NameFlagsCard.TypeDescription & Constraintsdoco
.. AdverseEvent 0..*AdverseEventFujitsu Adverse Event Clinical Research (臨床研究有害事象プロファイル)
... id 0..1idLogical id of this artifact (自動採番される論理ID)
... meta 0..1MetaMetadata about the resource (リソースのメタデータ)
... implicitRules 0..0
... language 0..0
... text 0..1NarrativeText summary of the resource, for human interpretation (リソースの概要)
... contained 0..*ResourceContained, inline Resources (リソース内リソース)
... Slices for extension 0..*ExtensionAdditional content defined by implementations (要素の拡張)
Slice: Unordered, Open by value:url
... research-subject-ref 0..1Reference(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..1booleanAdverse 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..1CodeableConceptThe 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..1booleanConsidered 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..*AnnotationComment 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..1dateTimeAdverse Event resolution date (解決日)
URL: http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-resolve-date
... suspect-entity Σ0..*(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 Σ0..*(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 Σ0..*(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 Σ0..*(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..*ExtensionExtensions that cannot be ignored (無視できない拡張)
Slice: Unordered, Open by value:url
... modifierExtension:status Σ1..1FujitsuStatusin-progress | completed | entered-in-error | unknown (ワークフローの状態)
... identifier 0..1IdentifierBusiness Identifier for observation (識別子)
... actuality 1..1codeactual (有害事象の全体的な性質)
Required Pattern: actual
... category 0..*CodeableConceptproduct-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..1CodeableConceptEvent 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..*CodingCode defined by a terminology system (イベントのコード)
Slice: Unordered, Open by value:system
..... coding:snomed 0..1CodingCode 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..1uriIdentity 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..1codeSymbol in syntax defined by the system (イベントを表すコード値)
...... display 1..1stringRepresentation defined by the system (イベントの表示名)
...... userSelected 0..0
.... text 0..1stringPlain text representation of the concept (イベント)
... subject 1..1Reference(Fujitsu Patient Profile | Group | Fujitsu Practitioner Profile | RelatedPerson)Subject impacted by event (患者)
... encounter 0..1Reference(Fujitsu Encounter Profile)Encounter created as part of (関連する外来または入院)
... date 0..1dateTimeWhen the event occurred (発生日)
... detected 0..1dateTimeWhen the event was detected (検出日)
... recordedDate 0..1dateTimeWhen the event was recorded (記録日)
... resultingCondition 0..0
... location 0..1Reference(Location)Location where adverse event occurred (発生場所)
... seriousness 1..1CodeableConceptInvestigator defined severity of the adverse event, in relation to the subject not the resulting condition (重篤度)
Binding: AdverseEventSeriousness (required)
... severity 0..1CodeableConceptmild | moderate | severe (深刻度)
... outcome 1..1CodeableConceptresolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown (アウトカム)
Binding: Adverse Event Clinical Research Outcomes (required)
... recorder 0..1Reference(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..1Reference(ResearchStudy)AdverseEvent.study (臨床研究の参照)

doco Documentation for this format
 <status value="active"/> <experimental value="false"/> <date value="2025-12-04T01:48:39+00:00"/> <publisher value="Fujitsu"/> <contact> <name value="Fujitsu"/> <telecom> <system value="url"/> <value value="https://hlpf.global.fujitsu.com/top/"/> </telecom> </contact> <description value="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。"/> <copyright value="Copyright 2022 FUJITSU LIMITED"/> <fhirVersion value="4.0.1"/> <mapping> <identity value="w5"/> <uri value="http://hl7.org/fhir/fivews"/> <name value="FiveWs Pattern Mapping"/> </mapping> <mapping> <identity value="rim"/> <uri value="http://hl7.org/v3"/> <name value="RIM Mapping"/> </mapping> <kind value="resource"/> <abstract value="false"/> <type value="AdverseEvent"/> <baseDefinition value="http://hl7.org/fhir/StructureDefinition/AdverseEvent"/> <derivation value="constraint"/> <snapshot> <element id="AdverseEvent"> <path value="AdverseEvent"/> <short value="Fujitsu Adverse Event Clinical Research (臨床研究有害事象プロファイル)"/> <definition value="This profile defines the patient's adverse event clinical research. "/> <alias value="AE"/> <min value="0"/> <max value="*"/> <base> <path value="AdverseEvent"/> <min value="0"/> <max value="*"/> </base> <constraint> <key value="dom-2"/> <severity value="error"/> <human value="If the resource is contained in another resource, it SHALL NOT contain nested Resources"/> <expression value="contained.contained.empty()"/> <xpath value="not(parent::f:contained and f:contained)"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <constraint> <key value="dom-3"/> <severity value="error"/> <human value="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"/> <expression value="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()"/> <xpath value="not(exists(for $id in f:contained/*/f:id/@value return $contained[not(parent::*/descendant::f:reference/@value=concat('#', $contained/*/id/@value) or descendant::f:reference[@value='#'])]))"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <constraint> <key value="dom-4"/> <severity value="error"/> <human value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated"/> <expression value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"/> <xpath value="not(exists(f:contained/*/f:meta/f:versionId)) and not(exists(f:contained/*/f:meta/f:lastUpdated))"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <constraint> <key value="dom-5"/> <severity value="error"/> <human value="If a resource is contained in another resource, it SHALL NOT have a security label"/> <expression value="contained.meta.security.empty()"/> <xpath value="not(exists(f:contained/*/f:meta/f:security))"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <constraint> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice"> <valueBoolean value="true"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation"> <valueMarkdown value="When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."/> </extension> <key value="dom-6"/> <severity value="warning"/> <human value="A resource should have narrative for robust management"/> <expression value="text.`div`.exists()"/> <xpath value="exists(f:text/h:div)"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="Entity. Role, or Act"/> </mapping> </element> <element id="AdverseEvent.id"> <path value="AdverseEvent.id"/> <short value="Logical id of this artifact (自動採番される論理ID)"/> <definition value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes."/> <comment value="The only time that a resource does not have an id is when it is being submitted to the server using a create operation."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.id"/> <min value="0"/> <max value="1"/> </base> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="id"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.meta"> <path value="AdverseEvent.meta"/> <short value="Metadata about the resource (リソースのメタデータ)"/> <definition value="The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.meta"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Meta"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.implicitRules"> <path value="AdverseEvent.implicitRules"/> <short value="A set of rules under which this content was created"/> <definition value="A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc."/> <comment value="Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc."/> <min value="0"/> <max value="0"/> <base> <path value="Resource.implicitRules"/> <min value="0"/> <max value="1"/> </base> <type> <code value="uri"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="true"/> <isModifierReason value="This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation"/> <isSummary value="true"/> </element> <element id="AdverseEvent.language"> <path value="AdverseEvent.language"/> <short value="Language of the resource content"/> <definition value="The base language in which the resource is written."/> <comment value="Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute)."/> <min value="0"/> <max value="0"/> <base> <path value="Resource.language"/> <min value="0"/> <max value="1"/> </base> <type> <code value="code"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-maxValueSet"> <valueCanonical value="http://hl7.org/fhir/ValueSet/all-languages"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="Language"/> </extension> <strength value="preferred"/> <description value="A human language."/> <valueSet value="http://hl7.org/fhir/ValueSet/languages"/> </binding> </element> <element id="AdverseEvent.text"> <path value="AdverseEvent.text"/> <short value="Text summary of the resource, for human interpretation (リソースの概要)"/> <definition value="A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety."/> <comment value="Contained resources do not have narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later."/> <alias value="narrative"/> <alias value="html"/> <alias value="xhtml"/> <alias value="display"/> <min value="0"/> <max value="1"/> <base> <path value="DomainResource.text"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Narrative"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="Act.text?"/> </mapping> </element> <element id="AdverseEvent.contained"> <path value="AdverseEvent.contained"/> <short value="Contained, inline Resources (リソース内リソース)"/> <definition value="These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope."/> <comment value="This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags In their meta elements, but SHALL NOT have security labels."/> <alias value="inline resources"/> <alias value="anonymous resources"/> <alias value="contained resources"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.contained"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Resource"/> </type> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="AdverseEvent.extension"> <path value="AdverseEvent.extension"/> <slicing> <discriminator> <type value="value"/> <path value="url"/> </discriminator> <ordered value="false"/> <rules value="open"/> </slicing> <short value="Additional content defined by implementations (要素の拡張)"/> <definition value="An Extension"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="AdverseEvent.extension:research-subject-ref"> <path value="AdverseEvent.extension"/> <sliceName value="research-subject-ref"/> <short value="Research Subject record of subject (被験者の研究対象記録)"/> <definition value="Communicates Research Subject related metadata. 研究テーマに関連するメタデータの参照。"/> <min value="0"/> <max value="1"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-research-subject-ref"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> </element> <element id="AdverseEvent.extension:caused-subject-to-discontinue-study"> <path value="AdverseEvent.extension"/> <sliceName value="caused-subject-to-discontinue-study"/> <short value="Adverse event caused subject to discontinue the study (有害事象による被験者の試験中止)"/> <definition value="Indicates if the subject discontinued the study due to the adverse event. 被験者が有害事象により試験を中止した場合を示す。"/> <min value="0"/> <max value="1"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-caused-subject-to-discontinue-study"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> </element> <element id="AdverseEvent.extension:seriousness-criteria"> <path value="AdverseEvent.extension"/> <sliceName value="seriousness-criteria"/> <short value="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)"/> <definition value="Element to capture the presence or absence of specific factors (criteria) associated with serious adverse events. 重篤な有害事象に関連する特定の因子（基準）の有無を把握するための要素。"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-seriousness-criteria"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> </element> <element id="AdverseEvent.extension:ae-grade"> <path value="AdverseEvent.extension"/> <sliceName value="ae-grade"/> <short value="The degree of something undesirable, used in oncology trial (グレード)"/> <definition value="For cancer related trials, severity is represented as a grade. Describes the grade of the adverse event, in relation to the subject not the resulting condition. In the context of clinical research, it is the investigator’s assessment of severity, in oncology related trials this is reported as grade. がん関連の試験では、重症度はグレードで表される。有害事象のグレードは、結果として生じた状態ではなく、被験者との関係で記述される。臨床研究の文脈では、治験責任医師による重症度の評価であり、がん関連試験ではグレードとして報告される。"/> <min value="0"/> <max value="1"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-ae-grade"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> </element> <element id="AdverseEvent.extension:expected-in-research-study"> <path value="AdverseEvent.extension"/> <sliceName value="expected-in-research-study"/> <short value="Considered likely or probable or anticipated in the research study (予想された結果かどうか)"/> <definition value="Considered likely or probable or anticipated in the research study. Whether the reported event matches any of the outcomes for the patient that are considered by the study as known or likely. 調査研究で、予想される事象が報告されているかどうか。その事象が、治験で既知のもの、または患者の転帰と一致する可能性が高いかどうか。"/> <min value="0"/> <max value="1"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-expected-in-research-study"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> </element> <element id="AdverseEvent.extension:note"> <path value="AdverseEvent.extension"/> <sliceName value="note"/> <short value="Comment on adverse event (有害事象のコメント)"/> <definition value="Comments made about the adverse event by the performer, subject or other participants. 実施者、被験者、その他の参加者による有害事象に関するコメント。"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-note"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> </element> <element id="AdverseEvent.extension:resolve-date"> <path value="AdverseEvent.extension"/> <sliceName value="resolve-date"/> <short value="Adverse Event resolution date (解決日)"/> <definition value="The date the adverse event was resolved. 有害事象が解決された日時。"/> <min value="0"/> <max value="1"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-resolve-date"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> </element> <element id="AdverseEvent.extension:suspect-entity"> <path value="AdverseEvent.extension"/> <sliceName value="suspect-entity"/> <short value="A suspected agent causing the adverse event (原因と疑われる薬剤)"/> <definition value="Describes an entity that is suspected to have caused the adverse event. (有害事象を引き起こしたと疑われる因子を記述する。)"