subject.resolve().is(Patient)
ae-req-2	error	AdverseEvent	The date element is required and must be provided.	date.exists() and date.hasValue()
ae-req-3	error	AdverseEvent	The event element is required and must be provided.	event.exists() and event.coding.exists()
ae-req-4	error	AdverseEvent	The CTC Grade extension is required and must be provided.	extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-ctc-grade').exists()
ae-req-5	error	AdverseEvent	The outcome is required and must be provided.	outcome.exists() and outcome.coding.exists()
ae-req-6	error	AdverseEvent	If suspectedEntity is provided, then at least one instance must exist.	suspectEntity.exists() implies (suspectEntity.count() > 0 and suspectEntity.instance.exists())
ae-req-7	error	AdverseEvent	If adverseEventMitigation extension is provided, then at least one instance must exist.	extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-adverse-event-mitigation').exists() implies extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-adverse-event-mitigation').count() > 0
ctcae-grade	error	AdverseEvent.extension:ctcGrade	The CTCAE grade must be between 1 and 5, inclusive.	valueInteger() >= 1 and valueInteger() <= 5
dom-2	error	AdverseEvent	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	AdverseEvent	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	contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	AdverseEvent	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated	contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	AdverseEvent	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	AdverseEvent	A resource should have narrative for robust management	text.`div`.exists()
drug-mitigation	error	AdverseEvent.extension:adverseEventMitigation	If the mitigation category is 'Drug', then only mitigation drug must be specified.	extension('category').valueCodeableConcept.coding.code = 'C49158' implies (extension('drug').exists() and not extension('procedure').exists() and not extension('adjustment').exists())
ele-1	error	AdverseEvent.implicitRules, AdverseEvent.extension, AdverseEvent.extension:ctcGrade, AdverseEvent.extension:adverseEventMitigation, AdverseEvent.modifierExtension, AdverseEvent.actuality, AdverseEvent.category, AdverseEvent.event, AdverseEvent.subject, AdverseEvent.encounter, AdverseEvent.detected, AdverseEvent.recordedDate, AdverseEvent.resultingCondition, AdverseEvent.location, AdverseEvent.seriousness, AdverseEvent.severity, AdverseEvent.outcome, AdverseEvent.recorder, AdverseEvent.contributor	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	AdverseEvent.extension, AdverseEvent.extension:ctcGrade, AdverseEvent.extension:adverseEventMitigation, AdverseEvent.modifierExtension	Must have either extensions or value[x], not both	extension.exists() != value.exists()
procedural-mitigation	error	AdverseEvent.extension:adverseEventMitigation	If the mitigation category is 'Procedure', then only mitigation procedure must be specified.	extension('category').valueCodeableConcept.coding.code = 'C49159' implies (extension('procedure').exists() and not extension('adjustment').exists() and not extension('drug').exists())

This structure is derived from AdverseEvent

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
AdverseEvent	C	0..*	AdverseEvent(4.0.1)	Medical care, research study or other healthcare event causing physical injury
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
extension:ctcGrade		1..1	integer	CTCAE Grade URL: http://onconova.github.io/fhir/StructureDefinition/onconova-ext-ctc-grade
extension:adverseEventMitigation		0..*	(Complex)	Adverse Event Mitigation Action(s) URL: http://onconova.github.io/fhir/StructureDefinition/onconova-ext-adverse-event-mitigation
actuality		1..1	code	actual | potential Required Pattern: actual
category		0..*	CodeableConcept	Not used in this profile
event		0..1	CodeableConcept	Type of the event itself in relation to the subject Binding: CTCAdverseEvents (0.2.0) (required)
subject		1..1	Reference(Cancer Patient Profile(0.2.0))	Subject impacted by event
encounter		0..1	Reference(Encounter)	Not used in this profile
detected		0..1	dateTime	Not used in this profile
recordedDate		0..1	dateTime	Not used in this profile
resultingCondition		0..*	Reference(Condition)	Not used in this profile
location		0..1	Reference(Location)	Not used in this profile
seriousness		0..1	CodeableConcept	Not used in this profile
severity		0..1	CodeableConcept	Not used in this profile
outcome	S	0..1	CodeableConcept	resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
recorder		0..1	Reference(Patient | Practitioner | PractitionerRole | RelatedPerson)	Not used in this profile
contributor		0..*	Reference(Practitioner | PractitionerRole | Device)	Not used in this profile
suspectEntity
instance		1..1	Reference(Medication Administration Profile(0.2.0) | Radiotherapy Summary Profile(0.2.0) | Surgical Procedure Profile(0.2.0))	Refers to the specific entity that caused the adverse event
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
AdverseEvent.event	Base	required	CTC Adverse Events	📍0.2.0	This IG

