Kenya National Cancer Control Programme (NCCP) FHIR Implementation Guide
0.1.0 - ci-build Kenya flag

Kenya National Cancer Control Programme (NCCP) FHIR Implementation Guide, published by Digital Health Agency (DHA), Kenya. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/IntelliSOFT-Consulting/nccpFHIRIG/ and changes regularly. See the Directory of published versions

Resource Profile: NCCP Oncology Adverse Event

Official URL: https://nshr-uat.sha.go.ke/fhir/StructureDefinition/nccp-oncology-adverse-event Version: 0.1.0
Draft as of 2026-06-04 Computable Name: OncologyAdverseEvent

Captures an oncology adverse event including CTCAE grade, attribution and actions taken.

Usages:

You can also check for usages in the FHIR IG Statistics

Formal Views of Profile Content

Description Differentials, Snapshots, and other representations.

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... meta Σ 0..1 Meta Metadata about the resource
.... profile SΣ 1..* canonical(StructureDefinition) Profiles this resource claims to conform to
... 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
.... extension:ctcaeGrade S 1..1 integer CTCAE Grade Extension
URL: https://nshr-uat.sha.go.ke/fhir/StructureDefinition/nccp-ctcae-grade-extension
.... extension:ctcaeActionTaken S 0..* code CTCAE Action Taken Extension
URL: https://nshr-uat.sha.go.ke/fhir/StructureDefinition/nccp-ctcae-action-taken-extension
Binding: Kenya CTCAE Action Taken Value Set (required)
... identifier SΣ 0..1 Identifier Business identifier for the event
... actuality ?!SΣ 1..1 code actual | potential
Binding: AdverseEventActuality (required)
... category SΣ 1..* 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: Kenya Adverse Event Category Value Set (required)
... event SΣ 1..1 CodeableConcept Type of the event itself in relation to the subject
Binding: Kenya CTCAE Adverse Event Terms Value Set (required)
... subject SΣ 1..1 Reference(Patient) Subject impacted by event
... encounter SΣ 1..1 Reference(Encounter) Encounter created as part of
... date SΣ 1..1 dateTime When the event occurred
... detected SΣ 0..1 dateTime When the event was detected
... severity SΣ 1..1 CodeableConcept mild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.
... outcome SΣ 1..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).
... recorder SΣ 1..1 Reference(Practitioner) Who recorded the adverse event
... suspectEntity Σ 0..* BackboneElement The suspected agent causing the adverse event
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... instance SΣ 1..1 Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) Refers to the specific entity that caused the adverse event
.... causality Σ 0..* BackboneElement Information on the possible cause of the event
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... assessment SΣ 0..1 CodeableConcept Assessment of if the entity caused the event
Binding: Kenya CTCAE Attribution Value Set (required)
... referenceDocument SΣ 0..* Reference(DocumentReference) AdverseEvent.referenceDocument

doco 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 required Kenya Adverse Event Category Value Set 📦0.1.0 This IG
AdverseEvent.event Base required Kenya CTCAE Adverse Event Terms Value Set 📦0.1.0 This IG
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 required Kenya CTCAE Attribution Value Set 📦0.1.0 This IG

Constraints

Id Grade Path(s) Description Expression
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()
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()

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... meta
.... profile S 1..* canonical(StructureDefinition) Profiles this resource claims to conform to
... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:ctcaeGrade S 1..1 integer CTCAE Grade Extension
URL: https://nshr-uat.sha.go.ke/fhir/StructureDefinition/nccp-ctcae-grade-extension
.... extension:ctcaeActionTaken S 0..* code CTCAE Action Taken Extension
URL: https://nshr-uat.sha.go.ke/fhir/StructureDefinition/nccp-ctcae-action-taken-extension
Binding: Kenya CTCAE Action Taken Value Set (required)
... identifier S 0..1 Identifier Business identifier for the event
... category S 1..* 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: Kenya Adverse Event Category Value Set (required)
... event S 1..1 CodeableConcept Type of the event itself in relation to the subject
Binding: Kenya CTCAE Adverse Event Terms Value Set (required)
... subject S 1..1 Reference(Patient) Subject impacted by event
... encounter S 1..1 Reference(Encounter) Encounter created as part of
... date S 1..1 dateTime When the event occurred
... detected S 0..1 dateTime When the event was detected
... severity S 1..1 CodeableConcept mild | moderate | severe
... outcome S 1..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
... recorder S 1..1 Reference(Practitioner) Who recorded the adverse event
... suspectEntity
.... instance S 1..1 Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) Refers to the specific entity that caused the adverse event
.... causality
..... assessment S 0..1 CodeableConcept Assessment of if the entity caused the event
Binding: Kenya CTCAE Attribution Value Set (required)
... referenceDocument S 0..* Reference(DocumentReference) AdverseEvent.referenceDocument

