Fujitsu Healthy Living Implementation Guide
1.1.28 - release

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Resource Profile: Fujitsu Adverse Event Clinical Research

Official URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-adverseEvent-clinical-research Version: 1.1.28
Active as of 2025-07-09 Computable Name: FujitsuAdverseEventClinicalResearch

Copyright/Legal: Copyright 2022 FUJITSU LIMITED

This profile defines the patient’s adverse event clinical research.
このプロファイルは、患者の臨床研究の有害事象を定義します。

Usage:

Formal Views of Profile Content

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

This structure is derived from AdverseEvent

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..* AdverseEvent Fujitsu Adverse Event Clinical Research (臨床研究有害事象プロファイル)
... id 0..1 id Logical id of this artifact (自動採番される論理ID)
... meta 0..1 Meta Metadata about the resource (リソースのメタデータ)
... implicitRules 0..0
... language 0..0
... text 0..1 Narrative Text summary of the resource, for human interpretation (リソースの概要)
... contained 0..* Resource Contained, inline Resources (リソース内リソース)
... Slices for extension 0..* Extension Additional content defined by implementations (要素の拡張)
Slice: Unordered, Open by value:url
... research-subject-ref 0..1 Reference(ResearchSubject) Research Subject record of subject (被験者の研究対象記録)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-research-subject-ref
... caused-subject-to-discontinue-study 0..1 boolean Adverse event caused subject to discontinue the study (有害事象による被験者の試験中止)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-caused-subject-to-discontinue-study
... seriousness-criteria 0..* (Complex) Criteria reviewed in determining serious adverse event (重篤な有害事象を判断する際に検討される基準)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-seriousness-criteria
... ae-grade 0..1 CodeableConcept The degree of something undesirable, used in oncology trial (グレード)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-ae-grade
Binding: Adverse Event Clinical Research Grades (preferred)
... expected-in-research-study 0..1 boolean Considered likely or probable or anticipated in the research study (予想された結果かどうか)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-expected-in-research-study
... note 0..* Annotation Comment on adverse event (有害事象のコメント)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-note
... resolve-date 0..1 dateTime Adverse Event resolution date (解決日)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-resolve-date
... suspect-entity Σ 0..* (Complex) A suspected agent causing the adverse event (原因と疑われる薬剤)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-suspect-entity
... contributing-factor Σ 0..* (Complex) Contributing factors suspected to have increased the probability or severity of the adverse event (寄与要因)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-contributing-factor
... mitigating-action Σ 0..* (Complex) Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm (改善措置)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-mitigating-action
... supporting-info Σ 0..* (Complex) Subject medical history or document relevant to this adverse event (被験者の病歴またはこの有害事象に関連する文書)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-supporting-info
... participant 0..* (Complex) Who was involved in the adverse event or the potential adverse event and what they did (関係者)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-participant
... resultingEffect 0..* Reference(Fujitsu Condition Profile | Fujitsu Observation Common Profile | Fujitsu Observation LabResult Profile | Fujitsu Observation Vital Signs Profile | Fujitsu Observation BloodPressure Profile | Fujitsu Observation BMI Profile | Fujitsu Observation BodyHeight Profile | Fujitsu Observation BodyTemperature Profile | Fujitsu Observation BodyWeight Profile | Fujitsu Observation HeadCircum Profile | Fujitsu Observation HeartRate Profile | Fujitsu Observation OxygenSaturation Profile | Fujitsu Observation RespiratoryRate Profile) Effect on the subject due to this event (被験者への影響)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-resulting-effect
... Slices for modifierExtension 1..* Extension Extensions that cannot be ignored (無視できない拡張)
Slice: Unordered, Open by value:url
... modifierExtension:status Σ 1..1 FujitsuStatus in-progress | completed | entered-in-error | unknown (ワークフローの状態)
... identifier 0..1 Identifier Business Identifier for observation (識別子)
... actuality 1..1 code actual (有害事象の全体的な性質)
Required Pattern: actual
... category 0..* CodeableConcept product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment (有害事象のカテゴリ)
... event 1..1 CodeableConcept Event or incident that occurred or was averted (イベント)
Binding: AdverseEvent Type (example)
.... id 0..0
.... extension 0..0
.... Slices for coding 0..* Coding Code defined by a terminology system (イベントのコード)
Slice: Unordered, Open by value:system
..... coding:snomed 0..1 Coding Code defined by a terminology system (イベントを表すコード)
Binding: AdverseEvent Type (required)
...... id 0..0
...... extension 0..0
...... system 1..1 uri Identity of the terminology system (イベントを定義するコード体系)
Fixed Value: http://snomed.info/sct
...... version 0..0
...... code 1..1 code Symbol in syntax defined by the system (イベントを表すコード値)
...... display 1..1 string Representation defined by the system (イベントの表示名)
...... userSelected 0..0
.... text 0..1 string Plain text representation of the concept (イベント)
... subject 1..1 Reference(Fujitsu Patient Profile | Group | Fujitsu Practitioner Profile | RelatedPerson) Subject impacted by event (患者)
... encounter 0..1 Reference(Fujitsu Encounter Profile) Encounter created as part of (関連する外来または入院)
... date 0..1 dateTime When the event occurred (発生日)
... detected 0..1 dateTime When the event was detected (検出日)
... recordedDate 0..1 dateTime When the event was recorded (記録日)
... resultingCondition 0..0
... location 0..1 Reference(Location) Location where adverse event occurred (発生場所)
... seriousness 1..1 CodeableConcept Investigator defined severity of the adverse event, in relation to the subject not the resulting condition (重篤度)
Binding: AdverseEventSeriousness (required)
... severity 0..1 CodeableConcept mild | moderate | severe (深刻度)
... outcome 1..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown (アウトカム)
Binding: Adverse Event Clinical Research Outcomes (required)
... recorder 0..1 Reference(Fujitsu Patient Profile | Fujitsu Practitioner Profile | Fujitsu PractitionerRole Profile | RelatedPerson) Who recorded the adverse event (記録者)
... contributor 0..* Reference(Practitioner | PractitionerRole | Device) Who was involved in the adverse event or the potential adverse event (関与した人)
... suspectEntity 0..0
... subjectMedicalHistory 0..0
... referenceDocument 0..0
... study 1..1 Reference(ResearchStudy) AdverseEvent.study (臨床研究の参照)

