Adverse Event Clinical Research R4 Backport
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This page is part of the Adverse Event Clinical Research R4 Backport (v1.0.0-ballot: STU 1 Ballot 1) based on FHIR R4. . For a full list of available versions, see the Directory of published versions

: ClinicalResearchAdverseEventUseCase7 - TTL Representation

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix sct: <http://snomed.info/id/> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

 a fhir:_AdverseEvent ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "ClinicalResearchAdverseEventUseCase7"] ; # 
  fhir:meta [
    ( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/AdverseEvent-clinical-research"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/AdverseEvent-clinical-research>     ] )
  ] ; # 
  fhir:text [
fhir:status [ fhir:v "extensions" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: AdverseEvent</b><a name=\"ClinicalResearchAdverseEventUseCase7\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource AdverseEvent &quot;ClinicalResearchAdverseEventUseCase7&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-AdverseEvent-clinical-research.html\">Adverse Event Clinical Research</a></p></div><p><b>Resulting Effect</b>: <a href=\"Condition-AEHepaticFailureUseCase7.html\">Condition/AEHepaticFailureUseCase7</a></p><p><b>Resulting Effect</b>: <a href=\"Condition-AEHepaticFailureUseCase7complication.html\">Condition/AEHepaticFailureUseCase7complication</a></p><blockquote><p><b>Suspect Entity</b></p><blockquote><p><b>url</b></p><code>instance</code></blockquote><p><b>value</b>: <a href=\"MedicationAdministration-medadmin0301.html\">MedicationAdministration/medadmin0301: Study Medication Use Case 7</a></p><blockquote><p><b>url</b></p><code>causality</code></blockquote></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Results In Persistent Or Significant Disability <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C11338)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Requires Inpatient Hospitalization <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C83052)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: true</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Results In Death <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C48275)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Is Life Threatening <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C84266)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: true</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Congenital Anomaly or Birth Defect <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C83117)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Other Medically Important Condition <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C82521)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Required Intervention to Prevent Permanent Impairment or Damage (Devices) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-fda-add-seriousness-criteria-cs.html\">FDA Additional Seriousness Criteria CodeSystem</a>#requiresPreventImpairment)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: true</p></blockquote><p><b>Severity Or Grade</b>: Life Threatening or Disabling <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"CodeSystem-adverse-event-severity-or-grade-cs.html\">AdverseEvent Severity or Grade Codes</a>#4)</span></p><blockquote><p><b>Mitigating Action</b></p><blockquote><p><b>url</b></p><code>item</code></blockquote><p><b>value</b>: <a href=\"MedicationRequest-medicationrequest0301-discontinue.html\">MedicationRequest/medicationrequest0301-discontinue: Medication Request where study drug prescription was discontinued</a></p></blockquote><blockquote><p><b>modifierExtension[http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status]</b></p></blockquote><p><b>actuality</b>: actual</p><p><b>event</b>: Serious reportable event associated with product or device <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://browser.ihtsdotools.org/\">SNOMED CT</a>#370901008)</span></p><p><b>subject</b>: <a href=\"Patient-ClinicalTrialSubject5.html\">Patient/ClinicalTrialSubject5</a> &quot; CLINICAL TRAIL&quot;</p><p><b>detected</b>: 1905-08-23</p><p><b>recordedDate</b>: 1905-08-24</p><p><b>seriousness</b>: Serious <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-adverse-event-seriousness.html\">AdverseEventSeriousness</a>#serious)</span></p><p><b>outcome</b>: Recovering/Resolving <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C49496)</span></p><p><b>recorder</b>: <span>: Clinical Research Associate</span></p><p><b>study</b>: <span>: NCT1010101</span></p></div>"
  ] ; # 
  fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "Condition/AEHepaticFailureUseCase7" ]     ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "Condition/AEHepaticFailureUseCase7complication" ]     ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "instance"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "MedicationAdministration/medadmin0301" ] ;
fhir:display [ fhir:v "Study Medication Use Case 7" ]       ]     ] [
