Adverse Event Clinical Research
1.0.1 - STU1

Adverse Event Clinical Research, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-ae-research-ig/ and changes regularly. See the Directory of published versions

## : ClinicalTrialSignificantAdverseEvent - TTL Representation

Page standards status: Informative

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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 "ClinicalTrialSignificantAdverseEvent"] ; #
      fhir:meta [
        ( fhir:profile [
    fhir:v "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/AdverseEvent-clinical-research"^^xsd:anyURI ;
    fhir:link <http://hl7.org/fhir/uv/ae-research-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=\"ClinicalTrialSignificantAdverseEvent\"> </a><a name=\"hcClinicalTrialSignificantAdverseEvent\"> </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;ClinicalTrialSignificantAdverseEvent&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-AdverseEvent-clinical-research.html\">Adverse Event Clinical Research</a></p></div><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/5.5.0/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/5.5.0/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>: Death Related to Adverse Event <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/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/5.5.0/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/5.5.0/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/5.5.0/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/damage <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C201939)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: true</p></blockquote><p><b>Adverse Event Severity</b>: Severe <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-adverse-event-severity.html\">AdverseEventSeverity</a>#severe)</span></p><p><b>status</b>: completed</p><p><b>actuality</b>: actual</p><p><b>code</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 TRIAL&quot;</p><p><b>detected</b>: 1905-08-23</p><p><b>recordedDate</b>: 1905-08-24</p><p><b>resultingEffect</b>: </p><ul><li><a href=\"Condition-AEHepaticFailure.html\">Condition/AEHepaticFailure</a></li><li><a href=\"Condition-AEHepaticFailurecomplication.html\">Condition/AEHepaticFailurecomplication</a></li></ul><p><b>seriousness</b>: Serious <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/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/5.5.0/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><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href=\"MedicationAdministration-medadmin0301.html\">MedicationAdministration/medadmin0301: Study Medication</a></p><h3>Causalities</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>EntityRelatedness</b></td></tr><tr><td style=\"display: none\">*</td><td>Related <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C53260)</span></td></tr></table></blockquote><h3>MitigatingActions</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Item[x]</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"MedicationRequest-medicationrequest0301-discontinue.html\">MedicationRequest/medicationrequest0301-discontinue: Medication Request where study drug prescription was discontinued</a></td></tr></table></div>"
      ] ; #
      fhir:extension ( [
        ( 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-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-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 "Death Related to Adverse Event" ]         ] )       ]     ] [
    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-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-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-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-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 "C201939" ] ;
    fhir:display [ fhir:v "Required Intervention to Prevent Permanent Impairment/damage" ]         ] )       ]     ] [
    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-ig/StructureDefinition/seriousness-criteria"^^xsd:anyURI ]
      ] [
    fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-severity"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:CodeableConcept ;
          ( fhir:coding [
    fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/adverse-event-severity"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "severe" ] ;
    fhir:display [ fhir:v "Severe" ]       ] )     ]
      ] ) ; #
      fhir:status [ fhir:v "completed"] ; #
      fhir:actuality [ fhir:v "actual"] ; #
      fhir:code [
        ( 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:resultingEffect ( [
    fhir:reference [ fhir:v "Condition/AEHepaticFailure" ]
      ] [
    fhir:reference [ fhir:v "Condition/AEHepaticFailurecomplication" ]
      ] ) ; #
      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" ]
      ] ) ; #
      fhir:suspectEntity ( [
    fhir:instance [
    a fhir:Reference ;
    fhir:reference [ fhir:v "MedicationAdministration/medadmin0301" ] ;
    fhir:display [ fhir:v "Study Medication" ]     ] ;
    fhir:causality [
    fhir:entityRelatedness [
            ( fhir:coding [
    fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "C53260" ] ;
    fhir:display [ fhir:v "Related" ]         ] )       ]     ]
      ] ) ; #
      fhir:mitigatingAction ( [
    fhir:item [
    a fhir:Reference ;
    fhir:reference [ fhir:v "MedicationRequest/medicationrequest0301-discontinue" ] ;
    fhir:display [ fhir:v "Medication Request where study drug prescription was discontinued" ]     ]
      ] ) . #