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
AdverseEvent.eventexampleAdverseEventType
http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-type-vs
AdverseEvent.event.coding:snomedrequiredAdverseEventType
http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-type-vs
AdverseEvent.seriousnessrequiredAdverseEventSeriousness
http://terminology.hl7.org/ValueSet/adverse-event-seriousness
AdverseEvent.outcomerequiredAdverseEventClinicalResearchOutcomes
http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes
NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..* AdverseEvent Fujitsu Adverse Event Clinical Research (臨床研究有害事象プロファイル)
... id Σ 0..1 id Logical id of this artifact (自動採番される論理ID)
... meta Σ 0..1 Meta Metadata about the resource (リソースのメタデータ)
... text 0..1 Narrative Text summary of the resource, for human interpretation (リソースの概要)
... contained 0..* Resource Contained, inline Resources (リソース内リソース)
... Slices for extension 0..* Extension Additional content defined by implementations (要素の拡張)
Slice: Unordered, Open by value:url
... research-subject-ref 0..1 Reference(ResearchSubject) Research Subject record of subject (被験者の研究対象記録)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-research-subject-ref
... caused-subject-to-discontinue-study 0..1 boolean Adverse event caused subject to discontinue the study (有害事象による被験者の試験中止)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-caused-subject-to-discontinue-study
... seriousness-criteria 0..* (Complex) Criteria reviewed in determining serious adverse event (重篤な有害事象を判断する際に検討される基準)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-seriousness-criteria
... ae-grade 0..1 CodeableConcept The degree of something undesirable, used in oncology trial (グレード)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-ae-grade
Binding: Adverse Event Clinical Research Grades (preferred)
... expected-in-research-study 0..1 boolean Considered likely or probable or anticipated in the research study (予想された結果かどうか)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-expected-in-research-study
... note 0..* Annotation Comment on adverse event (有害事象のコメント)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-note
... resolve-date 0..1 dateTime Adverse Event resolution date (解決日)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-resolve-date
... suspect-entity Σ 0..* (Complex) A suspected agent causing the adverse event (原因と疑われる薬剤)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-suspect-entity
... contributing-factor Σ 0..* (Complex) Contributing factors suspected to have increased the probability or severity of the adverse event (寄与要因)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-contributing-factor
... mitigating-action Σ 0..* (Complex) Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm (改善措置)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-mitigating-action
... supporting-info Σ 0..* (Complex) Subject medical history or document relevant to this adverse event (被験者の病歴またはこの有害事象に関連する文書)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-supporting-info
... participant 0..* (Complex) Who was involved in the adverse event or the potential adverse event and what they did (関係者)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-participant
... resultingEffect 0..* Reference(Fujitsu Condition Profile | Fujitsu Observation Common Profile | Fujitsu Observation LabResult Profile | Fujitsu Observation Vital Signs Profile | Fujitsu Observation BloodPressure Profile | Fujitsu Observation BMI Profile | Fujitsu Observation BodyHeight Profile | Fujitsu Observation BodyTemperature Profile | Fujitsu Observation BodyWeight Profile | Fujitsu Observation HeadCircum Profile | Fujitsu Observation HeartRate Profile | Fujitsu Observation OxygenSaturation Profile | Fujitsu Observation RespiratoryRate Profile) Effect on the subject due to this event (被験者への影響)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-resulting-effect
... Slices for modifierExtension ?! 1..* Extension Extensions that cannot be ignored (無視できない拡張)
Slice: Unordered, Open by value:url
... modifierExtension:status ?!Σ 1..1 FujitsuStatus in-progress | completed | entered-in-error | unknown (ワークフローの状態)
... identifier Σ 0..1 Identifier Business Identifier for observation (識別子)
... actuality ?!Σ 1..1 code actual (有害事象の全体的な性質)
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.


Required Pattern: actual
... category Σ 0..* CodeableConcept product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment (有害事象のカテゴリ)
Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational.