      ( fhir:extension [
fhir:url [ fhir:v "entityRelatedness"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
          ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/adverse-event-causality-assess"^^xsd:anyURI ] ;
fhir:code [ fhir:v "certain" ] ;
fhir:display [ fhir:v "Certain" ]           ] )         ]       ] ) ;
fhir:url [ fhir:v "causality"^^xsd:anyURI ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity"^^xsd:anyURI ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "criterionCode"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C11338" ] ;
fhir:display [ fhir:v "Results In Persistent Or Significant Disability" ]         ] )       ]     ] [
fhir:url [ fhir:v "criterionPresent"^^xsd:anyURI ] ;
fhir:value [ fhir:v "false"^^xsd:boolean ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"^^xsd:anyURI ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "criterionCode"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C83052" ] ;
fhir:display [ fhir:v "Requires Inpatient Hospitalization" ]         ] )       ]     ] [
fhir:url [ fhir:v "criterionPresent"^^xsd:anyURI ] ;
fhir:value [ fhir:v "true"^^xsd:boolean ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"^^xsd:anyURI ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "criterionCode"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C48275" ] ;
fhir:display [ fhir:v "Results In Death" ]         ] )       ]     ] [
fhir:url [ fhir:v "criterionPresent"^^xsd:anyURI ] ;
fhir:value [ fhir:v "false"^^xsd:boolean ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"^^xsd:anyURI ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "criterionCode"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C84266" ] ;
fhir:display [ fhir:v "Is Life Threatening" ]         ] )       ]     ] [
fhir:url [ fhir:v "criterionPresent"^^xsd:anyURI ] ;
fhir:value [ fhir:v "true"^^xsd:boolean ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"^^xsd:anyURI ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "criterionCode"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C83117" ] ;
fhir:display [ fhir:v "Congenital Anomaly or Birth Defect" ]         ] )       ]     ] [
fhir:url [ fhir:v "criterionPresent"^^xsd:anyURI ] ;
fhir:value [ fhir:v "false"^^xsd:boolean ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"^^xsd:anyURI ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "criterionCode"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C82521" ] ;
fhir:display [ fhir:v "Other Medically Important Condition" ]         ] )       ]     ] [
fhir:url [ fhir:v "criterionPresent"^^xsd:anyURI ] ;
fhir:value [ fhir:v "false"^^xsd:boolean ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"^^xsd:anyURI ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "criterionCode"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
        ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/CodeSystem/fda-add-seriousness-criteria-cs"^^xsd:anyURI ] ;
fhir:code [ fhir:v "requiresPreventImpairment" ] ;
fhir:display [ fhir:v "Required Intervention to Prevent Permanent Impairment or Damage (Devices)" ]         ] )       ]     ] [
fhir:url [ fhir:v "criterionPresent"^^xsd:anyURI ] ;
fhir:value [ fhir:v "true"^^xsd:boolean ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"^^xsd:anyURI ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/severity-or-grade"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
      ( fhir:coding [
fhir:system [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/CodeSystem/adverse-event-severity-or-grade-cs"^^xsd:anyURI ] ;
fhir:code [ fhir:v "4" ] ;
fhir:display [ fhir:v "Life Threatening or Disabling" ]       ] )     ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "item"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "MedicationRequest/medicationrequest0301-discontinue" ] ;
fhir:display [ fhir:v "Medication Request where study drug prescription was discontinued" ]       ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action"^^xsd:anyURI ]
  ] ) ; # 
  fhir:modifierExtension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status"^^xsd:anyURI ] ;
fhir:value [ fhir:v "completed" ]
  ] ) ; # 
  fhir:actuality [ fhir:v "actual"] ; # 
  fhir:event [
    ( fhir:coding [
a sct:370901008 ;
fhir:system [ fhir:v "http://snomed.info/sct"^^xsd:anyURI ] ;
fhir:code [ fhir:v "370901008" ] ;
fhir:display [ fhir:v "Serious reportable event associated with product or device" ]     ] )
  ] ; # 
  fhir:subject [
fhir:reference [ fhir:v "Patient/ClinicalTrialSubject5" ]
  ] ; # 
  fhir:detected [ fhir:v "1905-08-23"^^xsd:date] ; # 
  fhir:recordedDate [ fhir:v "1905-08-24"^^xsd:date] ; # 
  fhir:seriousness [
    ( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"^^xsd:anyURI ] ;
fhir:code [ fhir:v "serious" ]     ] )
  ] ; # 
  fhir:outcome [
    ( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C49496" ] ;
fhir:display [ fhir:v "Recovering/Resolving" ]     ] )
  ] ; # 
  fhir:recorder [
fhir:display [ fhir:v "Clinical Research Associate" ]
  ] ; # 
  fhir:study ( [
fhir:display [ fhir:v "NCT1010101" ]
  ] ) . #