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

: ClinicalResearchAdverseEventUseCase15 - 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 xsd: <http://www.w3.org/2001/XMLSchema#> .

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

 a fhir:_AdverseEvent ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "ClinicalResearchAdverseEventUseCase15"] ; # 
  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=\"ClinicalResearchAdverseEventUseCase15\"> </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;ClinicalResearchAdverseEventUseCase15&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-AdverseEvent-clinical-research.html\">Adverse Event Clinical Research</a></p></div><p><b>Severity Or Grade</b>: Severe <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>#3)</span></p><p><b>Resulting Effect</b>: <a href=\"Condition-GIBleedUseCase15.html\">Condition/GIBleedUseCase15</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-study-medication-administration-ABC.html\">MedicationAdministration/study-medication-administration-ABC</a></p><blockquote><p><b>url</b></p><code>causality</code></blockquote></blockquote><p><b>Adverse Event resolution date</b>: 2021-12-09</p><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>: resultsInPersistentOrSignificantDisability <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>: requiresInpatientHospitalization <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>: resultsInDeath <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>: isLifeThreatening <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>: congenitalAnomalyBirthDefect <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>: otherMedicallyImportantCondition <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><blockquote><p><b>Mitigating Action</b></p><blockquote><p><b>url</b></p><code>item</code></blockquote><p><b>value</b>: <a href=\"Procedure-procedure-upper-endoscopy.html\">Procedure/procedure-upper-endoscopy</a></p></blockquote><blockquote><p><b>Mitigating Action</b></p><blockquote><p><b>url</b></p><code>item</code></blockquote><p><b>value</b>: study drug withdrawn <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>#C49502 &quot;DRUG WITHDRAWN&quot;)</span></p></blockquote><blockquote><p><b>Mitigating Action</b></p><blockquote><p><b>url</b></p><code>item</code></blockquote><p><b>value</b>: <a href=\"MedicationRequest-medicationrequest-for-study-medication-administration-ABC.html\">MedicationRequest/medicationrequest-for-study-medication-administration-ABC: Medication Request where study drug prescription was discontinued</a></p></blockquote><p><b>Adverse event caused subject to discontinue the study</b>: true</p><p><b>Expected In Research Study</b>: false</p><blockquote><p><b>Supporting information relevant to the event</b></p><blockquote><p><b>url</b></p><code>item</code></blockquote><p><b>value</b>: <span>: Supporting info would have context such as an Observation on the drop in hemoglobin</span></p></blockquote><p><b>Note</b>: The patient’s hemoglobin dropped to 6.5 g/dL and received 2 units of PRBCs. The patient had an upper endoscopy that showed a moderate amount of bleeding from the esophagus. The site was cauterized, and the patient had no further bleeding after the procedure. The GI bleed resolved within one week after discontinuation of study drug and the patient was discharged on 9-Dec-2021 in good condition.</p><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>: Gastrointestinal haemorrhage <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (www.meddra.org#10017955)</span></p><p><b>subject</b>: <a href=\"Patient-SCHJO.html\">Patient/SCHJO</a> &quot;&quot;</p><p><b>date</b>: 2021-12-02</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>: C49498&quot;Recovered/Resolved&quot; <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>#C49498&quot;Recovered/Resolved&quot;)</span></p><p><b>study</b>: <a href=\"ResearchStudy-research-study-XYZ.html\">ResearchStudy/research-study-XYZ</a></p></div>"
  ] ; # 
  fhir:extension ( [
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 "3" ] ;
fhir:display [ fhir:v "Severe" ]       ] )     ]
  ] [
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/GIBleedUseCase15" ]     ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "instance"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "MedicationAdministration/study-medication-administration-ABC" ]       ]     ] [
      ( fhir:extension [
fhir:url [ fhir:v "entityRelatedness"^^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 "C53258" ] ;
fhir:display [ fhir:v "Possibly Related" ]           ] )         ]       ] ) ;
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:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resolve-date"^^xsd:anyURI ] ;
fhir:value [ fhir:v "2021-12-09"^^xsd:date ]
  ] [
    ( 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 "resultsInPersistentOrSignificantDisability" ]         ] )       ]     ] [
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 "requiresInpatientHospitalization" ]         ] )       ]     ] [
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 "resultsInDeath" ]         ] )       ]     ] [
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 "isLifeThreatening" ]         ] )       ]     ] [
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 "congenitalAnomalyBirthDefect" ]         ] )       ]     ] [
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 "otherMedicallyImportantCondition" ]         ] )       ]     ] [
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:extension [
fhir:url [ fhir:v "item"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "Procedure/procedure-upper-endoscopy" ]       ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action"^^xsd:anyURI ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "item"^^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 "C49502" ] ;
fhir:display [ fhir:v "DRUG WITHDRAWN" ]         ] ) ;
fhir:text [ fhir:v "study drug withdrawn" ]       ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action"^^xsd:anyURI ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "item"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:reference [ fhir:v "MedicationRequest/medicationrequest-for-study-medication-administration-ABC" ] ;
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:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/caused-subject-to-discontinue-study"^^xsd:anyURI ] ;
fhir:value [ fhir:v "true"^^xsd:boolean ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study"^^xsd:anyURI ] ;
fhir:value [ fhir:v "false"^^xsd:boolean ]
  ] [
    ( fhir:extension [
fhir:url [ fhir:v "item"^^xsd:anyURI ] ;
fhir:value [
a fhir:Reference ;
fhir:display [ fhir:v "Supporting info would have context such as an Observation on the drop in hemoglobin" ]       ]     ] ) ;
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info"^^xsd:anyURI ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note"^^xsd:anyURI ] ;
fhir:value [
a fhir:Annotation ;
fhir:text [ fhir:v "The patient’s hemoglobin dropped to 6.5 g/dL and received 2 units of PRBCs. The patient had an upper endoscopy that showed a moderate amount of bleeding from the esophagus. The site was cauterized, and the patient had no further bleeding after the procedure. The GI bleed resolved within one week after discontinuation of study drug and the patient was discharged on 9-Dec-2021 in good condition." ]     ]
  ] ) ; # 
  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 [
fhir:system [ fhir:v "https://www.meddra.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "10017955" ] ;
fhir:display [ fhir:v "Gastrointestinal haemorrhage" ]     ] )
  ] ; # 
  fhir:subject [
fhir:reference [ fhir:v "Patient/SCHJO" ]
  ] ; # 
  fhir:date [ fhir:v "2021-12-02"^^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:display [ 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 "C49498\"Recovered/Resolved\"" ]     ] )
  ] ; # 
  fhir:study ( [
fhir:reference [ fhir:v "ResearchStudy/research-study-XYZ" ]
  ] ) . #