... event Σ 1..1 CodeableConcept Event or incident that occurred or was averted (イベント)
Binding: AdverseEvent Type (example)
.... extension 0..0
.... Slices for coding Σ 0..* Coding Code defined by a terminology system (イベントのコード)
Slice: Unordered, Open by value:system
..... coding:snomed Σ 0..1 Coding Code defined by a terminology system (イベントを表すコード)
Binding: AdverseEvent Type (required)
...... extension 0..0
...... system Σ 1..1 uri Identity of the terminology system (イベントを定義するコード体系)
Fixed Value: http://snomed.info/sct
...... code Σ 1..1 code Symbol in syntax defined by the system (イベントを表すコード値)
...... display Σ 1..1 string Representation defined by the system (イベントの表示名)
.... text Σ 0..1 string Plain text representation of the concept (イベント)
... subject Σ 1..1 Reference(Fujitsu Patient Profile | Group | Fujitsu Practitioner Profile | RelatedPerson) Subject impacted by event (患者)
... encounter Σ 0..1 Reference(Fujitsu Encounter Profile) Encounter created as part of (関連する外来または入院)
... date Σ 0..1 dateTime When the event occurred (発生日)
... detected Σ 0..1 dateTime When the event was detected (検出日)
... recordedDate Σ 0..1 dateTime When the event was recorded (記録日)
... location Σ 0..1 Reference(Location) Location where adverse event occurred (発生場所)
... seriousness Σ 1..1 CodeableConcept Investigator defined severity of the adverse event, in relation to the subject not the resulting condition (重篤度)
Binding: AdverseEventSeriousness (required)
... severity Σ 0..1 CodeableConcept mild | moderate | severe (深刻度)
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.

... outcome Σ 1..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown (アウトカム)
Binding: Adverse Event Clinical Research Outcomes (required)
... recorder Σ 0..1 Reference(Fujitsu Patient Profile | Fujitsu Practitioner Profile | Fujitsu PractitionerRole Profile | RelatedPerson) Who recorded the adverse event (記録者)
... contributor Σ 0..* Reference(Practitioner | PractitionerRole | Device) Who was involved in the adverse event or the potential adverse event (関与した人)
... study Σ 1..1 Reference(ResearchStudy) AdverseEvent.study (臨床研究の参照)

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
AdverseEvent.actualityrequiredPattern: actual
http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
from the FHIR Standard
AdverseEvent.categoryextensibleAdverseEventCategory
http://hl7.org/fhir/ValueSet/adverse-event-category
from the FHIR Standard
AdverseEvent.eventexampleAdverseEventType
http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-type-vs
AdverseEvent.event.coding:snomedrequiredAdverseEventType
http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-type-vs
AdverseEvent.seriousnessrequiredAdverseEventSeriousness
http://terminology.hl7.org/ValueSet/adverse-event-seriousness
AdverseEvent.severityrequiredAdverseEventSeverity
http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1
from the FHIR Standard
AdverseEvent.outcomerequiredAdverseEventClinicalResearchOutcomes
http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorAdverseEventIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorAdverseEventIf 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-4errorAdverseEventIf 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-5errorAdverseEventIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceAdverseEventA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()
NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..* AdverseEvent Fujitsu Adverse Event Clinical Research (臨床研究有害事象プロファイル)
... id Σ 0..1 id Logical id of this artifact (自動採番される論理ID)
... meta Σ 0..1 Meta Metadata about the resource (リソースのメタデータ)
... text 0..1 Narrative Text summary of the resource, for human interpretation (リソースの概要)
... contained 0..* Resource Contained, inline Resources (リソース内リソース)
... Slices for extension 0..* Extension Additional content defined by implementations (要素の拡張)
Slice: Unordered, Open by value:url
... research-subject-ref 0..1 Reference(ResearchSubject) Research Subject record of subject (被験者の研究対象記録)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-research-subject-ref
... caused-subject-to-discontinue-study 0..1 boolean Adverse event caused subject to discontinue the study (有害事象による被験者の試験中止)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-caused-subject-to-discontinue-study
... seriousness-criteria 0..* (Complex) Criteria reviewed in determining serious adverse event (重篤な有害事象を判断する際に検討される基準)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-seriousness-criteria
... ae-grade 0..1 CodeableConcept The degree of something undesirable, used in oncology trial (グレード)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-ae-grade
Binding: Adverse Event Clinical Research Grades (preferred)
... expected-in-research-study 0..1 boolean Considered likely or probable or anticipated in the research study (予想された結果かどうか)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-expected-in-research-study
... note 0..* Annotation Comment on adverse event (有害事象のコメント)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-note
... resolve-date 0..1 dateTime Adverse Event resolution date (解決日)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-resolve-date
... suspect-entity Σ 0..* (Complex) A suspected agent causing the adverse event (原因と疑われる薬剤)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-suspect-entity
... contributing-factor Σ 0..* (Complex) Contributing factors suspected to have increased the probability or severity of the adverse event (寄与要因)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-contributing-factor
... mitigating-action Σ 0..* (Complex) Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm (改善措置)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-mitigating-action
... supporting-info Σ 0..* (Complex) Subject medical history or document relevant to this adverse event (被験者の病歴またはこの有害事象に関連する文書)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-supporting-info
... participant 0..* (Complex) Who was involved in the adverse event or the potential adverse event and what they did (関係者)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-participant
... resultingEffect 0..* Reference(Fujitsu Condition Profile | Fujitsu Observation Common Profile | Fujitsu Observation LabResult Profile | Fujitsu Observation Vital Signs Profile | Fujitsu Observation BloodPressure Profile | Fujitsu Observation BMI Profile | Fujitsu Observation BodyHeight Profile | Fujitsu Observation BodyTemperature Profile | Fujitsu Observation BodyWeight Profile | Fujitsu Observation HeadCircum Profile | Fujitsu Observation HeartRate Profile | Fujitsu Observation OxygenSaturation Profile | Fujitsu Observation RespiratoryRate Profile) Effect on the subject due to this event (被験者への影響)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-resulting-effect
... Slices for modifierExtension ?! 1..* Extension Extensions that cannot be ignored (無視できない拡張)
Slice: Unordered, Open by value:url
... modifierExtension:status ?!Σ 1..1 FujitsuStatus in-progress | completed | entered-in-error | unknown (ワークフローの状態)
... identifier Σ 0..1 Identifier Business Identifier for observation (識別子)
... actuality ?!Σ 1..1 code actual (有害事象の全体的な性質)
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.