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-suspect-entity"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.extension:contributing-factor"> <path value="AdverseEvent.extension"/> <sliceName value="contributing-factor"/> <short value="Contributing factors suspected to have increased the probability or severity of the adverse event (寄与要因)"/> <definition value="A contributing factors suspected to have increased the probability or severity of the adverse event. (有害事象の発生確率または重症度を高めたと疑われる要因)"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-contributing-factor"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.extension:mitigating-action"> <path value="AdverseEvent.extension"/> <sliceName value="mitigating-action"/> <short value="Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm (改善措置)"/> <definition value="The ameliorating action taken after the adverse event occurred in order to reduce the extent of harm. (有害事象の発生後、被害の程度を軽減するために取られた改善措置)"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-mitigating-action"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.extension:supporting-info"> <path value="AdverseEvent.extension"/> <sliceName value="supporting-info"/> <short value="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)"/> <definition value="Relevant past history for the subject. In a clinical care context, an example being a patient had an adverse event following a penicillin administration and the patient had a previously documented penicillin allergy. In a clinical trials context, an example is a bunion or rash that was present prior to the study. Additionally, the supporting item can be a document that is relevant to this instance of the adverse event that is not part of the subject's medical history. For example, a clinical note, staff list, or material safety data sheet (MSDS). Supporting information is not a contributing factor, preventive action, or mitigating action. 被験者に関連する過去の病歴。臨床医療の文脈では、例えば、患者がペニシリン投与後に有害 事象を起こし、その患者が以前にペニシリンアレルギーを記録されたことが ある。臨床試験の文脈では、試験前に存在した外反母趾や発疹が例となる。さらに、補助項目は、被験者の病歴の一部ではない、有害事象のこの例に関連する 文書とすることができる。例えば、臨床記録、スタッフリスト、物質安全性データシート（MSDS）な ど。裏付け情報は、要因、予防措置、緩和措置ではない。"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-supporting-info"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.extension:participant"> <path value="AdverseEvent.extension"/> <sliceName value="participant"/> <short value="Who was involved in the adverse event or the potential adverse event and what they did (関係者)"/> <definition value="Indicates who or what participated in the adverse event and how they were involved. 誰が、何が、どのように有害事象に関与したかを示す"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-participant"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> </element> <element id="AdverseEvent.extension:resultingEffect"> <path value="AdverseEvent.extension"/> <sliceName value="resultingEffect"/> <short value="Effect on the subject due to this event (被験者への影響)"/> <definition value="Information about the condition that occurred as a result of the adverse event. 有害事象の結果として発生した状態に関する情報。"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-resulting-effect"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> </element> <element id="AdverseEvent.modifierExtension"> <path value="AdverseEvent.modifierExtension"/> <slicing> <discriminator> <type value="value"/> <path value="url"/> </discriminator> <ordered value="false"/> <rules value="open"/> </slicing> <short value="Extensions that cannot be ignored (無視できない拡張)"/> <definition value="An Extension"/> <min value="1"/> <max value="*"/> <base> <path value="DomainResource.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them"/> <isSummary value="false"/> </element> <element id="AdverseEvent.modifierExtension:status"> <path value="AdverseEvent.modifierExtension"/> <sliceName value="status"/> <short value="in-progress | completed | entered-in-error | unknown (ワークフローの状態)"/> <definition value="The current state of the adverse event or potential adverse event. (いかなる規制または品質機関への事象の報告でもない。 これは患者の状態の結果ではない。)"/> <comment value="This is not the reporting of the event to any regulatory or quality organization. This is not the outcome of the patient's condition."/> <min value="1"/> <max value="1"/> <base> <path value="DomainResource.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> <profile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-status"/> </type> <condition value="ele-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), 'value')])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="true"/> <isModifierReason value="This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid"/> <isSummary value="true"/> </element> <element id="AdverseEvent.identifier"> <path value="AdverseEvent.identifier"/> <short value="Business Identifier for observation (識別子)"/> <definition value="Business identifiers assigned to this adverse event by the performer or other systems which remain constant as the resource is updated and propagates from server to server."/> <comment value="This is a business identifier, not a resource identifier (see [discussion](http://hl7.org/fhir/R4/resource.html#identifiers)). It is best practice for the identifier to only appear on a single resource instance, however business practices may occasionally dictate that multiple resource instances with the same identifier can exist - possibly even with different resource types. For example, multiple Patient and a Person resource instance might share the same social insurance number."/> <requirements value="Allows identification of the adverse event as it is known by various participating systems and in a way that remains consistent across servers."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.identifier"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Identifier"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.actuality"> <path value="AdverseEvent.actuality"/> <short value="actual (有害事象の全体的な性質)"/> <definition value="Whether the event actually happened, or just had the potential to. Note that this is independent of whether anyone was affected or harmed or how severely."/> <min value="1"/> <max value="1"/> <base> <path value="AdverseEvent.actuality"/> <min value="1"/> <max value="1"/> </base> <type> <code value="code"/> </type> <patternCode value="actual"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="true"/> <isModifierReason value="This element is labeled as a modifier because it has a potential code that indicates the adverse event did not actually happen."/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventActuality"/> </extension> <strength value="required"/> <description value="Overall nature of the adverse event, e.g. real or potential."/> <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-actuality|4.0.1"/> </binding> <mapping> <identity value="w5"/> <map value="FiveWs.class"/> </mapping> </element> <element id="AdverseEvent.category"> <path value="AdverseEvent.category"/> <short value="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)"/> <definition value="The overall type of event, intended for search and filtering purposes."/> <min value="0"/> <max value="*"/> <base> <path value="AdverseEvent.category"/> <min value="0"/> <max value="*"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventCategory"/> </extension> <strength value="extensible"/> <description value="Overall categorization of the event, e.g. product-related or situational."/> <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-category"/> </binding> <mapping> <identity value="w5"/> <map value="FiveWs.class"/> </mapping> </element> <element id="AdverseEvent.event"> <path value="AdverseEvent.event"/> <short value="Event or incident that occurred or was averted (イベント)"/> <definition value="Specific event that occurred or that was averted, such as patient fall, wrong organ removed, or wrong blood transfused. (患者の転倒、誤った臓器の摘出、誤った輸血など、発生した、または回避された特定の出来事。)"/> <min value="1"/> <max value="1"/> <base> <path value="AdverseEvent.event"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <binding> <strength value="example"/> <valueSet value="http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-type-vs"/> </binding> <mapping> <identity value="w5"/> <map value="FiveWs.what[x]"/> </mapping> </element> <element id="AdverseEvent.event.id"> <path value="AdverseEvent.event.