Constraints

Id	Grade	Path(s)	Description	Expression
ae-req-1	error	AdverseEvent	The subject element is required and must be provided.	subject.exists() and subject.resolve().is(Patient)
ae-req-2	error	AdverseEvent	The date element is required and must be provided.	date.exists() and date.hasValue()
ae-req-3	error	AdverseEvent	The event element is required and must be provided.	event.exists() and event.coding.exists()
ae-req-4	error	AdverseEvent	The CTC Grade extension is required and must be provided.	extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-ctc-grade').exists()
ae-req-5	error	AdverseEvent	The outcome is required and must be provided.	outcome.exists() and outcome.coding.exists()
ae-req-6	error	AdverseEvent	If suspectedEntity is provided, then at least one instance must exist.	suspectEntity.exists() implies (suspectEntity.count() > 0 and suspectEntity.instance.exists())
ae-req-7	error	AdverseEvent	If adverseEventMitigation extension is provided, then at least one instance must exist.	extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-adverse-event-mitigation').exists() implies extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-adverse-event-mitigation').count() > 0

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
AdverseEvent	C	0..*	AdverseEvent(4.0.1)	Medical care, research study or other healthcare event causing physical injury Constraints: ae-req-1, ae-req-2, ae-req-3, ae-req-4, ae-req-5, ae-req-6, ae-req-7
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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained		0..*	Resource	Contained, inline Resources
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:ctcGrade	C	1..1	integer	CTCAE Grade URL: http://onconova.github.io/fhir/StructureDefinition/onconova-ext-ctc-grade Constraints: ext-1, ctcae-grade
extension:adverseEventMitigation	C	0..*	(Complex)	Adverse Event Mitigation Action(s) URL: http://onconova.github.io/fhir/StructureDefinition/onconova-ext-adverse-event-mitigation Constraints: ext-1, drug-mitigation, adjustment-mitigation, procedural-mitigation
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored Constraints: ext-1
identifier	Σ	0..1	Identifier	Business identifier for the event
actuality	?!Σ	1..1	code	actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. Required Pattern: actual
category	Σ	0..*	CodeableConcept	Not used in this profile Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational.
event	Σ	0..1	CodeableConcept	Type of the event itself in relation to the subject Binding: CTCAdverseEvents (0.2.0) (required)
subject	Σ	1..1	Reference(Cancer Patient Profile(0.2.0))	Subject impacted by event
encounter	Σ	0..1	Reference(Encounter)	Not used in this profile
date	Σ	0..1	dateTime	When the event occurred
detected	Σ	0..1	dateTime	Not used in this profile
recordedDate	Σ	0..1	dateTime	Not used in this profile
resultingCondition	Σ	0..*	Reference(Condition)	Not used in this profile
location	Σ	0..1	Reference(Location)	Not used in this profile
seriousness	Σ	0..1	CodeableConcept	Not used in this profile Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.
severity	Σ	0..1	CodeableConcept	Not used in this profile 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	Σ	0..1	Reference(Patient | Practitioner | PractitionerRole | RelatedPerson)	Not used in this profile
contributor	Σ	0..*	Reference(Practitioner | PractitionerRole | Device)	Not used in this profile
suspectEntity	Σ	0..*	BackboneElement	The suspected agent causing the adverse event
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
instance	Σ	1..1	Reference(Medication Administration Profile(0.2.0) | Radiotherapy Summary Profile(0.2.0) | Surgical Procedure Profile(0.2.0))	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 Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
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	Status	Usage	ValueSet	Version	Source
AdverseEvent.language	Base	preferred	Common Languages	📍4.0.1	FHIR Std.
AdverseEvent.actuality	Base	required	AdverseEventActuality	📍4.0.1	FHIR Std.
AdverseEvent.category	Base	extensible	AdverseEventCategory	📍4.0.1	FHIR Std.
AdverseEvent.event	Base	required	CTC Adverse Events	📍0.2.0	This IG
AdverseEvent.seriousness	Base	example	AdverseEventSeriousness	📍4.0.1	FHIR Std.
AdverseEvent.severity	Base	required	AdverseEventSeverity	📍4.0.1	FHIR Std.
AdverseEvent.outcome	Base	required	AdverseEventOutcome	📍4.0.1	FHIR Std.
AdverseEvent.suspectEntity.​causality.assessment	Base	example	AdverseEventCausalityAssessment	📍4.0.1	FHIR Std.