Required Pattern: actual
... category Σ 0..* CodeableConcept product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment (有害事象のカテゴリ)
Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational.


... event Σ 1..1 CodeableConcept Event or incident that occurred or was averted (イベント)
Binding: AdverseEvent Type (example)
.... extension 0..0
.... Slices for coding Σ 0..* Coding Code defined by a terminology system (イベントのコード)
Slice: Unordered, Open by value:system
..... coding:snomed Σ 0..1 Coding Code defined by a terminology system (イベントを表すコード)
Binding: AdverseEvent Type (required)
...... extension 0..0
...... system Σ 1..1 uri Identity of the terminology system (イベントを定義するコード体系)
Fixed Value: http://snomed.info/sct
...... code Σ 1..1 code Symbol in syntax defined by the system (イベントを表すコード値)
...... display Σ 1..1 string Representation defined by the system (イベントの表示名)
.... text Σ 0..1 string Plain text representation of the concept (イベント)
... subject Σ 1..1 Reference(Fujitsu Patient Profile | Group | Fujitsu Practitioner Profile | RelatedPerson) Subject impacted by event (患者)
... encounter Σ 0..1 Reference(Fujitsu Encounter Profile) Encounter created as part of (関連する外来または入院)
... date Σ 0..1 dateTime When the event occurred (発生日)
... detected Σ 0..1 dateTime When the event was detected (検出日)
... recordedDate Σ 0..1 dateTime When the event was recorded (記録日)
... location Σ 0..1 Reference(Location) Location where adverse event occurred (発生場所)
... seriousness Σ 1..1 CodeableConcept Investigator defined severity of the adverse event, in relation to the subject not the resulting condition (重篤度)
Binding: AdverseEventSeriousness (required)
... severity Σ 0..1 CodeableConcept mild | moderate | severe (深刻度)
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.

... outcome Σ 1..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown (アウトカム)
Binding: Adverse Event Clinical Research Outcomes (required)
... recorder Σ 0..1 Reference(Fujitsu Patient Profile | Fujitsu Practitioner Profile | Fujitsu PractitionerRole Profile | RelatedPerson) Who recorded the adverse event (記録者)
... contributor Σ 0..* Reference(Practitioner | PractitionerRole | Device) Who was involved in the adverse event or the potential adverse event (関与した人)
... study Σ 1..1 Reference(ResearchStudy) AdverseEvent.study (臨床研究の参照)

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
AdverseEvent.actualityrequiredPattern: actual
http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
from the FHIR Standard
AdverseEvent.categoryextensibleAdverseEventCategory
http://hl7.org/fhir/ValueSet/adverse-event-category
from the FHIR Standard
AdverseEvent.eventexampleAdverseEventType
http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-type-vs
AdverseEvent.event.coding:snomedrequiredAdverseEventType
http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-type-vs
AdverseEvent.seriousnessrequiredAdverseEventSeriousness
http://terminology.hl7.org/ValueSet/adverse-event-seriousness
AdverseEvent.severityrequiredAdverseEventSeverity
http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1
from the FHIR Standard
AdverseEvent.outcomerequiredAdverseEventClinicalResearchOutcomes
http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes
AdverseEvent.suspectEntity.causality.assessmentexampleAdverseEventCausalityAssessment
http://hl7.org/fhir/ValueSet/adverse-event-causality-assess
from the FHIR Standard
AdverseEvent.suspectEntity.causality.methodexampleAdverseEventCausalityMethod
http://hl7.org/fhir/ValueSet/adverse-event-causality-method
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorAdverseEventIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorAdverseEventIf 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-4errorAdverseEventIf 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-5errorAdverseEventIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceAdverseEventA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from AdverseEvent

Summary

Mandatory: 6 elements(3 nested mandatory elements)
Fixed: 1 element
Prohibited: 12 elements

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of AdverseEvent.event.coding