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="0"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="AdverseEvent.event.extension"> <path value="AdverseEvent.event.extension"/> <slicing> <discriminator> <type value="value"/> <path value="url"/> </discriminator> <description value="Extensions are always sliced by (at least) url"/> <rules value="open"/> </slicing> <short value="Extension"/> <definition value="An Extension"/> <min value="0"/> <max value="0"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="AdverseEvent.event.coding"> <path value="AdverseEvent.event.coding"/> <slicing> <discriminator> <type value="value"/> <path value="system"/> </discriminator> <rules value="open"/> </slicing> <short value="Code defined by a terminology system (イベントのコード)"/> <definition value="A reference to a code defined by a terminology system."/> <comment value="Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true."/> <requirements value="Allows for alternative encodings within a code system, and translations to other code systems."/> <alias value="コード"/> <alias value="Coding"/> <min value="0"/> <max value="*"/> <base> <path value="CodeableConcept.coding"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Coding"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="C*E.1-8, C*E.10-22"/> </mapping> <mapping> <identity value="rim"/> <map value="union(., ./translation)"/> </mapping> <mapping> <identity value="orim"/> <map value="fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"/> </mapping> </element> <element id="AdverseEvent.event.coding:snomed"> <path value="AdverseEvent.event.coding"/> <sliceName value="snomed"/> <short value="Code defined by a terminology system (イベントを表すコード)"/> <definition value="A reference to a code defined by a terminology system."/> <comment value="Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true."/> <requirements value="Allows for alternative encodings within a code system, and translations to other code systems."/> <min value="0"/> <max value="1"/> <base> <path value="CodeableConcept.coding"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Coding"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <binding> <strength value="required"/> <valueSet value="http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-type-vs"/> </binding> <mapping> <identity value="v2"/> <map value="C*E.1-8, C*E.10-22"/> </mapping> <mapping> <identity value="rim"/> <map value="union(., ./translation)"/> </mapping> <mapping> <identity value="orim"/> <map value="fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding"/> </mapping> </element> <element id="AdverseEvent.event.coding:snomed.id"> <path value="AdverseEvent.event.coding.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="0"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="AdverseEvent.event.coding:snomed.extension"> <path value="AdverseEvent.event.coding.extension"/> <slicing> <discriminator> <type value="value"/> <path value="url"/> </discriminator> <description value="Extensions are always sliced by (at least) url"/> <rules value="open"/> </slicing> <short value="Extension"/> <definition value="An Extension"/> <min value="0"/> <max value="0"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> </element> <element id="AdverseEvent.event.coding:snomed.system"> <path value="AdverseEvent.event.coding.system"/> <short value="Identity of the terminology system (イベントを定義するコード体系)"/> <definition value="The identification of the code system that defines the meaning of the symbol in the code."/> <comment value="The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should reference to some definition that establishes the system clearly and unambiguously."/> <requirements value="Need to be unambiguous about the source of the definition of the symbol."/> <alias value="コードシステム"/> <alias value="System"/> <min value="1"/> <max value="1"/> <base> <path value="Coding.system"/> <min value="0"/> <max value="1"/> </base> <type> <code value="uri"/> </type> <fixedUri value="http://snomed.info/sct"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="C*E.3"/> </mapping> <mapping> <identity value="rim"/> <map value="./codeSystem"/> </mapping> <mapping> <identity value="orim"/> <map value="fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem"/> </mapping> </element> <element id="AdverseEvent.event.coding:snomed.version"> <path value="AdverseEvent.event.coding.version"/> <short value="Version of the system - if relevant"/> <definition value="The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged."/> <comment value="Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date."/> <min value="0"/> <max value="0"/> <base> <path value="Coding.version"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="C*E.7"/> </mapping> <mapping> <identity value="rim"/> <map value="./codeSystemVersion"/> </mapping> <mapping> <identity value="orim"/> <map value="fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion"/> </mapping> </element> <element id="AdverseEvent.event.coding:snomed.code"> <path value="AdverseEvent.event.coding.code"/> <short value="Symbol in syntax defined by the system (イベントを表すコード値)"/> <definition value="A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination)."/> <requirements value="Need to refer to a particular code in the system."/> <alias value="コード"/> <alias value="Code"/> <min value="1"/> <max value="1"/> <base> <path value="Coding.code"/> <min value="0"/> <max value="1"/> </base> <type> <code value="code"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="C*E.1"/> </mapping> <mapping> <identity value="rim"/> <map value="./code"/> </mapping> <mapping> <identity value="orim"/> <map value="fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code"/> </mapping> </element> <element id="AdverseEvent.event.coding:snomed.display"> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable"> <valueBoolean value="true"/> </extension> <path value="AdverseEvent.event.coding.display"/> <short value="Representation defined by the system (イベントの表示名)"/> <definition value="A representation of the meaning of the code in the system, following the rules of the system."/> <requirements value="Need to be able to carry a human-readable meaning of the code for readers that do not know the system."/> <alias value="表示名"/> <alias value="Display"/> <min value="1"/> <max value="1"/> <base> <path value="Coding.display"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="C*E.2 - but note this is not well followed"/> </mapping> <mapping> <identity value="rim"/> <map value="CV.displayName"/> </mapping> <mapping> <identity value="orim"/> <map value="fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName"/> </mapping> </element> <element id="AdverseEvent.event.coding:snomed.userSelected"> <path value="AdverseEvent.event.coding.userSelected"/> <short value="If this coding was chosen directly by the user"/> <definition value="Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays)."/> <comment value="Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely."/> <requirements value="This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing."/> <min value="0"/> <max value="0"/> <base> <path value="Coding.userSelected"/> <min value="0"/> <max value="1"/> </base> <type> <code value="boolean"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="Sometimes implied by being first"/> </mapping> <mapping> <identity value="rim"/> <map value="CD.codingRationale"/> </mapping> <mapping> <identity value="orim"/> <map value="fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]"/> </mapping> </element> <element id="AdverseEvent.event.text"> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable"> <valueBoolean value="true"/> </extension> <path value="AdverseEvent.event.text"/> <short value="Plain text representation of the concept (イベント)"/> <definition value="A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user."