Example CRVS Implementation Guide - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

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Resource Profile: CRVS Event Profile (AE Based)

Event definition to capture CRVS events based on Adverse Event resource

Usage:

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

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	An event that may be related to unintended effects on a patient or research participant
outcome		0..*	CodeableConcept	Type of outcome from the adverse event Binding: CRVS Event Categories Value Set (required)
suspectEntity		0..0
contributingFactor		0..0
preventiveAction		0..0
mitigatingAction		0..0
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
AdverseEvent.outcome	required	CRVSEventCategoriesVS (a valid code from CRVS Event Category CodeSystem) http://example.org/ValueSet/crvs-event-categories-vs from this IG

Name	Flags	Card.	Type	Description & Constraints
AdverseEvent		0..*	AdverseEvent	An event that may be related to unintended effects on a patient or research participant
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
status	?!Σ	1..1	code	in-progress | completed | entered-in-error | unknown Binding: AdverseEventStatus (required): Codes identifying the lifecycle stage of an event.
actuality	?!Σ	1..1	code	actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
subject	Σ	1..1	Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject)	Subject impacted by event
outcome	Σ	0..*	CodeableConcept	Type of outcome from the adverse event Binding: CRVS Event Categories Value Set (required)
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
AdverseEvent.status	required	AdverseEventStatus http://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0 from the FHIR Standard
AdverseEvent.actuality	required	AdverseEventActuality http://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0 from the FHIR Standard
AdverseEvent.outcome	required	CRVSEventCategoriesVS (a valid code from CRVS Event Category CodeSystem) http://example.org/ValueSet/crvs-event-categories-vs from this IG
AdverseEvent.contributingFactor.item[x]	example	AdverseEventContributingFactor http://hl7.org/fhir/ValueSet/adverse-event-contributing-factor from the FHIR Standard
AdverseEvent.preventiveAction.item[x]	example	AdverseEventPreventiveAction http://hl7.org/fhir/ValueSet/adverse-event-preventive-action from the FHIR Standard
AdverseEvent.mitigatingAction.item[x]	example	AdverseEventMitigatingAction http://hl7.org/fhir/ValueSet/adverse-event-mitigating-action from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Name	Flags	Card.	Type	Description & Constraints
AdverseEvent		0..*	AdverseEvent	An event that may be related to unintended effects on a patient or research participant
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: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Business identifier for the event
status	?!Σ	1..1	code	in-progress | completed | entered-in-error | unknown Binding: AdverseEventStatus (required): Codes identifying the lifecycle stage of an event.
actuality	?!Σ	1..1	code	actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
category	Σ	0..*	CodeableConcept	wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site Binding: AdverseEventCategory (example): Overall categorization of the event, e.g. product-related or situational.
code	Σ	0..1	CodeableConcept	Event or incident that occurred or was averted Binding: AdverseEventType (example): Detailed type of event.
subject	Σ	1..1	Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject)	Subject impacted by event
encounter	Σ	0..1	Reference(Encounter)	The Encounter associated with the start of the AdverseEvent
occurrence[x]	Σ	0..1		When the event occurred
occurrenceDateTime			dateTime
occurrencePeriod			Period
occurrenceTiming			Timing
detected	Σ	0..1	dateTime	When the event was detected
recordedDate	Σ	0..1	dateTime	When the event was recorded
resultingEffect	Σ	0..*	Reference(Condition | Observation)	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 or gravity of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.
outcome	Σ	0..*	CodeableConcept	Type of outcome from the adverse event Binding: CRVS Event Categories Value Set (required)
recorder	Σ	0..1	Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject)	Who recorded the adverse event
participant	Σ	0..*	BackboneElement	Who was involved in the adverse event or the potential adverse event and what they did
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
function	Σ	0..1	CodeableConcept	Type of involvement Binding: AdverseEventParticipantFunction (example): Codes describing the type of involvement of the actor in the adverse event.
actor	Σ	1..1	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | ResearchSubject)	Who was involved in the adverse event or the potential adverse event
study	Σ	0..*	Reference(ResearchStudy)	Research study that the subject is enrolled in
expectedInResearchStudy		0..1	boolean	Considered likely or probable or anticipated in the research study
supportingInfo	Σ	0..*	BackboneElement	Supporting information relevant to 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
item[x]	Σ	1..1		Subject medical history or document relevant to this adverse event Binding: AdverseEventSupportingInforation (example): Codes describing the supporting information relevant to the event.
itemReference			Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationStatement | QuestionnaireResponse)
itemCodeableConcept			CodeableConcept
note	Σ	0..*	Annotation	Comment on adverse event
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
AdverseEvent.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
AdverseEvent.status	required	AdverseEventStatus http://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0 from the FHIR Standard
AdverseEvent.actuality	required	AdverseEventActuality http://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0 from the FHIR Standard
AdverseEvent.category	example	AdverseEventCategory http://hl7.org/fhir/ValueSet/adverse-event-category from the FHIR Standard
AdverseEvent.code	example	AdverseEventType http://hl7.org/fhir/ValueSet/adverse-event-type from the FHIR Standard
AdverseEvent.seriousness	example	AdverseEventSeriousness http://hl7.org/fhir/ValueSet/adverse-event-seriousness from the FHIR Standard
AdverseEvent.outcome	required	CRVSEventCategoriesVS (a valid code from CRVS Event Category CodeSystem) http://example.org/ValueSet/crvs-event-categories-vs from this IG
AdverseEvent.participant.function	example	AdverseEventParticipantFunction http://hl7.org/fhir/ValueSet/adverse-event-participant-function from the FHIR Standard
AdverseEvent.suspectEntity.causality.assessmentMethod	example	AdverseEventCausalityMethod http://hl7.org/fhir/ValueSet/adverse-event-causality-method from the FHIR Standard
AdverseEvent.suspectEntity.causality.entityRelatedness	example	AdverseEventCausalityAssessment http://hl7.org/fhir/ValueSet/adverse-event-causality-assess from the FHIR Standard
AdverseEvent.contributingFactor.item[x]	example	AdverseEventContributingFactor http://hl7.org/fhir/ValueSet/adverse-event-contributing-factor from the FHIR Standard
AdverseEvent.preventiveAction.item[x]	example	AdverseEventPreventiveAction http://hl7.org/fhir/ValueSet/adverse-event-preventive-action from the FHIR Standard
AdverseEvent.mitigatingAction.item[x]	example	AdverseEventMitigatingAction http://hl7.org/fhir/ValueSet/adverse-event-mitigating-action from the FHIR Standard
AdverseEvent.supportingInfo.item[x]	example	AdverseEventSupportingInforation http://hl7.org/fhir/ValueSet/adverse-event-supporting-info from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from AdverseEvent