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
AdverseEvent.actuality Base required AdverseEventActuality 📦4.0.1 FHIR Std.
AdverseEvent.category Base required Kenya Adverse Event Category Value Set 📦0.1.0 This IG
AdverseEvent.event Base required Kenya CTCAE Adverse Event Terms Value Set 📦0.1.0 This IG
AdverseEvent.suspectEntity.​causality.assessment Base required Kenya CTCAE Attribution Value Set 📦0.1.0 This IG
NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ 0..1 id Version specific identifier
.... lastUpdated Σ 0..1 instant When the resource version last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile SΣ 1..* canonical(StructureDefinition) Profiles this resource claims to conform to
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.
Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
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
.... extension:ctcaeGrade S 1..1 integer CTCAE Grade Extension
URL: https://nshr-uat.sha.go.ke/fhir/StructureDefinition/nccp-ctcae-grade-extension
.... extension:ctcaeActionTaken S 0..* code CTCAE Action Taken Extension
URL: https://nshr-uat.sha.go.ke/fhir/StructureDefinition/nccp-ctcae-action-taken-extension
Binding: Kenya CTCAE Action Taken Value Set (required)
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier SΣ 0..1 Identifier Business identifier for the event
... actuality ?!SΣ 1..1 code actual | potential
Binding: AdverseEventActuality (required)
... category SΣ 1..* 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: Kenya Adverse Event Category Value Set (required)
... event SΣ 1..1 CodeableConcept Type of the event itself in relation to the subject
Binding: Kenya CTCAE Adverse Event Terms Value Set (required)
... subject SΣ 1..1 Reference(Patient) Subject impacted by event
... encounter SΣ 1..1 Reference(Encounter) Encounter created as part of
... date SΣ 1..1 dateTime When the event occurred
... detected SΣ 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 SΣ 1..1 CodeableConcept mild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.
... outcome SΣ 1..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).
... recorder SΣ 1..1 Reference(Practitioner) 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 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
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... instance SΣ 1..1 Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | 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 SΣ 0..1 CodeableConcept Assessment of if the entity caused the event
Binding: Kenya CTCAE Attribution Value Set (required)
..... 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 SΣ 0..* Reference(DocumentReference) AdverseEvent.referenceDocument
... study Σ 0..* Reference(ResearchStudy) AdverseEvent.study

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
AdverseEvent.meta.security Base extensible SecurityLabels 📍4.0.1 FHIR Std.
AdverseEvent.meta.tag Base example Common Tags 📍4.0.1 FHIR Std.
AdverseEvent.language Base preferred Common Languages 📍4.0.1 FHIR Std.
AdverseEvent.actuality Base required AdverseEventActuality 📦4.0.1 FHIR Std.
AdverseEvent.category Base required Kenya Adverse Event Category Value Set 📦0.1.0 This IG
AdverseEvent.event Base required Kenya CTCAE Adverse Event Terms Value Set 📦0.1.0 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 required Kenya CTCAE Attribution Value Set 📦0.1.0 This IG
AdverseEvent.suspectEntity.​causality.method Base example AdverseEventCausalityMethod 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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()
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()

Summary

Mandatory: 9 elements(1 nested mandatory element)
Must-Support: 17 elements

Extensions

This structure refers to these extensions:

Key Elements View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... meta Σ 0..1 Meta Metadata about the resource
.... profile SΣ 1..* canonical(StructureDefinition) Profiles this resource claims to conform to
... 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
.... extension:ctcaeGrade S 1..1 integer CTCAE Grade Extension
URL: https://nshr-uat.sha.go.ke/fhir/StructureDefinition/nccp-ctcae-grade-extension
.... extension:ctcaeActionTaken S 0..* code CTCAE Action Taken Extension
URL: https://nshr-uat.sha.go.ke/fhir/StructureDefinition/nccp-ctcae-action-taken-extension
Binding: Kenya CTCAE Action Taken Value Set (required)
... identifier SΣ 0..1 Identifier Business identifier for the event
... actuality ?!SΣ 1..1 code actual | potential
Binding: AdverseEventActuality (required)
... category SΣ 1..* 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: Kenya Adverse Event Category Value Set (required)
... event SΣ 1..1 CodeableConcept Type of the event itself in relation to the subject
Binding: Kenya CTCAE Adverse Event Terms Value Set (required)
... subject SΣ 1..1 Reference(Patient) Subject impacted by event
... encounter SΣ 1..1 Reference(Encounter) Encounter created as part of
... date SΣ 1..1 dateTime When the event occurred
... detected SΣ 0..1 dateTime When the event was detected
... severity SΣ 1..1 CodeableConcept mild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.
... outcome SΣ 1..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).
... recorder SΣ 1..1 Reference(Practitioner) Who recorded the adverse event
... suspectEntity Σ 0..* BackboneElement The suspected agent causing the adverse event
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... instance SΣ 1..1 Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) Refers to the specific entity that caused the adverse event
.... causality Σ 0..* BackboneElement Information on the possible cause of the event
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... assessment SΣ 0..1 CodeableConcept Assessment of if the entity caused the event
Binding: Kenya CTCAE Attribution Value Set (required)
... referenceDocument SΣ 0..* Reference(DocumentReference) AdverseEvent.referenceDocument

doco 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 required Kenya Adverse Event Category Value Set 📦0.1.0 This IG
AdverseEvent.event Base required Kenya CTCAE Adverse Event Terms Value Set 📦0.1.0 This IG
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 required Kenya CTCAE Attribution Value Set 📦0.1.0 This IG

Constraints

Id Grade Path(s) Description Expression
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()
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()

Differential View

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. AdverseEvent 0..* AdverseEvent Medical care, research study or other healthcare event causing physical injury
... meta
.... profile S 1..* canonical(StructureDefinition) Profiles this resource claims to conform to
... Slices for extension 1..* Extension Extension
Slice: Unordered, Open by value:url
.... extension:ctcaeGrade S 1..1 integer CTCAE Grade Extension
URL: https://nshr-uat.sha.go.ke/fhir/StructureDefinition/nccp-ctcae-grade-extension
.... extension:ctcaeActionTaken S 0..* code CTCAE Action Taken Extension
URL: https://nshr-uat.sha.go.ke/fhir/StructureDefinition/nccp-ctcae-action-taken-extension
Binding: Kenya CTCAE Action Taken Value Set (required)
... identifier S 0..1 Identifier Business identifier for the event
... category S 1..* 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: Kenya Adverse Event Category Value Set (required)
... event S 1..1 CodeableConcept Type of the event itself in relation to the subject
Binding: Kenya CTCAE Adverse Event Terms Value Set (required)
... subject S 1..1 Reference(Patient) Subject impacted by event
... encounter S 1..1 Reference(Encounter) Encounter created as part of
... date S 1..1 dateTime When the event occurred
... detected S 0..1 dateTime When the event was detected
... severity S 1..1 CodeableConcept mild | moderate | severe
... outcome S 1..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
... recorder S 1..1 Reference(Practitioner) Who recorded the adverse event
... suspectEntity
.... instance S 1..1 Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | Device) Refers to the specific entity that caused the adverse event
.... causality
..... assessment S 0..1 CodeableConcept Assessment of if the entity caused the event
Binding: Kenya CTCAE Attribution Value Set (required)
... referenceDocument S 0..* Reference(DocumentReference) AdverseEvent.referenceDocument

doco Documentation for this format

Terminology Bindings (Differential)

Path Status Usage ValueSet Version Source
AdverseEvent.actuality Base required AdverseEventActuality 📦4.0.1 FHIR Std.
AdverseEvent.category Base required Kenya Adverse Event Category Value Set 📦0.1.0 This IG
AdverseEvent.event Base required Kenya CTCAE Adverse Event Terms Value Set 📦0.1.0 This IG
AdverseEvent.suspectEntity.​causality.assessment Base required Kenya CTCAE Attribution Value Set 📦0.1.0 This IG