/> <comment value="Very often the text is the same as a displayName of one of the codings."/> <requirements value="The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source."/> <alias value="テキスト"/> <alias value="Text"/> <min value="0"/> <max value="1"/> <base> <path value="CodeableConcept.text"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="C*E.9. But note many systems use C*E.2 for this"/> </mapping> <mapping> <identity value="rim"/> <map value="./originalText[mediaType/code="text/plain"]/data"/> </mapping> <mapping> <identity value="orim"/> <map value="fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText"/> </mapping> </element> <element id="AdverseEvent.subject"> <path value="AdverseEvent.subject"/> <short value="Subject impacted by event (患者)"/> <definition value="This subject or group impacted by the event."/> <comment value="If AdverseEvent.resultingCondition differs among members of the group, then use Patient as the subject."/> <requirements value="Allows for exposure of biohazard (such as legionella) to a group of individuals in a hospital."/> <alias value="patient"/> <min value="1"/> <max value="1"/> <base> <path value="AdverseEvent.subject"/> <min value="1"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-patient"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Group"/> <targetProfile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-practitioner"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/RelatedPerson"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="w5"/> <map value="FiveWs.who"/> </mapping> </element> <element id="AdverseEvent.encounter"> <path value="AdverseEvent.encounter"/> <short value="Encounter created as part of (関連する外来または入院)"/> <definition value="The Encounter during which AdverseEvent was created or to which the creation of this record is tightly associated."/> <comment value="This will typically be the encounter the event occurred within, but some activities may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter. For example, if a medication administration was considered an adverse event because it resulted in a rash, then the encounter when the medication administration was given is the context. If the patient reports the AdverseEvent during a second encounter, that second encounter is not the context."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.encounter"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-encounter"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="w5"/> <map value="FiveWs.context"/> </mapping> </element> <element id="AdverseEvent.date"> <path value="AdverseEvent.date"/> <short value="When the event occurred (発生日)"/> <definition value="The date (and perhaps time) when the adverse event occurred."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.date"/> <min value="0"/> <max value="1"/> </base> <type> <code value="dateTime"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="w5"/> <map value="FiveWs.init"/> </mapping> </element> <element id="AdverseEvent.detected"> <path value="AdverseEvent.detected"/> <short value="When the event was detected (検出日)"/> <definition value="Estimated or actual date the AdverseEvent began, in the opinion of the reporter."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.detected"/> <min value="0"/> <max value="1"/> </base> <type> <code value="dateTime"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.recordedDate"> <path value="AdverseEvent.recordedDate"/> <short value="When the event was recorded (記録日)"/> <definition value="The date on which the existence of the AdverseEvent was first recorded."/> <comment value="The recordedDate represents the date when this particular AdverseEvent record was created in the system, not the date of the most recent update. The date of the last record modification can be retrieved from the resource metadata."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.recordedDate"/> <min value="0"/> <max value="1"/> </base> <type> <code value="dateTime"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="w5"/> <map value="FiveWs.recorded"/> </mapping> </element> <element id="AdverseEvent.resultingCondition"> <path value="AdverseEvent.resultingCondition"/> <short value="Effect on the subject due to this event"/> <definition value="Includes information about the reaction that occurred as a result of exposure to a substance (for example, a drug or a chemical)."/> <min value="0"/> <max value="0"/> <base> <path value="AdverseEvent.resultingCondition"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Condition"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.location"> <path value="AdverseEvent.location"/> <short value="Location where adverse event occurred (発生場所)"/> <definition value="The information about where the adverse event occurred."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.location"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Location"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.seriousness"> <path value="AdverseEvent.seriousness"/> <short value="Investigator defined severity of the adverse event, in relation to the subject not the resulting condition (重篤度)"/> <definition value="Assessment whether this event was of real importance."/> <min value="1"/> <max value="1"/> <base> <path value="AdverseEvent.seriousness"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <binding> <strength value="required"/> <valueSet value="http://terminology.hl7.org/ValueSet/adverse-event-seriousness"/> </binding> </element> <element id="AdverseEvent.severity"> <path value="AdverseEvent.severity"/> <short value="mild | moderate | severe (深刻度)"/> <definition value="Describes the severity of the adverse event, in relation to the subject. Contrast to AdverseEvent.seriousness - a severe rash might not be serious, but a mild heart problem is."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.severity"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventSeverity"/> </extension> <strength value="required"/> <description value="The severity of the adverse event itself, in direct relation to the subject."/> <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-severity|4.0.1"/> </binding> </element> <element id="AdverseEvent.outcome"> <path value="AdverseEvent.outcome"/> <short value="resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown (アウトカム)"/> <definition value="Describes the type of outcome from the adverse event."/> <min value="1"/> <max value="1"/> <base> <path value="AdverseEvent.outcome"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <binding> <strength value="required"/> <valueSet value="http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes"/> </binding> </element> <element id="AdverseEvent.recorder"> <path value="AdverseEvent.recorder"/> <short value="Who recorded the adverse event (記録者)"/> <definition value="Information on who recorded the adverse event. May be the patient or a practitioner."