Summary

Prohibited: 4 elements

Differential View

This structure is derived from AdverseEvent

Name	Flags	Card.	Type	Description & Constraints
AdverseEvent		0..*	AdverseEvent	An event that may be related to unintended effects on a patient or research participant
outcome		0..*	CodeableConcept	Type of outcome from the adverse event Binding: CRVS Event Categories Value Set (required)
suspectEntity		0..0
contributingFactor		0..0
preventiveAction		0..0
mitigatingAction		0..0
Documentation for this format

Terminology Bindings (Differential)

Path	Conformance	ValueSet	URI
AdverseEvent.outcome	required	CRVSEventCategoriesVS (a valid code from CRVS Event Category CodeSystem) http://example.org/ValueSet/crvs-event-categories-vs from this IG

Key Elements View

Name	Flags	Card.	Type	Description & Constraints
AdverseEvent		0..*	AdverseEvent	An event that may be related to unintended effects on a patient or research participant
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created
contained		0..*	Resource	Contained, inline Resources
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
status	?!Σ	1..1	code	in-progress | completed | entered-in-error | unknown Binding: AdverseEventStatus (required): Codes identifying the lifecycle stage of an event.
actuality	?!Σ	1..1	code	actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
subject	Σ	1..1	Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject)	Subject impacted by event
outcome	Σ	0..*	CodeableConcept	Type of outcome from the adverse event Binding: CRVS Event Categories Value Set (required)
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
AdverseEvent.status	required	AdverseEventStatus http://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0 from the FHIR Standard
AdverseEvent.actuality	required	AdverseEventActuality http://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0 from the FHIR Standard
AdverseEvent.outcome	required	CRVSEventCategoriesVS (a valid code from CRVS Event Category CodeSystem) http://example.org/ValueSet/crvs-event-categories-vs from this IG
AdverseEvent.contributingFactor.item[x]	example	AdverseEventContributingFactor http://hl7.org/fhir/ValueSet/adverse-event-contributing-factor from the FHIR Standard
AdverseEvent.preventiveAction.item[x]	example	AdverseEventPreventiveAction http://hl7.org/fhir/ValueSet/adverse-event-preventive-action from the FHIR Standard
AdverseEvent.mitigatingAction.item[x]	example	AdverseEventMitigatingAction http://hl7.org/fhir/ValueSet/adverse-event-mitigating-action from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

