Adverse Event Clinical Research R4 Backport
1.0.1 - STU1

Adverse Event Clinical Research R4 Backport, 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-backport-ig/ and changes regularly. See the Directory of published versions

## : adverse-event-device-death - XML Representation

Raw xml | Download

    <AdverseEvent xmlns="http://hl7.org/fhir">
      <id value="adverse-event-device-death"/>
      <meta>
        <profile
                 value="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/AdverseEvent-clinical-research"/>
      </meta>
      <text>
        <status value="extensions"/>
        <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>Resulting Effect</b>: <span>: Condition with Deep puncture wound (disorder) - SNOMED CT code. Note this different than the AdverseEvent.code in this instance.</span></p><blockquote><p><b>Participant</b></p><blockquote><p><b>url</b></p><code>function</code></blockquote><p><b>value</b>: 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></p><blockquote><p><b>url</b></p><code>actor</code></blockquote><p><b>value</b>: <a href="Practitioner-practitioner-owen-oncologist.html">Practitioner/practitioner-owen-oncologist</a> &quot; ONCOLOGIST&quot;</p></blockquote><blockquote><p><b>Suspect Entity</b></p><blockquote><p><b>url</b></p><code>instance</code></blockquote><p><b>value</b>: <a href="Device-device-infuser.html">Device/device-infuser</a></p><blockquote><p><b>url</b></p><code>causality</code></blockquote></blockquote><blockquote><p><b>Suspect Entity</b></p><blockquote><p><b>url</b></p><code>instance</code></blockquote><p><b>value</b>: <a href="MedicationAdministration-medication-administration-kadcyla1.html">MedicationAdministration/medication-administration-kadcyla1</a></p><blockquote><p><b>url</b></p><code>causality</code></blockquote></blockquote><p><b>Expected In Research Study</b>: false</p><p><b>Note</b>: During infusion of kadcyla an infuser exploded, shrapnel from the explosion caused a fatal puncture wound.</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>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>event</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>date</b>: 2020-05-20</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><p><b>study</b>: <a href="ResearchStudy-clinical-trial-example-compass.html">ResearchStudy/clinical-trial-example-compass</a></p></div>
      </text>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/ae-grade">
        <valueCodeableConcept>
          <coding>
            <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
            <code value="C48275"/>
          </coding>
          <text value="Grade 5 Death related to adverse event"/>
        </valueCodeableConcept>
      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria">
        <extension url="criterionCode">
          <valueCodeableConcept>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C11338"/>
              <display value="Results In Persistent Or Significant Disability"/>
            </coding>
          </valueCodeableConcept>
        </extension>
        <extension url="criterionPresent">
          <valueBoolean value="false"/>
        </extension>
      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria">
        <extension url="criterionCode">
          <valueCodeableConcept>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C83052"/>
              <display value="Requires Inpatient Hospitalization"/>
            </coding>
          </valueCodeableConcept>
        </extension>
        <extension url="criterionPresent">
          <valueBoolean value="false"/>
        </extension>
      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria">
        <extension url="criterionCode">
          <valueCodeableConcept>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C48275"/>
              <display value="Death Related to Adverse Event"/>
            </coding>
          </valueCodeableConcept>
        </extension>
        <extension url="criterionPresent">
          <valueBoolean value="true"/>
        </extension>
      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria">
        <extension url="criterionCode">
          <valueCodeableConcept>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C84266"/>
              <display value="Is Life Threatening"/>
            </coding>
          </valueCodeableConcept>
        </extension>
        <extension url="criterionPresent">
          <valueBoolean value="false"/>
        </extension>
      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria">
        <extension url="criterionCode">
          <valueCodeableConcept>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C83117"/>
              <display value="Congenital Anomaly or Birth Defect"/>
            </coding>
          </valueCodeableConcept>
        </extension>
        <extension url="criterionPresent">
          <valueBoolean value="false"/>
        </extension>
      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria">
        <extension url="criterionCode">
          <valueCodeableConcept>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C82521"/>
              <display value="Other Medically Important Condition"/>
            </coding>
          </valueCodeableConcept>
        </extension>
        <extension url="criterionPresent">
          <valueBoolean value="false"/>
        </extension>
      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria">
        <extension url="criterionCode">
          <valueCodeableConcept>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C201939"/>
              <display
                       value="Required Intervention to Prevent Permanent Impairment/damage"/>
            </coding>
          </valueCodeableConcept>
        </extension>
        <extension url="criterionPresent">
          <valueBoolean value="false"/>
        </extension>
      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect">
        <valueReference>
          <display
                   value="Condition with Deep puncture wound (disorder) - SNOMED CT code. Note this different than the AdverseEvent.code in this instance."/>
        </valueReference>
      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/participant">
        <extension url="function">
          <valueCodeableConcept>
            <coding>
              <system
                      value="http://terminology.hl7.org/CodeSystem/v3-ParticipationType"/>
              <code value="AUTHEN"/>
            </coding>
          </valueCodeableConcept>
        </extension>
        <extension url="actor">
          <valueReference>🔗
            <reference value="Practitioner/practitioner-owen-oncologist"/>
          </valueReference>
        </extension>
      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity">
        <extension url="instance">
          <valueReference>🔗
            <reference value="Device/device-infuser"/>
          </valueReference>
        </extension>
        <extension url="causality">
          <extension url="entityRelatedness">
            <valueCodeableConcept>
              <coding>
                <system
                        value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                <code value="C53260"/>
                <display value="Related"/>
              </coding>
            </valueCodeableConcept>
          </extension>
        </extension>
      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity">
        <extension url="instance">
          <valueReference>🔗
            <reference
                       value="MedicationAdministration/medication-administration-kadcyla1"/>
          </valueReference>
        </extension>
        <extension url="causality">
          <extension url="entityRelatedness">
            <valueCodeableConcept>
              <coding>
                <system
                        value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                <code value="C53256"/>
                <display value="Not Related"/>
              </coding>
            </valueCodeableConcept>
          </extension>
        </extension>
      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study">
        <valueBoolean value="false"/>
      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note">
        <valueAnnotation>
          <text
                value="During infusion of kadcyla an infuser exploded, shrapnel from the explosion caused a fatal puncture wound."/>
        </valueAnnotation>
      </extension>
      <modifierExtension
                         url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status">
        <valueCode value="completed"/>
      </modifierExtension>
      <actuality value="actual"/>
      <category>
        <coding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/adverse-event-category"/>
          <code value="device"/>
          <display value="Device"/>
        </coding>
      </category>
      <event>
        <coding>
          <system value="http://snomed.info/sct"/>
          <code value="370903006"/>
          <display
                   value="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)"/>
        </coding>
        <text value="Patient death due to device explosion"/>
      </event>
      <subject>🔗
        <reference value="Patient/patient-example-kaitlyn-b1"/>
      </subject>
      <date value="2020-05-20"/>
      <seriousness>
        <coding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"/>
          <code value="serious"/>
          <display value="Serious"/>
        </coding>
      </seriousness>
      <outcome>
        <coding>
          <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
          <code value="C48275"/>
        </coding>
        <text value="Fatal"/>
      </outcome>
      <recorder>🔗
        <reference value="Practitioner/practitioner-oncology-nurse-jane"/>
      </recorder>
      <study>🔗
        <reference value="ResearchStudy/clinical-trial-example-compass"/>
      </study>
    </AdverseEvent>