Differential View

This structure is derived from AdverseEvent

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..* AdverseEvent Fujitsu Adverse Event Clinical Research (臨床研究有害事象プロファイル)
... id 0..1 id Logical id of this artifact (自動採番される論理ID)
... meta 0..1 Meta Metadata about the resource (リソースのメタデータ)
... implicitRules 0..0
... language 0..0
... text 0..1 Narrative Text summary of the resource, for human interpretation (リソースの概要)
... contained 0..* Resource Contained, inline Resources (リソース内リソース)
... Slices for extension 0..* Extension Additional content defined by implementations (要素の拡張)
Slice: Unordered, Open by value:url
... research-subject-ref 0..1 Reference(ResearchSubject) Research Subject record of subject (被験者の研究対象記録)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-research-subject-ref
... caused-subject-to-discontinue-study 0..1 boolean Adverse event caused subject to discontinue the study (有害事象による被験者の試験中止)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-caused-subject-to-discontinue-study
... seriousness-criteria 0..* (Complex) Criteria reviewed in determining serious adverse event (重篤な有害事象を判断する際に検討される基準)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-seriousness-criteria
... ae-grade 0..1 CodeableConcept The degree of something undesirable, used in oncology trial (グレード)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-ae-grade
Binding: Adverse Event Clinical Research Grades (preferred)
... expected-in-research-study 0..1 boolean Considered likely or probable or anticipated in the research study (予想された結果かどうか)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-expected-in-research-study
... note 0..* Annotation Comment on adverse event (有害事象のコメント)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-note
... resolve-date 0..1 dateTime Adverse Event resolution date (解決日)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-resolve-date
... suspect-entity Σ 0..* (Complex) A suspected agent causing the adverse event (原因と疑われる薬剤)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-suspect-entity
... contributing-factor Σ 0..* (Complex) Contributing factors suspected to have increased the probability or severity of the adverse event (寄与要因)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-contributing-factor
... mitigating-action Σ 0..* (Complex) Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm (改善措置)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-mitigating-action
... supporting-info Σ 0..* (Complex) Subject medical history or document relevant to this adverse event (被験者の病歴またはこの有害事象に関連する文書)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-supporting-info
... participant 0..* (Complex) Who was involved in the adverse event or the potential adverse event and what they did (関係者)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-participant
... resultingEffect 0..* Reference(Fujitsu Condition Profile | Fujitsu Observation Common Profile | Fujitsu Observation LabResult Profile | Fujitsu Observation Vital Signs Profile | Fujitsu Observation BloodPressure Profile | Fujitsu Observation BMI Profile | Fujitsu Observation BodyHeight Profile | Fujitsu Observation BodyTemperature Profile | Fujitsu Observation BodyWeight Profile | Fujitsu Observation HeadCircum Profile | Fujitsu Observation HeartRate Profile | Fujitsu Observation OxygenSaturation Profile | Fujitsu Observation RespiratoryRate Profile) Effect on the subject due to this event (被験者への影響)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-resulting-effect
... Slices for modifierExtension 1..* Extension Extensions that cannot be ignored (無視できない拡張)
Slice: Unordered, Open by value:url
... modifierExtension:status Σ 1..1 FujitsuStatus in-progress | completed | entered-in-error | unknown (ワークフローの状態)
... identifier 0..1 Identifier Business Identifier for observation (識別子)
... actuality 1..1 code actual (有害事象の全体的な性質)
Required Pattern: actual
... category 0..* CodeableConcept product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment (有害事象のカテゴリ)
... event 1..1 CodeableConcept Event or incident that occurred or was averted (イベント)
Binding: AdverseEvent Type (example)
.... id 0..0
.... extension 0..0
.... Slices for coding 0..* Coding Code defined by a terminology system (イベントのコード)
Slice: Unordered, Open by value:system
..... coding:snomed 0..1 Coding Code defined by a terminology system (イベントを表すコード)
Binding: AdverseEvent Type (required)
...... id 0..0
...... extension 0..0
...... system 1..1 uri Identity of the terminology system (イベントを定義するコード体系)
Fixed Value: http://snomed.info/sct
...... version 0..0
...... code 1..1 code Symbol in syntax defined by the system (イベントを表すコード値)
...... display 1..1 string Representation defined by the system (イベントの表示名)
...... userSelected 0..0
.... text 0..1 string Plain text representation of the concept (イベント)
... subject 1..1 Reference(Fujitsu Patient Profile | Group | Fujitsu Practitioner Profile | RelatedPerson) Subject impacted by event (患者)
... encounter 0..1 Reference(Fujitsu Encounter Profile) Encounter created as part of (関連する外来または入院)
... date 0..1 dateTime When the event occurred (発生日)
... detected 0..1 dateTime When the event was detected (検出日)
... recordedDate 0..1 dateTime When the event was recorded (記録日)
... resultingCondition 0..0
... location 0..1 Reference(Location) Location where adverse event occurred (発生場所)
... seriousness 1..1 CodeableConcept Investigator defined severity of the adverse event, in relation to the subject not the resulting condition (重篤度)
Binding: AdverseEventSeriousness (required)
... severity 0..1 CodeableConcept mild | moderate | severe (深刻度)
... outcome 1..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown (アウトカム)
Binding: Adverse Event Clinical Research Outcomes (required)
... recorder 0..1 Reference(Fujitsu Patient Profile | Fujitsu Practitioner Profile | Fujitsu PractitionerRole Profile | RelatedPerson) Who recorded the adverse event (記録者)
... contributor 0..* Reference(Practitioner | PractitionerRole | Device) Who was involved in the adverse event or the potential adverse event (関与した人)
... suspectEntity 0..0
... subjectMedicalHistory 0..0
... referenceDocument 0..0
... study 1..1 Reference(ResearchStudy) AdverseEvent.study (臨床研究の参照)