Snapshot ViewView

NameFlagsCard.TypeDescription & Constraints    Filter: Filtersdoco
.. 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
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
.... versionId Σ 0..1 id Version specific identifier
.... lastUpdated Σ 0..1 instant When the resource version last changed
.... source Σ 0..1 uri Identifies where the resource comes from
.... profile SΣ 1..* canonical(StructureDefinition) Profiles this resource claims to conform to
.... security Σ 0..* Coding Security Labels applied to this resource
Binding: All Security Labels (extensible): Security Labels from the Healthcare Privacy and Security Classification System.
.... tag Σ 0..* Coding Tags applied to this resource
Binding: CommonTags (example): Codes that represent various types of tags, commonly workflow-related; e.g. "Needs review by Dr. Jones".
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: CommonLanguages (preferred): A human language.
Additional BindingsPurpose
AllLanguages Max Binding
... text 0..1 Narrative Text summary of the resource, for human interpretation
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
.... extension:ctcaeGrade S 1..1 integer CTCAE Grade Extension
URL: https://nshr-uat.sha.go.ke/fhir/StructureDefinition/nccp-ctcae-grade-extension
.... extension:ctcaeActionTaken S 0..* code CTCAE Action Taken Extension
URL: https://nshr-uat.sha.go.ke/fhir/StructureDefinition/nccp-ctcae-action-taken-extension
Binding: Kenya CTCAE Action Taken Value Set (required)
... modifierExtension ?! 0..* Extension Extensions that cannot be ignored
... identifier SΣ 0..1 Identifier Business identifier for the event
... actuality ?!SΣ 1..1 code actual | potential
Binding: AdverseEventActuality (required)
... category SΣ 1..* 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: Kenya Adverse Event Category Value Set (required)
... event SΣ 1..1 CodeableConcept Type of the event itself in relation to the subject
Binding: Kenya CTCAE Adverse Event Terms Value Set (required)
... subject SΣ 1..1 Reference(Patient) Subject impacted by event
... encounter SΣ 1..1 Reference(Encounter) Encounter created as part of
... date SΣ 1..1 dateTime When the event occurred
... detected SΣ 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 SΣ 1..1 CodeableConcept mild | moderate | severe
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.
... outcome SΣ 1..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown
Binding: AdverseEventOutcome (required): TODO (and should this be required?).
... recorder SΣ 1..1 Reference(Practitioner) 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 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
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... instance SΣ 1..1 Reference(Immunization | Procedure | Substance | Medication | MedicationAdministration | MedicationStatement | 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 SΣ 0..1 CodeableConcept Assessment of if the entity caused the event
Binding: Kenya CTCAE Attribution Value Set (required)
..... 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 SΣ 0..* Reference(DocumentReference) AdverseEvent.referenceDocument
... study Σ 0..* Reference(ResearchStudy) AdverseEvent.study

doco Documentation for this format

Terminology Bindings

Path Status Usage ValueSet Version Source
AdverseEvent.meta.security Base extensible SecurityLabels 📍4.0.1 FHIR Std.
AdverseEvent.meta.tag Base example Common Tags 📍4.0.1 FHIR Std.
AdverseEvent.language Base preferred Common Languages 📍4.0.1 FHIR Std.
AdverseEvent.actuality Base required AdverseEventActuality 📦4.0.1 FHIR Std.
AdverseEvent.category Base required Kenya Adverse Event Category Value Set 📦0.1.0 This IG
AdverseEvent.event Base required Kenya CTCAE Adverse Event Terms Value Set 📦0.1.0 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 required Kenya CTCAE Attribution Value Set 📦0.1.0 This IG
AdverseEvent.suspectEntity.​causality.method Base example AdverseEventCausalityMethod 📍4.0.1 FHIR Std.

Constraints

Id Grade Path(s) Description Expression
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()
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()

Summary

Mandatory: 9 elements(1 nested mandatory element)
Must-Support: 17 elements

Extensions

This structure refers to these extensions:

 

Other representations of profile: CSV, Excel, Schematron