AdverseEvent.suspectEntity.​causality.method	Base	example	AdverseEventCausalityMethod	📍4.0.1	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
adjustment-mitigation	error	AdverseEvent.extension:adverseEventMitigation	If the mitigation category is 'Adjustment', then only mitigation adjustment must be specified.	extension('category').valueCodeableConcept.coding.code = 'C49157' implies (extension('adjustment').exists() and not extension('procedure').exists() and not extension('drug').exists())
ae-req-1	error	AdverseEvent	The subject element is required and must be provided.	subject.exists() and subject.resolve().is(Patient)
ae-req-2	error	AdverseEvent	The date element is required and must be provided.	date.exists() and date.hasValue()
ae-req-3	error	AdverseEvent	The event element is required and must be provided.	event.exists() and event.coding.exists()
ae-req-4	error	AdverseEvent	The CTC Grade extension is required and must be provided.	extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-ctc-grade').exists()
ae-req-5	error	AdverseEvent	The outcome is required and must be provided.	outcome.exists() and outcome.coding.exists()
ae-req-6	error	AdverseEvent	If suspectedEntity is provided, then at least one instance must exist.	suspectEntity.exists() implies (suspectEntity.count() > 0 and suspectEntity.instance.exists())
ae-req-7	error	AdverseEvent	If adverseEventMitigation extension is provided, then at least one instance must exist.	extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-adverse-event-mitigation').exists() implies extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-adverse-event-mitigation').count() > 0
ctcae-grade	error	AdverseEvent.extension:ctcGrade	The CTCAE grade must be between 1 and 5, inclusive.	valueInteger() >= 1 and valueInteger() <= 5
dom-2	error	AdverseEvent	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	AdverseEvent	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	contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	AdverseEvent	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated	contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	AdverseEvent	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	AdverseEvent	A resource should have narrative for robust management	text.`div`.exists()
drug-mitigation	error	AdverseEvent.extension:adverseEventMitigation	If the mitigation category is 'Drug', then only mitigation drug must be specified.	extension('category').valueCodeableConcept.coding.code = 'C49158' implies (extension('drug').exists() and not extension('procedure').exists() and not extension('adjustment').exists())
ele-1	error	AdverseEvent.meta, AdverseEvent.implicitRules, AdverseEvent.language, AdverseEvent.text, AdverseEvent.extension, AdverseEvent.extension:ctcGrade, AdverseEvent.extension:adverseEventMitigation, AdverseEvent.modifierExtension, AdverseEvent.identifier, AdverseEvent.actuality, AdverseEvent.category, AdverseEvent.event, AdverseEvent.subject, AdverseEvent.encounter, AdverseEvent.date, AdverseEvent.detected, AdverseEvent.recordedDate, AdverseEvent.resultingCondition, AdverseEvent.location, AdverseEvent.seriousness, AdverseEvent.severity, AdverseEvent.outcome, AdverseEvent.recorder, AdverseEvent.contributor, AdverseEvent.suspectEntity, AdverseEvent.suspectEntity.extension, AdverseEvent.suspectEntity.modifierExtension, AdverseEvent.suspectEntity.instance, AdverseEvent.suspectEntity.causality, AdverseEvent.suspectEntity.causality.extension, AdverseEvent.suspectEntity.causality.modifierExtension, AdverseEvent.suspectEntity.causality.assessment, AdverseEvent.suspectEntity.causality.productRelatedness, AdverseEvent.suspectEntity.causality.author, AdverseEvent.suspectEntity.causality.method, AdverseEvent.subjectMedicalHistory, AdverseEvent.referenceDocument, AdverseEvent.study	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	AdverseEvent.extension, AdverseEvent.extension:ctcGrade, AdverseEvent.extension:adverseEventMitigation, AdverseEvent.modifierExtension, AdverseEvent.suspectEntity.extension, AdverseEvent.suspectEntity.modifierExtension, AdverseEvent.suspectEntity.causality.extension, AdverseEvent.suspectEntity.causality.modifierExtension	Must have either extensions or value[x], not both	extension.exists() != value.exists()
procedural-mitigation	error	AdverseEvent.extension:adverseEventMitigation	If the mitigation category is 'Procedure', then only mitigation procedure must be specified.	extension('category').valueCodeableConcept.coding.code = 'C49159' implies (extension('procedure').exists() and not extension('adjustment').exists() and not extension('drug').exists())

