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

## : adverse-event-device-death - 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 "adverse-event-device-death"] ; #
      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=\"adverse-event-device-death\"> </a><a name=\"hcadverse-event-device-death\"> </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;adverse-event-device-death&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-AdverseEvent-clinical-research.html\">Adverse Event Clinical Research</a></p></div><p><b>Adverse Event Grade</b>: Grade 5 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>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>: 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>: 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>: 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>: 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>: 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>: 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>: false</p></blockquote><p><b>status</b>: completed</p><p><b>actuality</b>: actual</p><p><b>category</b>: Device <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-adverse-event-category.html\">AdverseEventCategory</a>#device)</span></p><p><b>code</b>: Patient death due to device explosion <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://browser.ihtsdotools.org/\">SNOMED CT</a>#370903006 &quot;Patient death or serious disability associated with the use or function of a device in patient care, in which the device is used or functions other than as intended (event)&quot;)</span></p><p><b>subject</b>: <a href=\"Patient-patient-example-kaitlyn-b1.html\">Patient/patient-example-kaitlyn-b1</a> &quot; HAMMER&quot;</p><p><b>occurrence</b>: 2020-05-20 --&gt; (ongoing)</p><p><b>resultingEffect</b>: <span>: Condition with Deep puncture wound (disorder) - SNOMED CT code. Note this different than the AdverseEvent.code in this instance.</span></p><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>: Fatal <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><p><b>recorder</b>: <a href=\"Practitioner-practitioner-oncology-nurse-jane.html\">Practitioner/practitioner-oncology-nurse-jane</a> &quot; NURSE&quot;</p><h3>Participants</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Function</b></td><td><b>Actor</b></td></tr><tr><td style=\"display: none\">*</td><td>authenticator <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-v3-ParticipationType.html\">ParticipationType</a>#AUTHEN)</span></td><td><a href=\"Practitioner-practitioner-owen-oncologist.html\">Practitioner/practitioner-owen-oncologist</a> &quot; ONCOLOGIST&quot;</td></tr></table><p><b>study</b>: <a href=\"ResearchStudy-clinical-trial-example-compass.html\">ResearchStudy/clinical-trial-example-compass</a></p><p><b>expectedInResearchStudy</b>: false</p><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href=\"Device-device-infuser.html\">Device/device-infuser</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><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href=\"MedicationAdministration-medication-administration-kadcyla1.html\">MedicationAdministration/medication-administration-kadcyla1</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>Not 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>#C53256)</span></td></tr></table></blockquote><p><b>note</b>: During infusion of kadcyla an infuser exploded, shrapnel from the explosion caused a fatal puncture wound.</p></div>"
      ] ; #
      fhir:extension ( [
    fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-grade"^^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:text [ fhir:v "Grade 5 Death related to adverse event" ]     ]
      ] [
        ( 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 "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 "C48275" ] ;
    fhir:display [ fhir:v "Death Related to Adverse Event" ]         ] )       ]     ] [
    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 "C84266" ] ;
    fhir:display [ fhir:v "Is Life Threatening" ]         ] )       ]     ] [
    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 "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 "false"^^xsd:boolean ]     ] ) ;
    fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria"^^xsd:anyURI ]
      ] ) ; #
      fhir:status [ fhir:v "completed"] ; #
      fhir:actuality [ fhir:v "actual"] ; #
      fhir:category ( [
        ( fhir:coding [
    fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/adverse-event-category"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "device" ] ;
    fhir:display [ fhir:v "Device" ]     ] )
      ] ) ; #
      fhir:code [
        ( fhir:coding [
    a sct:370903006 ;
    fhir:system [ fhir:v "http://snomed.info/sct"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "370903006" ] ;
    fhir:display [ fhir:v "Patient death or serious disability associated with the use or function of a device in patient care, in which the device is used or functions other than as intended (event)" ]     ] ) ;
    fhir:text [ fhir:v "Patient death due to device explosion" ]
      ] ; #
      fhir:subject [
    fhir:reference [ fhir:v "Patient/patient-example-kaitlyn-b1" ]
      ] ; #
      fhir:occurrence [
    a fhir:Period ;
    fhir:start [ fhir:v "2020-05-20"^^xsd:date ]
      ] ; #
      fhir:resultingEffect ( [
    fhir:display [ fhir:v "Condition with Deep puncture wound (disorder) - SNOMED CT code. Note this different than the AdverseEvent.code in this instance." ]
      ] ) ; #
      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 "C48275" ]     ] ) ;
    fhir:text [ fhir:v "Fatal" ]
      ] ) ; #
      fhir:recorder [
    fhir:reference [ fhir:v "Practitioner/practitioner-oncology-nurse-jane" ]
      ] ; #
      fhir:participant ( [
    fhir:function [
          ( fhir:coding [
    fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v3-ParticipationType"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "AUTHEN" ]       ] )     ] ;
    fhir:actor [
    fhir:reference [ fhir:v "Practitioner/practitioner-owen-oncologist" ]     ]
      ] ) ; #
      fhir:study ( [
    fhir:reference [ fhir:v "ResearchStudy/clinical-trial-example-compass" ]
      ] ) ; #
      fhir:expectedInResearchStudy [ fhir:v "false"^^xsd:boolean] ; #
      fhir:suspectEntity ( [
    fhir:instance [
    a fhir:Reference ;
    fhir:reference [ fhir:v "Device/device-infuser" ]     ] ;
    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:instance [
    a fhir:Reference ;
    fhir:reference [ fhir:v "MedicationAdministration/medication-administration-kadcyla1" ]     ] ;
    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 "C53256" ] ;
    fhir:display [ fhir:v "Not Related" ]         ] )       ]     ]
      ] ) ; #
      fhir:note ( [
    fhir:text [ fhir:v "During infusion of kadcyla an infuser exploded, shrapnel from the explosion caused a fatal puncture wound." ]
      ] ) . #