Snapshot View

Name	Flags	Card.	Type	Description & Constraints
AdverseEvent		0..*	AdverseEvent	An event that may be related to unintended effects on a patient or research participant
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: AllLanguages (required): IETF language tag for a human language Additional Bindings Purpose CommonLanguages Starter Set
text		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored
identifier	Σ	0..*	Identifier	Business identifier for the event
status	?!Σ	1..1	code	in-progress | completed | entered-in-error | unknown Binding: AdverseEventStatus (required): Codes identifying the lifecycle stage of an event.
actuality	?!Σ	1..1	code	actual | potential Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.
category	Σ	0..*	CodeableConcept	wrong-patient | procedure-mishap | medication-mishap | device | unsafe-physical-environment | hospital-aquired-infection | wrong-body-site Binding: AdverseEventCategory (example): Overall categorization of the event, e.g. product-related or situational.
code	Σ	0..1	CodeableConcept	Event or incident that occurred or was averted Binding: AdverseEventType (example): Detailed type of event.
subject	Σ	1..1	Reference(Patient | Group | Practitioner | RelatedPerson | ResearchSubject)	Subject impacted by event
encounter	Σ	0..1	Reference(Encounter)	The Encounter associated with the start of the AdverseEvent
occurrence[x]	Σ	0..1		When the event occurred
occurrenceDateTime			dateTime
occurrencePeriod			Period
occurrenceTiming			Timing
detected	Σ	0..1	dateTime	When the event was detected
recordedDate	Σ	0..1	dateTime	When the event was recorded
resultingEffect	Σ	0..*	Reference(Condition | Observation)	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 or gravity of the event Binding: AdverseEventSeriousness (example): Overall seriousness of this event for the patient.
outcome	Σ	0..*	CodeableConcept	Type of outcome from the adverse event Binding: CRVS Event Categories Value Set (required)
recorder	Σ	0..1	Reference(Patient | Practitioner | PractitionerRole | RelatedPerson | ResearchSubject)	Who recorded the adverse event
participant	Σ	0..*	BackboneElement	Who was involved in the adverse event or the potential adverse event and what they did
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
function	Σ	0..1	CodeableConcept	Type of involvement Binding: AdverseEventParticipantFunction (example): Codes describing the type of involvement of the actor in the adverse event.
actor	Σ	1..1	Reference(Practitioner | PractitionerRole | Organization | CareTeam | Patient | Device | RelatedPerson | ResearchSubject)	Who was involved in the adverse event or the potential adverse event
study	Σ	0..*	Reference(ResearchStudy)	Research study that the subject is enrolled in
expectedInResearchStudy		0..1	boolean	Considered likely or probable or anticipated in the research study
supportingInfo	Σ	0..*	BackboneElement	Supporting information relevant to 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
item[x]	Σ	1..1		Subject medical history or document relevant to this adverse event Binding: AdverseEventSupportingInforation (example): Codes describing the supporting information relevant to the event.
itemReference			Reference(Condition | Observation | AllergyIntolerance | FamilyMemberHistory | Immunization | Procedure | DocumentReference | MedicationAdministration | MedicationStatement | QuestionnaireResponse)
itemCodeableConcept			CodeableConcept
note	Σ	0..*	Annotation	Comment on adverse event
Documentation for this format

Terminology Bindings

Path	Conformance	ValueSet	URI
AdverseEvent.language	required	AllLanguages http://hl7.org/fhir/ValueSet/all-languages|5.0.0 from the FHIR Standard
AdverseEvent.status	required	AdverseEventStatus http://hl7.org/fhir/ValueSet/adverse-event-status|5.0.0 from the FHIR Standard
AdverseEvent.actuality	required	AdverseEventActuality http://hl7.org/fhir/ValueSet/adverse-event-actuality|5.0.0 from the FHIR Standard
AdverseEvent.category	example	AdverseEventCategory http://hl7.org/fhir/ValueSet/adverse-event-category from the FHIR Standard
AdverseEvent.code	example	AdverseEventType http://hl7.org/fhir/ValueSet/adverse-event-type from the FHIR Standard
AdverseEvent.seriousness	example	AdverseEventSeriousness http://hl7.org/fhir/ValueSet/adverse-event-seriousness from the FHIR Standard
AdverseEvent.outcome	required	CRVSEventCategoriesVS (a valid code from CRVS Event Category CodeSystem) http://example.org/ValueSet/crvs-event-categories-vs from this IG
AdverseEvent.participant.function	example	AdverseEventParticipantFunction http://hl7.org/fhir/ValueSet/adverse-event-participant-function from the FHIR Standard
AdverseEvent.suspectEntity.causality.assessmentMethod	example	AdverseEventCausalityMethod http://hl7.org/fhir/ValueSet/adverse-event-causality-method from the FHIR Standard
AdverseEvent.suspectEntity.causality.entityRelatedness	example	AdverseEventCausalityAssessment http://hl7.org/fhir/ValueSet/adverse-event-causality-assess from the FHIR Standard
AdverseEvent.contributingFactor.item[x]	example	AdverseEventContributingFactor http://hl7.org/fhir/ValueSet/adverse-event-contributing-factor from the FHIR Standard
AdverseEvent.preventiveAction.item[x]	example	AdverseEventPreventiveAction http://hl7.org/fhir/ValueSet/adverse-event-preventive-action from the FHIR Standard
AdverseEvent.mitigatingAction.item[x]	example	AdverseEventMitigatingAction http://hl7.org/fhir/ValueSet/adverse-event-mitigating-action from the FHIR Standard
AdverseEvent.supportingInfo.item[x]	example	AdverseEventSupportingInforation http://hl7.org/fhir/ValueSet/adverse-event-supporting-info from the FHIR Standard

Constraints

Id	Grade	Path(s)	Details	Requirements
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().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(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()
ele-1	error	**ALL** elements	All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count())
ext-1	error	**ALL** extensions	Must have either extensions or value[x], not both : extension.exists() != value.exists()

This structure is derived from AdverseEvent

Summary

Prohibited: 4 elements

Other representations of profile: CSV, Excel, Schematron