This structure is derived from AdverseEvent

Summary

Mandatory: 2 elements
Must-Support: 1 element

Structures

This structure refers to these other structures:

• Cancer Patient Profile (http://onconova.github.io/fhir/StructureDefinition/onconova-cancer-patient|0.2.0)
• Medication Administration Profile (http://onconova.github.io/fhir/StructureDefinition/onconova-medication-administration|0.2.0)
• Radiotherapy Summary Profile (http://onconova.github.io/fhir/StructureDefinition/onconova-radiotherapy-summary|0.2.0)
• Surgical Procedure Profile (http://onconova.github.io/fhir/StructureDefinition/onconova-surgical-procedure|0.2.0)

Extensions

This structure refers to these extensions:

• http://onconova.github.io/fhir/StructureDefinition/onconova-ext-ctc-grade|0.2.0
• http://onconova.github.io/fhir/StructureDefinition/onconova-ext-adverse-event-mitigation|0.2.0

Key Elements View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
AdverseEvent	C	0..*	AdverseEvent(4.0.1)	Medical care, research study or other healthcare event causing physical injury Constraints: ae-req-1, ae-req-2, ae-req-3, ae-req-4, ae-req-5, ae-req-6, ae-req-7
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:ctcGrade	C	1..1	integer	CTCAE Grade URL: http://onconova.github.io/fhir/StructureDefinition/onconova-ext-ctc-grade Constraints: ext-1, ctcae-grade
extension:adverseEventMitigation	C	0..*	(Complex)	Adverse Event Mitigation Action(s) URL: http://onconova.github.io/fhir/StructureDefinition/onconova-ext-adverse-event-mitigation Constraints: ext-1, drug-mitigation, adjustment-mitigation, procedural-mitigation
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored Constraints: ext-1
actuality	?!Σ	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	Not used in this profile Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational.
event	Σ	0..1	CodeableConcept	Type of the event itself in relation to the subject Binding: CTCAdverseEvents (0.2.0) (required)
subject	Σ	1..1	Reference(Cancer Patient Profile(0.2.0))	Subject impacted by event
encounter	Σ	0..1	Reference(Encounter)	Not used in this profile
detected	Σ	0..1	dateTime	Not used in this profile
recordedDate	Σ	0..1	dateTime	Not used in this profile
resultingCondition	Σ	0..*	Reference(Condition)	Not used in this profile
location	Σ	0..1	Reference(Location)	Not used in this profile
seriousness	Σ	0..1	CodeableConcept	Not used in this profile Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.
severity	Σ	0..1	CodeableConcept	Not used in this profile 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	Σ	0..1	Reference(Patient | Practitioner | PractitionerRole | RelatedPerson)	Not used in this profile
contributor	Σ	0..*	Reference(Practitioner | PractitionerRole | Device)	Not used in this profile
Documentation for this format