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
AdverseEvent.eventexampleAdverseEventType
http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-type-vs
AdverseEvent.event.coding:snomedrequiredAdverseEventType
http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-type-vs
AdverseEvent.seriousnessrequiredAdverseEventSeriousness
http://terminology.hl7.org/ValueSet/adverse-event-seriousness
AdverseEvent.outcomerequiredAdverseEventClinicalResearchOutcomes
http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..* AdverseEvent Fujitsu Adverse Event Clinical Research (臨床研究有害事象プロファイル)
... id Σ 0..1 id Logical id of this artifact (自動採番される論理ID)
... meta Σ 0..1 Meta Metadata about the resource (リソースのメタデータ)
... text 0..1 Narrative Text summary of the resource, for human interpretation (リソースの概要)
... contained 0..* Resource Contained, inline Resources (リソース内リソース)
... Slices for extension 0..* Extension Additional content defined by implementations (要素の拡張)
Slice: Unordered, Open by value:url
... research-subject-ref 0..1 Reference(ResearchSubject) Research Subject record of subject (被験者の研究対象記録)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-research-subject-ref
... caused-subject-to-discontinue-study 0..1 boolean Adverse event caused subject to discontinue the study (有害事象による被験者の試験中止)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-caused-subject-to-discontinue-study
... seriousness-criteria 0..* (Complex) Criteria reviewed in determining serious adverse event (重篤な有害事象を判断する際に検討される基準)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-seriousness-criteria
... ae-grade 0..1 CodeableConcept The degree of something undesirable, used in oncology trial (グレード)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-ae-grade
Binding: Adverse Event Clinical Research Grades (preferred)
... expected-in-research-study 0..1 boolean Considered likely or probable or anticipated in the research study (予想された結果かどうか)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-expected-in-research-study
... note 0..* Annotation Comment on adverse event (有害事象のコメント)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-note
... resolve-date 0..1 dateTime Adverse Event resolution date (解決日)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-resolve-date
... suspect-entity Σ 0..* (Complex) A suspected agent causing the adverse event (原因と疑われる薬剤)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-suspect-entity
... contributing-factor Σ 0..* (Complex) Contributing factors suspected to have increased the probability or severity of the adverse event (寄与要因)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-contributing-factor
... mitigating-action Σ 0..* (Complex) Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm (改善措置)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-mitigating-action
... supporting-info Σ 0..* (Complex) Subject medical history or document relevant to this adverse event (被験者の病歴またはこの有害事象に関連する文書)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-supporting-info
... participant 0..* (Complex) Who was involved in the adverse event or the potential adverse event and what they did (関係者)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-participant
... resultingEffect 0..* Reference(Fujitsu Condition Profile | Fujitsu Observation Common Profile | Fujitsu Observation LabResult Profile | Fujitsu Observation Vital Signs Profile | Fujitsu Observation BloodPressure Profile | Fujitsu Observation BMI Profile | Fujitsu Observation BodyHeight Profile | Fujitsu Observation BodyTemperature Profile | Fujitsu Observation BodyWeight Profile | Fujitsu Observation HeadCircum Profile | Fujitsu Observation HeartRate Profile | Fujitsu Observation OxygenSaturation Profile | Fujitsu Observation RespiratoryRate Profile) Effect on the subject due to this event (被験者への影響)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-resulting-effect
... Slices for modifierExtension ?! 1..* Extension Extensions that cannot be ignored (無視できない拡張)
Slice: Unordered, Open by value:url
... modifierExtension:status ?!Σ 1..1 FujitsuStatus in-progress | completed | entered-in-error | unknown (ワークフローの状態)
... identifier Σ 0..1 Identifier Business Identifier for observation (識別子)
... actuality ?!Σ 1..1 code actual (有害事象の全体的な性質)
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.


Required Pattern: actual
... category Σ 0..* CodeableConcept product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment (有害事象のカテゴリ)
Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational.


... event Σ 1..1 CodeableConcept Event or incident that occurred or was averted (イベント)
Binding: AdverseEvent Type (example)
.... extension 0..0
.... Slices for coding Σ 0..* Coding Code defined by a terminology system (イベントのコード)
Slice: Unordered, Open by value:system
..... coding:snomed Σ 0..1 Coding Code defined by a terminology system (イベントを表すコード)
Binding: AdverseEvent Type (required)
...... extension 0..0
...... system Σ 1..1 uri Identity of the terminology system (イベントを定義するコード体系)
Fixed Value: http://snomed.info/sct
...... code Σ 1..1 code Symbol in syntax defined by the system (イベントを表すコード値)
...... display Σ 1..1 string Representation defined by the system (イベントの表示名)
.... text Σ 0..1 string Plain text representation of the concept (イベント)
... subject Σ 1..1 Reference(Fujitsu Patient Profile | Group | Fujitsu Practitioner Profile | RelatedPerson) Subject impacted by event (患者)
... encounter Σ 0..1 Reference(Fujitsu Encounter Profile) Encounter created as part of (関連する外来または入院)
... date Σ 0..1 dateTime When the event occurred (発生日)
... detected Σ 0..1 dateTime When the event was detected (検出日)
... recordedDate Σ 0..1 dateTime When the event was recorded (記録日)
... location Σ 0..1 Reference(Location) Location where adverse event occurred (発生場所)
... seriousness Σ 1..1 CodeableConcept Investigator defined severity of the adverse event, in relation to the subject not the resulting condition (重篤度)
Binding: AdverseEventSeriousness (required)
... severity Σ 0..1 CodeableConcept mild | moderate | severe (深刻度)
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.