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.recorder"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-patient"/> <targetProfile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-practitioner"/> <targetProfile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-practitionerrole"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/RelatedPerson"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="w5"/> <map value="FiveWs.author"/> </mapping> </element> <element id="AdverseEvent.contributor"> <path value="AdverseEvent.contributor"/> <short value="Who was involved in the adverse event or the potential adverse event (関与した人)"/> <definition value="Parties that may or should contribute or have contributed information to the adverse event, which can consist of one or more activities. Such information includes information leading to the decision to perform the activity and how to perform the activity (e.g. consultant), information that the activity itself seeks to reveal (e.g. informant of clinical history), or information about what activity was performed (e.g. informant witness)."/> <min value="0"/> <max value="*"/> <base> <path value="AdverseEvent.contributor"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Practitioner"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Device"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.suspectEntity"> <path value="AdverseEvent.suspectEntity"/> <short value="The suspected agent causing the adverse event"/> <definition value="Describes the entity that is suspected to have caused the adverse event."/> <min value="0"/> <max value="0"/> <base> <path value="AdverseEvent.suspectEntity"/> <min value="0"/> <max value="*"/> </base> <type> <code value="BackboneElement"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.suspectEntity.id"> <path value="AdverseEvent.suspectEntity.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="AdverseEvent.suspectEntity.extension"> <path value="AdverseEvent.suspectEntity.extension"/> <short value="Additional content defined by implementations"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="AdverseEvent.suspectEntity.modifierExtension"> <path value="AdverseEvent.suspectEntity.modifierExtension"/> <short value="Extensions that cannot be ignored even if unrecognized"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/> <alias value="extensions"/> <alias value="user content"/> <alias value="modifiers"/> <min value="0"/> <max value="*"/> <base> <path value="BackboneElement.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="AdverseEvent.suspectEntity.instance"> <path value="AdverseEvent.suspectEntity.instance"/> <short value="Refers to the specific entity that caused the adverse event"/> <definition value="Identifies the actual instance of what caused the adverse event. May be a substance, medication, medication administration, medication statement or a device."/> <alias value="Substance or Medication or Device"/> <min value="1"/> <max value="1"/> <base> <path value="AdverseEvent.suspectEntity.instance"/> <min value="1"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Immunization"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Procedure"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Substance"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Medication"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicationAdministration"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/MedicationStatement"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Device"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.suspectEntity.causality"> <path value="AdverseEvent.suspectEntity.causality"/> <short value="Information on the possible cause of the event"/> <definition value="Information on the possible cause of the event."/> <min value="0"/> <max value="*"/> <base> <path value="AdverseEvent.suspectEntity.causality"/> <min value="0"/> <max value="*"/> </base> <type> <code value="BackboneElement"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.suspectEntity.causality.id"> <path value="AdverseEvent.suspectEntity.causality.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="AdverseEvent.suspectEntity.causality.extension"> <path value="AdverseEvent.suspectEntity.causality.extension"/> <short value="Additional content defined by implementations"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="AdverseEvent.suspectEntity.causality.modifierExtension"> <path value="AdverseEvent.suspectEntity.causality.modifierExtension"/> <short value="Extensions that cannot be ignored even if unrecognized"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/> <comment value="There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone."/> <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R4/extensibility.html#modifierExtension)."/> <alias value="extensions"/> <alias value="user content"/> <alias value="modifiers"/> <min value="0"/> <max value="*"/> <base> <path value="BackboneElement.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <xpath value="exists(f:extension)!=exists(f:*[starts-with(local-name(.), "value")])"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="AdverseEvent.suspectEntity.causality.assessment"> <path value="AdverseEvent.suspectEntity.causality.assessment"/> <short value="Assessment of if the entity caused the event"/> <definition value="Assessment of if the entity caused the event."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.suspectEntity.causality.assessment"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventCausalityAssessment"/> </extension> <strength value="example"/> <description value="Codes for the assessment of whether the entity caused the event."/> <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-causality-assess"/> </binding> </element> <element id="AdverseEvent.suspectEntity.causality.productRelatedness"> <path value="AdverseEvent.suspectEntity.causality.productRelatedness"/> <short value="AdverseEvent.suspectEntity.causalityProductRelatedness"/> <definition value="AdverseEvent.suspectEntity.causalityProductRelatedness."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.suspectEntity.causality.productRelatedness"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.suspectEntity.causality.author"> <path value="AdverseEvent.suspectEntity.causality.author"/> <short value="AdverseEvent.suspectEntity.causalityAuthor"/> <definition value="AdverseEvent.suspectEntity.causalityAuthor."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.suspectEntity.causality.author"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Practitioner"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/PractitionerRole"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.suspectEntity.causality.method"> <path value="AdverseEvent.suspectEntity.causality.method"/> <short value="ProbabilityScale | Bayesian | Checklist"/> <definition value="ProbabilityScale | Bayesian | Checklist."/> <min value="0"/> <max value="1"/> <base> <path value="AdverseEvent.suspectEntity.causality.method"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="AdverseEventCausalityMethod"/> </extension> <strength value="example"/> <description value="TODO."/> <valueSet value="http://hl7.org/fhir/ValueSet/adverse-event-causality-method"/> </binding> </element> <element id="AdverseEvent.subjectMedicalHistory"> <path value="AdverseEvent.subjectMedicalHistory"/> <short value="AdverseEvent.subjectMedicalHistory"/> <definition value="AdverseEvent.subjectMedicalHistory."/> <min value="0"/> <max value="0"/> <base> <path value="AdverseEvent.subjectMedicalHistory"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Condition"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Observation"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/AllergyIntolerance"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/FamilyMemberHistory"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Immunization"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Procedure"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Media"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.referenceDocument"> <path value="AdverseEvent.referenceDocument"/> <short value="AdverseEvent.referenceDocument"/> <definition value="AdverseEvent.referenceDocument."