Terminology Bindings

Path	Status	Usage	ValueSet	Version	Source
AdverseEvent.actuality	Base	required	AdverseEventActuality	📍4.0.1	FHIR Std.
AdverseEvent.category	Base	extensible	AdverseEventCategory	📍4.0.1	FHIR Std.
AdverseEvent.event	Base	required	CTC Adverse Events	📍0.2.0	This IG
AdverseEvent.seriousness	Base	example	AdverseEventSeriousness	📍4.0.1	FHIR Std.
AdverseEvent.severity	Base	required	AdverseEventSeverity	📍4.0.1	FHIR Std.
AdverseEvent.outcome	Base	required	AdverseEventOutcome	📍4.0.1	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
adjustment-mitigation	error	AdverseEvent.extension:adverseEventMitigation	If the mitigation category is 'Adjustment', then only mitigation adjustment must be specified.	extension('category').valueCodeableConcept.coding.code = 'C49157' implies (extension('adjustment').exists() and not extension('procedure').exists() and not extension('drug').exists())
ae-req-1	error	AdverseEvent	The subject element is required and must be provided.	subject.exists() and subject.resolve().is(Patient)
ae-req-2	error	AdverseEvent	The date element is required and must be provided.	date.exists() and date.hasValue()
ae-req-3	error	AdverseEvent	The event element is required and must be provided.	event.exists() and event.coding.exists()
ae-req-4	error	AdverseEvent	The CTC Grade extension is required and must be provided.	extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-ctc-grade').exists()
ae-req-5	error	AdverseEvent	The outcome is required and must be provided.	outcome.exists() and outcome.coding.exists()
ae-req-6	error	AdverseEvent	If suspectedEntity is provided, then at least one instance must exist.	suspectEntity.exists() implies (suspectEntity.count() > 0 and suspectEntity.instance.exists())
ae-req-7	error	AdverseEvent	If adverseEventMitigation extension is provided, then at least one instance must exist.	extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-adverse-event-mitigation').exists() implies extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-adverse-event-mitigation').count() > 0
ctcae-grade	error	AdverseEvent.extension:ctcGrade	The CTCAE grade must be between 1 and 5, inclusive.	valueInteger() >= 1 and valueInteger() <= 5
dom-2	error	AdverseEvent	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	AdverseEvent	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	contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	AdverseEvent	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated	contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	AdverseEvent	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	AdverseEvent	A resource should have narrative for robust management	text.`div`.exists()
drug-mitigation	error	AdverseEvent.extension:adverseEventMitigation	If the mitigation category is 'Drug', then only mitigation drug must be specified.	extension('category').valueCodeableConcept.coding.code = 'C49158' implies (extension('drug').exists() and not extension('procedure').exists() and not extension('adjustment').exists())
ele-1	error	AdverseEvent.implicitRules, AdverseEvent.extension, AdverseEvent.extension:ctcGrade, AdverseEvent.extension:adverseEventMitigation, AdverseEvent.modifierExtension, AdverseEvent.actuality, AdverseEvent.category, AdverseEvent.event, AdverseEvent.subject, AdverseEvent.encounter, AdverseEvent.detected, AdverseEvent.recordedDate, AdverseEvent.resultingCondition, AdverseEvent.location, AdverseEvent.seriousness, AdverseEvent.severity, AdverseEvent.outcome, AdverseEvent.recorder, AdverseEvent.contributor	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	AdverseEvent.extension, AdverseEvent.extension:ctcGrade, AdverseEvent.extension:adverseEventMitigation, AdverseEvent.modifierExtension	Must have either extensions or value[x], not both	extension.exists() != value.exists()
procedural-mitigation	error	AdverseEvent.extension:adverseEventMitigation	If the mitigation category is 'Procedure', then only mitigation procedure must be specified.	extension('category').valueCodeableConcept.coding.code = 'C49159' implies (extension('procedure').exists() and not extension('adjustment').exists() and not extension('drug').exists())