... outcome Σ 1..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown (アウトカム)
Binding: Adverse Event Clinical Research Outcomes (required)
... recorder Σ 0..1 Reference(Fujitsu Patient Profile | Fujitsu Practitioner Profile | Fujitsu PractitionerRole Profile | RelatedPerson) Who recorded the adverse event (記録者)
... contributor Σ 0..* Reference(Practitioner | PractitionerRole | Device) Who was involved in the adverse event or the potential adverse event (関与した人)
... study Σ 1..1 Reference(ResearchStudy) AdverseEvent.study (臨床研究の参照)

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
AdverseEvent.actualityrequiredPattern: actual
http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
from the FHIR Standard
AdverseEvent.categoryextensibleAdverseEventCategory
http://hl7.org/fhir/ValueSet/adverse-event-category
from the FHIR Standard
AdverseEvent.eventexampleAdverseEventType
http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-type-vs
AdverseEvent.event.coding:snomedrequiredAdverseEventType
http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-type-vs
AdverseEvent.seriousnessrequiredAdverseEventSeriousness
http://terminology.hl7.org/ValueSet/adverse-event-seriousness
AdverseEvent.severityrequiredAdverseEventSeverity
http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1
from the FHIR Standard
AdverseEvent.outcomerequiredAdverseEventClinicalResearchOutcomes
http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorAdverseEventIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorAdverseEventIf 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-4errorAdverseEventIf 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-5errorAdverseEventIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceAdverseEventA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..* AdverseEvent Fujitsu Adverse Event Clinical Research (臨床研究有害事象プロファイル)
... id Σ 0..1 id Logical id of this artifact (自動採番される論理ID)
... meta Σ 0..1 Meta Metadata about the resource (リソースのメタデータ)
... text 0..1 Narrative Text summary of the resource, for human interpretation (リソースの概要)
... contained 0..* Resource Contained, inline Resources (リソース内リソース)
... Slices for extension 0..* Extension Additional content defined by implementations (要素の拡張)
Slice: Unordered, Open by value:url
... research-subject-ref 0..1 Reference(ResearchSubject) Research Subject record of subject (被験者の研究対象記録)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-research-subject-ref
... caused-subject-to-discontinue-study 0..1 boolean Adverse event caused subject to discontinue the study (有害事象による被験者の試験中止)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-caused-subject-to-discontinue-study
... seriousness-criteria 0..* (Complex) Criteria reviewed in determining serious adverse event (重篤な有害事象を判断する際に検討される基準)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-seriousness-criteria
... ae-grade 0..1 CodeableConcept The degree of something undesirable, used in oncology trial (グレード)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-ae-grade
Binding: Adverse Event Clinical Research Grades (preferred)
... expected-in-research-study 0..1 boolean Considered likely or probable or anticipated in the research study (予想された結果かどうか)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-expected-in-research-study
... note 0..* Annotation Comment on adverse event (有害事象のコメント)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-note
... resolve-date 0..1 dateTime Adverse Event resolution date (解決日)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-resolve-date
... suspect-entity Σ 0..* (Complex) A suspected agent causing the adverse event (原因と疑われる薬剤)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-suspect-entity
... contributing-factor Σ 0..* (Complex) Contributing factors suspected to have increased the probability or severity of the adverse event (寄与要因)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-contributing-factor
... mitigating-action Σ 0..* (Complex) Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm (改善措置)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-mitigating-action
... supporting-info Σ 0..* (Complex) Subject medical history or document relevant to this adverse event (被験者の病歴またはこの有害事象に関連する文書)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-supporting-info
... participant 0..* (Complex) Who was involved in the adverse event or the potential adverse event and what they did (関係者)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-participant
... resultingEffect 0..* Reference(Fujitsu Condition Profile | Fujitsu Observation Common Profile | Fujitsu Observation LabResult Profile | Fujitsu Observation Vital Signs Profile | Fujitsu Observation BloodPressure Profile | Fujitsu Observation BMI Profile | Fujitsu Observation BodyHeight Profile | Fujitsu Observation BodyTemperature Profile | Fujitsu Observation BodyWeight Profile | Fujitsu Observation HeadCircum Profile | Fujitsu Observation HeartRate Profile | Fujitsu Observation OxygenSaturation Profile | Fujitsu Observation RespiratoryRate Profile) Effect on the subject due to this event (被験者への影響)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-resulting-effect
... Slices for modifierExtension ?! 1..* Extension Extensions that cannot be ignored (無視できない拡張)
Slice: Unordered, Open by value:url
... modifierExtension:status ?!Σ 1..1 FujitsuStatus in-progress | completed | entered-in-error | unknown (ワークフローの状態)
... identifier Σ 0..1 Identifier Business Identifier for observation (識別子)
... actuality ?!Σ 1..1 code actual (有害事象の全体的な性質)
Binding: AdverseEventActuality (required): Overall nature of the adverse event, e.g. real or potential.