/> <min value="0"/> <max value="0"/> <base> <path value="AdverseEvent.referenceDocument"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="AdverseEvent.study"> <path value="AdverseEvent.study"/> <short value="AdverseEvent.study (臨床研究の参照)"/> <definition value="AdverseEvent.study."/> <min value="1"/> <max value="1"/> <base> <path value="AdverseEvent.study"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ResearchStudy"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <xpath value="@value|f:*|h:div"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> </snapshot> <differential> <element id="AdverseEvent"> <path value="AdverseEvent"/> <short value="Fujitsu Adverse Event Clinical Research (臨床研究有害事象プロファイル)"/> <definition value="This profile defines the patient's adverse event clinical research. "/> </element> <element id="AdverseEvent.id"> <path value="AdverseEvent.id"/> <short value="Logical id of this artifact (自動採番される論理ID)"/> </element> <element id="AdverseEvent.meta"> <path value="AdverseEvent.meta"/> <short value="Metadata about the resource (リソースのメタデータ)"/> </element> <element id="AdverseEvent.implicitRules"> <path value="AdverseEvent.implicitRules"/> <max value="0"/> </element> <element id="AdverseEvent.language"> <path value="AdverseEvent.language"/> <max value="0"/> </element> <element id="AdverseEvent.text"> <path value="AdverseEvent.text"/> <short value="Text summary of the resource, for human interpretation (リソースの概要)"/> </element> <element id="AdverseEvent.contained"> <path value="AdverseEvent.contained"/> <short value="Contained, inline Resources (リソース内リソース)"/> </element> <element id="AdverseEvent.extension"> <path value="AdverseEvent.extension"/> <slicing> <discriminator> <type value="value"/> <path value="url"/> </discriminator> <ordered value="false"/> <rules value="open"/> </slicing> <short value="Additional content defined by implementations (要素の拡張)"/> </element> <element id="AdverseEvent.extension:research-subject-ref"> <path value="AdverseEvent.extension"/> <sliceName value="research-subject-ref"/> <short value="Research Subject record of subject (被験者の研究対象記録)"/> <min value="0"/> <max value="1"/> <type> <code value="Extension"/> <profile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-research-subject-ref"/> </type> </element> <element id="AdverseEvent.extension:caused-subject-to-discontinue-study"> <path value="AdverseEvent.extension"/> <sliceName value="caused-subject-to-discontinue-study"/> <min value="0"/> <max value="1"/> <type> <code value="Extension"/> <profile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-caused-subject-to-discontinue-study"/> </type> </element> <element id="AdverseEvent.extension:seriousness-criteria"> <path value="AdverseEvent.extension"/> <sliceName value="seriousness-criteria"/> <short value="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)"/> <min value="0"/> <max value="*"/> <type> <code value="Extension"/> <profile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-seriousness-criteria"/> </type> </element> <element id="AdverseEvent.extension:ae-grade"> <path value="AdverseEvent.extension"/> <sliceName value="ae-grade"/> <short value="The degree of something undesirable, used in oncology trial (グレード)"/> <min value="0"/> <max value="1"/> <type> <code value="Extension"/> <profile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-ae-grade"/> </type> </element> <element id="AdverseEvent.extension:expected-in-research-study"> <path value="AdverseEvent.extension"/> <sliceName value="expected-in-research-study"/> <short value="Considered likely or probable or anticipated in the research study (予想された結果かどうか)"/> <min value="0"/> <max value="1"/> <type> <code value="Extension"/> <profile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-expected-in-research-study"/> </type> </element> <element id="AdverseEvent.extension:note"> <path value="AdverseEvent.extension"/> <sliceName value="note"/> <short value="Comment on adverse event (有害事象のコメント)"/> <min value="0"/> <max value="*"/> <type> <code value="Extension"/> <profile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-note"/> </type> </element> <element id="AdverseEvent.extension:resolve-date"> <path value="AdverseEvent.extension"/> <sliceName value="resolve-date"/> <short value="Adverse Event resolution date (解決日)"/> <min value="0"/> <max value="1"/> <type> <code value="Extension"/> <profile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-resolve-date"/> </type> </element> <element id="AdverseEvent.extension:suspect-entity"> <path value="AdverseEvent.extension"/> <sliceName value="suspect-entity"/> <short value="A suspected agent causing the adverse event (原因と疑われる薬剤)"/> <definition value="Describes an entity that is suspected to have caused the adverse event. (有害事象を引き起こしたと疑われる因子を記述する。)"/> <min value="0"/> <max value="*"/> <type> <code value="Extension"/> <profile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-suspect-entity"/> </type> <isSummary value="true"/> </element> <element id="AdverseEvent.extension:contributing-factor"> <path value="AdverseEvent.extension"/> <sliceName value="contributing-factor"/> <short value="Contributing factors suspected to have increased the probability or severity of the adverse event (寄与要因)"/> <definition value="A contributing factors suspected to have increased the probability or severity of the adverse event. (有害事象の発生確率または重症度を高めたと疑われる要因)"/> <min value="0"/> <max value="*"/> <type> <code value="Extension"/> <profile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-contributing-factor"/> </type> <isSummary value="true"/> </element> <element id="AdverseEvent.extension:mitigating-action"> <path value="AdverseEvent.extension"/> <sliceName value="mitigating-action"/> <short value="Ameliorating actions taken after the adverse event occurred in order to reduce the extent of harm (改善措置)"/> <definition value="The ameliorating action taken after the adverse event occurred in order to reduce the extent of harm. (有害事象の発生後、被害の程度を軽減するために取られた改善措置)"/> <min value="0"/> <max value="*"/> <type> <code value="Extension"/> <profile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-mitigating-action"/> </type> <isSummary value="true"/> </element> <element id="AdverseEvent.extension:supporting-info"> <path value="AdverseEvent.extension"/> <sliceName value="supporting-info"/> <short value="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)"/> <min value="0"/> <max value="*"/> <type> <code value="Extension"/> <profile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-supporting-info"/> </type> <isSummary value="true"/> </element> <element id="AdverseEvent.extension:participant"> <path value="AdverseEvent.extension"/> <sliceName value="participant"/> <short value="Who was involved in the adverse event or the potential adverse event and what they did (関係者)"/> <min value="0"/> <max value="*"/> <type> <code value="Extension"/> <profile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-participant"/> </type> </element> <element id="AdverseEvent.extension:resultingEffect"> <path value="AdverseEvent.extension"/> <sliceName value="resultingEffect"/> <short value="Effect on the subject due to this event (被験者への影響)"/> <min value="0"/> <max value="*"/> <type> <code value="Extension"/> <profile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-resulting-effect"/> </type> </element> <element id="AdverseEvent.modifierExtension"> <path value="AdverseEvent.modifierExtension"/> <slicing> <discriminator> <type value="value"/> <path value="url"/> </discriminator> <ordered value="false"/> <rules value="open"/> </slicing> <short value="Extensions that cannot be ignored (無視できない拡張)"/> <min value="1"/> </element> <element id="AdverseEvent.modifierExtension:status"> <path value="AdverseEvent.modifierExtension"/> <sliceName value="status"/> <short value="in-progress | completed | entered-in-error | unknown (ワークフローの状態)"/> <definition value="The current state of the adverse event or potential adverse event. (いかなる規制または品質機関への事象の報告でもない。 