Differential View

This structure is derived from AdverseEvent

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
AdverseEvent	C	0..*	AdverseEvent(4.0.1)	Medical care, research study or other healthcare event causing physical injury
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url
extension:ctcGrade		1..1	integer	CTCAE Grade URL: http://onconova.github.io/fhir/StructureDefinition/onconova-ext-ctc-grade
extension:adverseEventMitigation		0..*	(Complex)	Adverse Event Mitigation Action(s) URL: http://onconova.github.io/fhir/StructureDefinition/onconova-ext-adverse-event-mitigation
actuality		1..1	code	actual | potential Required Pattern: actual
category		0..*	CodeableConcept	Not used in this profile
event		0..1	CodeableConcept	Type of the event itself in relation to the subject Binding: CTCAdverseEvents (0.2.0) (required)
subject		1..1	Reference(Cancer Patient Profile(0.2.0))	Subject impacted by event
encounter		0..1	Reference(Encounter)	Not used in this profile
detected		0..1	dateTime	Not used in this profile
recordedDate		0..1	dateTime	Not used in this profile
resultingCondition		0..*	Reference(Condition)	Not used in this profile
location		0..1	Reference(Location)	Not used in this profile
seriousness		0..1	CodeableConcept	Not used in this profile
severity		0..1	CodeableConcept	Not used in this profile
outcome	S	0..1	CodeableConcept	resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
recorder		0..1	Reference(Patient | Practitioner | PractitionerRole | RelatedPerson)	Not used in this profile
contributor		0..*	Reference(Practitioner | PractitionerRole | Device)	Not used in this profile
suspectEntity
instance		1..1	Reference(Medication Administration Profile(0.2.0) | Radiotherapy Summary Profile(0.2.0) | Surgical Procedure Profile(0.2.0))	Refers to the specific entity that caused the adverse event
Documentation for this format

Terminology Bindings (Differential)

Path	Status	Usage	ValueSet	Version	Source
AdverseEvent.event	Base	required	CTC Adverse Events	📍0.2.0	This IG

Constraints

Id	Grade	Path(s)	Description	Expression
ae-req-1	error	AdverseEvent	The subject element is required and must be provided.	subject.exists() and subject.resolve().is(Patient)
ae-req-2	error	AdverseEvent	The date element is required and must be provided.	date.exists() and date.hasValue()
ae-req-3	error	AdverseEvent	The event element is required and must be provided.	event.exists() and event.coding.exists()
ae-req-4	error	AdverseEvent	The CTC Grade extension is required and must be provided.	extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-ctc-grade').exists()
ae-req-5	error	AdverseEvent	The outcome is required and must be provided.	outcome.exists() and outcome.coding.exists()
ae-req-6	error	AdverseEvent	If suspectedEntity is provided, then at least one instance must exist.	suspectEntity.exists() implies (suspectEntity.count() > 0 and suspectEntity.instance.exists())
ae-req-7	error	AdverseEvent	If adverseEventMitigation extension is provided, then at least one instance must exist.	extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-adverse-event-mitigation').exists() implies extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-adverse-event-mitigation').count() > 0