Required Pattern: actual
... category Σ 0..* CodeableConcept product-problem | product-quality | product-use-error | wrong-dose | incorrect-prescribing-information | wrong-technique | wrong-route-of-administration | wrong-rate | wrong-duration | wrong-time | expired-drug | medical-device-use-error | problem-different-manufacturer | unsafe-physical-environment (有害事象のカテゴリ)
Binding: AdverseEventCategory (extensible): Overall categorization of the event, e.g. product-related or situational.


... event Σ 1..1 CodeableConcept Event or incident that occurred or was averted (イベント)
Binding: AdverseEvent Type (example)
.... extension 0..0
.... Slices for coding Σ 0..* Coding Code defined by a terminology system (イベントのコード)
Slice: Unordered, Open by value:system
..... coding:snomed Σ 0..1 Coding Code defined by a terminology system (イベントを表すコード)
Binding: AdverseEvent Type (required)
...... extension 0..0
...... system Σ 1..1 uri Identity of the terminology system (イベントを定義するコード体系)
Fixed Value: http://snomed.info/sct
...... code Σ 1..1 code Symbol in syntax defined by the system (イベントを表すコード値)
...... display Σ 1..1 string Representation defined by the system (イベントの表示名)
.... text Σ 0..1 string Plain text representation of the concept (イベント)
... subject Σ 1..1 Reference(Fujitsu Patient Profile | Group | Fujitsu Practitioner Profile | RelatedPerson) Subject impacted by event (患者)
... encounter Σ 0..1 Reference(Fujitsu Encounter Profile) Encounter created as part of (関連する外来または入院)
... date Σ 0..1 dateTime When the event occurred (発生日)
... detected Σ 0..1 dateTime When the event was detected (検出日)
... recordedDate Σ 0..1 dateTime When the event was recorded (記録日)
... location Σ 0..1 Reference(Location) Location where adverse event occurred (発生場所)
... seriousness Σ 1..1 CodeableConcept Investigator defined severity of the adverse event, in relation to the subject not the resulting condition (重篤度)
Binding: AdverseEventSeriousness (required)
... severity Σ 0..1 CodeableConcept mild | moderate | severe (深刻度)
Binding: AdverseEventSeverity (required): The severity of the adverse event itself, in direct relation to the subject.

... outcome Σ 1..1 CodeableConcept resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown (アウトカム)
Binding: Adverse Event Clinical Research Outcomes (required)
... recorder Σ 0..1 Reference(Fujitsu Patient Profile | Fujitsu Practitioner Profile | Fujitsu PractitionerRole Profile | RelatedPerson) Who recorded the adverse event (記録者)
... contributor Σ 0..* Reference(Practitioner | PractitionerRole | Device) Who was involved in the adverse event or the potential adverse event (関与した人)
... study Σ 1..1 Reference(ResearchStudy) AdverseEvent.study (臨床研究の参照)

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
AdverseEvent.actualityrequiredPattern: actual
http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1
from the FHIR Standard
AdverseEvent.categoryextensibleAdverseEventCategory
http://hl7.org/fhir/ValueSet/adverse-event-category
from the FHIR Standard
AdverseEvent.eventexampleAdverseEventType
http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-type-vs
AdverseEvent.event.coding:snomedrequiredAdverseEventType
http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-type-vs
AdverseEvent.seriousnessrequiredAdverseEventSeriousness
http://terminology.hl7.org/ValueSet/adverse-event-seriousness
AdverseEvent.severityrequiredAdverseEventSeverity
http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1
from the FHIR Standard
AdverseEvent.outcomerequiredAdverseEventClinicalResearchOutcomes
http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes
AdverseEvent.suspectEntity.causality.assessmentexampleAdverseEventCausalityAssessment
http://hl7.org/fhir/ValueSet/adverse-event-causality-assess
from the FHIR Standard
AdverseEvent.suspectEntity.causality.methodexampleAdverseEventCausalityMethod
http://hl7.org/fhir/ValueSet/adverse-event-causality-method
from the FHIR Standard

Constraints

IdGradePath(s)DetailsRequirements
dom-2errorAdverseEventIf the resource is contained in another resource, it SHALL NOT contain nested Resources
: contained.contained.empty()
dom-3errorAdverseEventIf 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-4errorAdverseEventIf 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-5errorAdverseEventIf a resource is contained in another resource, it SHALL NOT have a security label
: contained.meta.security.empty()
dom-6best practiceAdverseEventA resource should have narrative for robust management
: text.`div`.exists()
ele-1error**ALL** elementsAll FHIR elements must have a @value or children
: hasValue() or (children().count() > id.count())
ext-1error**ALL** extensionsMust have either extensions or value[x], not both
: extension.exists() != value.exists()

This structure is derived from AdverseEvent

Summary

Mandatory: 6 elements(3 nested mandatory elements)
Fixed: 1 element
Prohibited: 12 elements

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of AdverseEvent.event.coding

 

Other representations of profile: CSV, Excel, Schematron