これは患者の状態の結果ではない。)"/> <comment value="This is not the reporting of the event to any regulatory or quality organization. This is not the outcome of the patient's condition."/> <min value="1"/> <max value="1"/> <type> <code value="Extension"/> <profile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-extension-status"/> </type> <isModifierReason value="This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid"/> <isSummary value="true"/> </element> <element id="AdverseEvent.identifier"> <path value="AdverseEvent.identifier"/> <short value="Business Identifier for observation (識別子)"/> </element> <element id="AdverseEvent.actuality"> <path value="AdverseEvent.actuality"/> <short value="actual (有害事象の全体的な性質)"/> <patternCode value="actual"/> </element> <element id="AdverseEvent.category"> <path value="AdverseEvent.category"/> <short value="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)"/> </element> <element id="AdverseEvent.event"> <path value="AdverseEvent.event"/> <short value="Event or incident that occurred or was averted (イベント)"/> <definition value="Specific event that occurred or that was averted, such as patient fall, wrong organ removed, or wrong blood transfused. (患者の転倒、誤った臓器の摘出、誤った輸血など、発生した、または回避された特定の出来事。)"/> <min value="1"/> <binding> <strength value="example"/> <valueSet value="http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-type-vs"/> </binding> </element> <element id="AdverseEvent.event.id"> <path value="AdverseEvent.event.id"/> <max value="0"/> </element> <element id="AdverseEvent.event.extension"> <path value="AdverseEvent.event.extension"/> <max value="0"/> </element> <element id="AdverseEvent.event.coding"> <path value="AdverseEvent.event.coding"/> <slicing> <discriminator> <type value="value"/> <path value="system"/> </discriminator> <rules value="open"/> </slicing> <short value="Code defined by a terminology system (イベントのコード)"/> <alias value="コード"/> <alias value="Coding"/> </element> <element id="AdverseEvent.event.coding:snomed"> <path value="AdverseEvent.event.coding"/> <sliceName value="snomed"/> <short value="Code defined by a terminology system (イベントを表すコード)"/> <min value="0"/> <max value="1"/> <binding> <strength value="required"/> <valueSet value="http://hl7.org/fhir/uv/ae-research-backport-ig/ValueSet/adverse-event-type-vs"/> </binding> </element> <element id="AdverseEvent.event.coding:snomed.id"> <path value="AdverseEvent.event.coding.id"/> <max value="0"/> </element> <element id="AdverseEvent.event.coding:snomed.extension"> <path value="AdverseEvent.event.coding.extension"/> <max value="0"/> </element> <element id="AdverseEvent.event.coding:snomed.system"> <path value="AdverseEvent.event.coding.system"/> <short value="Identity of the terminology system (イベントを定義するコード体系)"/> <alias value="コードシステム"/> <alias value="System"/> <min value="1"/> <fixedUri value="http://snomed.info/sct"/> </element> <element id="AdverseEvent.event.coding:snomed.version"> <path value="AdverseEvent.event.coding.version"/> <max value="0"/> </element> <element id="AdverseEvent.event.coding:snomed.code"> <path value="AdverseEvent.event.coding.code"/> <short value="Symbol in syntax defined by the system (イベントを表すコード値)"/> <alias value="コード"/> <alias value="Code"/> <min value="1"/> </element> <element id="AdverseEvent.event.coding:snomed.display"> <path value="AdverseEvent.event.coding.display"/> <short value="Representation defined by the system (イベントの表示名)"/> <alias value="表示名"/> <alias value="Display"/> <min value="1"/> </element> <element id="AdverseEvent.event.coding:snomed.userSelected"> <path value="AdverseEvent.event.coding.userSelected"/> <max value="0"/> </element> <element id="AdverseEvent.event.text"> <path value="AdverseEvent.event.text"/> <short value="Plain text representation of the concept (イベント)"/> <alias value="テキスト"/> <alias value="Text"/> </element> <element id="AdverseEvent.subject"> <path value="AdverseEvent.subject"/> <short value="Subject impacted by event (患者)"/> <type> <code value="Reference"/> <targetProfile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-patient"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Group"/> <targetProfile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-practitioner"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/RelatedPerson"/> </type> </element> <element id="AdverseEvent.encounter"> <path value="AdverseEvent.encounter"/> <short value="Encounter created as part of (関連する外来または入院)"/> <type> <code value="Reference"/> <targetProfile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-encounter"/> </type> </element> <element id="AdverseEvent.date"> <path value="AdverseEvent.date"/> <short value="When the event occurred (発生日)"/> </element> <element id="AdverseEvent.detected"> <path value="AdverseEvent.detected"/> <short value="When the event was detected (検出日)"/> </element> <element id="AdverseEvent.recordedDate"> <path value="AdverseEvent.recordedDate"/> <short value="When the event was recorded (記録日)"/> </element> <element id="AdverseEvent.resultingCondition"> <path value="AdverseEvent.resultingCondition"/> <max value="0"/> </element> <element id="AdverseEvent.location"> <path value="AdverseEvent.location"/> <short value="Location where adverse event occurred (発生場所)"/> </element> <element id="AdverseEvent.seriousness"> <path value="AdverseEvent.seriousness"/> <short value="Investigator defined severity of the adverse event, in relation to the subject not the resulting condition (重篤度)"/> <min value="1"/> <binding> <strength value="required"/> <valueSet value="http://terminology.hl7.org/ValueSet/adverse-event-seriousness"/> </binding> </element> <element id="AdverseEvent.severity"> <path value="AdverseEvent.severity"/> <short value="mild | moderate | severe (深刻度)"/> </element> <element id="AdverseEvent.outcome"> <path value="AdverseEvent.outcome"/> <short value="resolved | recovering | ongoing | resolvedWithSequelae | fatal | unknown (アウトカム)"/> <min value="1"/> <binding> <strength value="required"/> <valueSet value="http://terminology.hl7.org/ValueSet/adverse-event-clinical-research-outcomes"/> </binding> </element> <element id="AdverseEvent.recorder"> <path value="AdverseEvent.recorder"/> <short value="Who recorded the adverse event (記録者)"/> <type> <code value="Reference"/> <targetProfile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-patient"/> <targetProfile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-practitioner"/> <targetProfile value="http://ig.fujitsu.com/healthy-living/StructureDefinition/fujitsu-practitionerrole"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/RelatedPerson"/> </type> </element> <element id="AdverseEvent.contributor"> <path value="AdverseEvent.contributor"/> <short value="Who was involved in the adverse event or the potential adverse event (関与した人)"/> </element> <element id="AdverseEvent.suspectEntity"> <path value="AdverseEvent.suspectEntity"/> <max value="0"/> </element> <element id="AdverseEvent.subjectMedicalHistory"> <path value="AdverseEvent.subjectMedicalHistory"/> <max value="0"/> </element> <element id="AdverseEvent.referenceDocument"> <path value="AdverseEvent.referenceDocument"/> <max value="0"/> </element> <element id="AdverseEvent.study"> <path value="AdverseEvent.study"/> <short value="AdverseEvent.study (臨床研究の参照)"/> <min value="1"/> <max value="1"/> </element> </differential> </StructureDefinition>