Snapshot View

Name	Flags	Card.	Type	Description & Constraints    Filter: Bindings Constraints Obligations
AdverseEvent	C	0..*	AdverseEvent(4.0.1)	Medical care, research study or other healthcare event causing physical injury Constraints: ae-req-1, ae-req-2, ae-req-3, ae-req-4, ae-req-5, ae-req-6, ae-req-7
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 This profile does not constrain the narrative in regard to content, language, or traceability to data elements
contained		0..*	Resource	Contained, inline Resources
Slices for extension		1..*	Extension	Extension Slice: Unordered, Open by value:url Constraints: ext-1
extension:ctcGrade	C	1..1	integer	CTCAE Grade URL: http://onconova.github.io/fhir/StructureDefinition/onconova-ext-ctc-grade Constraints: ext-1, ctcae-grade
extension:adverseEventMitigation	C	0..*	(Complex)	Adverse Event Mitigation Action(s) URL: http://onconova.github.io/fhir/StructureDefinition/onconova-ext-adverse-event-mitigation Constraints: ext-1, drug-mitigation, adjustment-mitigation, procedural-mitigation
modifierExtension	?!	0..*	Extension	Extensions that cannot be ignored Constraints: ext-1
identifier	Σ	0..1	Identifier	Business identifier for the event
actuality	?!Σ	1..1	code	actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential. Required Pattern: actual
category	Σ	0..*	CodeableConcept	Not used in this profile Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational.
event	Σ	0..1	CodeableConcept	Type of the event itself in relation to the subject Binding: CTCAdverseEvents (0.2.0) (required)
subject	Σ	1..1	Reference(Cancer Patient Profile(0.2.0))	Subject impacted by event
encounter	Σ	0..1	Reference(Encounter)	Not used in this profile
date	Σ	0..1	dateTime	When the event occurred
detected	Σ	0..1	dateTime	Not used in this profile
recordedDate	Σ	0..1	dateTime	Not used in this profile
resultingCondition	Σ	0..*	Reference(Condition)	Not used in this profile
location	Σ	0..1	Reference(Location)	Not used in this profile
seriousness	Σ	0..1	CodeableConcept	Not used in this profile Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.
severity	Σ	0..1	CodeableConcept	Not used in this profile 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	Σ	0..1	Reference(Patient | Practitioner | PractitionerRole | RelatedPerson)	Not used in this profile
contributor	Σ	0..*	Reference(Practitioner | PractitionerRole | Device)	Not used in this profile
suspectEntity	Σ	0..*	BackboneElement	The suspected agent causing the adverse event
id		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
instance	Σ	1..1	Reference(Medication Administration Profile(0.2.0) | Radiotherapy Summary Profile(0.2.0) | Surgical Procedure Profile(0.2.0))	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 Constraints: ext-1
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized Constraints: ext-1
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	Status	Usage	ValueSet	Version	Source
AdverseEvent.language	Base	preferred	Common Languages	📍4.0.1	FHIR Std.
AdverseEvent.actuality	Base	required	AdverseEventActuality	📍4.0.1	FHIR Std.
AdverseEvent.category	Base	extensible	AdverseEventCategory	📍4.0.1	FHIR Std.
AdverseEvent.event	Base	required	CTC Adverse Events	📍0.2.0	This IG
AdverseEvent.seriousness	Base	example	AdverseEventSeriousness	📍4.0.1	FHIR Std.
AdverseEvent.severity	Base	required	AdverseEventSeverity	📍4.0.1	FHIR Std.
AdverseEvent.outcome	Base	required	AdverseEventOutcome	📍4.0.1	FHIR Std.
AdverseEvent.suspectEntity.​causality.assessment	Base	example	AdverseEventCausalityAssessment	📍4.0.1	FHIR Std.
AdverseEvent.suspectEntity.​causality.method	Base	example	AdverseEventCausalityMethod	📍4.0.1	FHIR Std.

Constraints

Id	Grade	Path(s)	Description	Expression
adjustment-mitigation	error	AdverseEvent.extension:adverseEventMitigation	If the mitigation category is 'Adjustment', then only mitigation adjustment must be specified.	extension('category').valueCodeableConcept.coding.code = 'C49157' implies (extension('adjustment').exists() and not extension('procedure').exists() and not extension('drug').exists())
ae-req-1	error	AdverseEvent	The subject element is required and must be provided.	subject.exists() and subject.resolve().is(Patient)
ae-req-2	error	AdverseEvent	The date element is required and must be provided.	date.exists() and date.hasValue()
ae-req-3	error	AdverseEvent	The event element is required and must be provided.	event.exists() and event.coding.exists()
ae-req-4	error	AdverseEvent	The CTC Grade extension is required and must be provided.	extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-ctc-grade').exists()
ae-req-5	error	AdverseEvent	The outcome is required and must be provided.	outcome.exists() and outcome.coding.exists()
ae-req-6	error	AdverseEvent	If suspectedEntity is provided, then at least one instance must exist.	suspectEntity.exists() implies (suspectEntity.count() > 0 and suspectEntity.instance.exists())
ae-req-7	error	AdverseEvent	If adverseEventMitigation extension is provided, then at least one instance must exist.	extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-adverse-event-mitigation').exists() implies extension('http://onconova.github.io/fhir/StructureDefinition/onconova-ext-adverse-event-mitigation').count() > 0
ctcae-grade	error	AdverseEvent.extension:ctcGrade	The CTCAE grade must be between 1 and 5, inclusive.	valueInteger() >= 1 and valueInteger() <= 5
dom-2	error	AdverseEvent	If the resource is contained in another resource, it SHALL NOT contain nested Resources	contained.contained.empty()
dom-3	error	AdverseEvent	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	contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().as(canonical) | %resource.descendants().as(uri) | %resource.descendants().as(url))) or descendants().where(reference = '#').exists() or descendants().where(as(canonical) = '#').exists() or descendants().where(as(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
dom-4	error	AdverseEvent	If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated	contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
dom-5	error	AdverseEvent	If a resource is contained in another resource, it SHALL NOT have a security label	contained.meta.security.empty()
dom-6	best practice	AdverseEvent	A resource should have narrative for robust management	text.`div`.exists()
drug-mitigation	error	AdverseEvent.extension:adverseEventMitigation	If the mitigation category is 'Drug', then only mitigation drug must be specified.	extension('category').valueCodeableConcept.coding.code = 'C49158' implies (extension('drug').exists() and not extension('procedure').exists() and not extension('adjustment').exists())
ele-1	error	AdverseEvent.meta, AdverseEvent.implicitRules, AdverseEvent.language, AdverseEvent.text, AdverseEvent.extension, AdverseEvent.extension:ctcGrade, AdverseEvent.extension:adverseEventMitigation, AdverseEvent.modifierExtension, AdverseEvent.identifier, AdverseEvent.actuality, AdverseEvent.category, AdverseEvent.event, AdverseEvent.subject, AdverseEvent.encounter, AdverseEvent.date, AdverseEvent.detected, AdverseEvent.recordedDate, AdverseEvent.resultingCondition, AdverseEvent.location, AdverseEvent.seriousness, AdverseEvent.severity, AdverseEvent.outcome, AdverseEvent.recorder, AdverseEvent.contributor, AdverseEvent.suspectEntity, AdverseEvent.suspectEntity.extension, AdverseEvent.suspectEntity.modifierExtension, AdverseEvent.suspectEntity.instance, AdverseEvent.suspectEntity.causality, AdverseEvent.suspectEntity.causality.extension, AdverseEvent.suspectEntity.causality.modifierExtension, AdverseEvent.suspectEntity.causality.assessment, AdverseEvent.suspectEntity.causality.productRelatedness, AdverseEvent.suspectEntity.causality.author, AdverseEvent.suspectEntity.causality.method, AdverseEvent.subjectMedicalHistory, AdverseEvent.referenceDocument, AdverseEvent.study	All FHIR elements must have a @value or children	hasValue() or (children().count() > id.count())
ext-1	error	AdverseEvent.extension, AdverseEvent.extension:ctcGrade, AdverseEvent.extension:adverseEventMitigation, AdverseEvent.modifierExtension, AdverseEvent.suspectEntity.extension, AdverseEvent.suspectEntity.modifierExtension, AdverseEvent.suspectEntity.causality.extension, AdverseEvent.suspectEntity.causality.modifierExtension	Must have either extensions or value[x], not both	extension.exists() != value.exists()
procedural-mitigation	error	AdverseEvent.extension:adverseEventMitigation	If the mitigation category is 'Procedure', then only mitigation procedure must be specified.	extension('category').valueCodeableConcept.coding.code = 'C49159' implies (extension('procedure').exists() and not extension('adjustment').exists() and not extension('drug').exists())

This structure is derived from AdverseEvent

Summary

Mandatory: 2 elements
Must-Support: 1 element

Structures

This structure refers to these other structures:

• Cancer Patient Profile (http://onconova.github.io/fhir/StructureDefinition/onconova-cancer-patient|0.2.0)
• Medication Administration Profile (http://onconova.github.io/fhir/StructureDefinition/onconova-medication-administration|0.2.0)
• Radiotherapy Summary Profile (http://onconova.github.io/fhir/StructureDefinition/onconova-radiotherapy-summary|0.2.0)
• Surgical Procedure Profile (http://onconova.github.io/fhir/StructureDefinition/onconova-surgical-procedure|0.2.0)

Extensions

This structure refers to these extensions:

• http://onconova.github.io/fhir/StructureDefinition/onconova-ext-ctc-grade|0.2.0
• http://onconova.github.io/fhir/StructureDefinition/onconova-ext-adverse-event-mitigation|0.2.0

Other representations of profile: CSV, Excel, Schematron