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 - XML Representation

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<AdverseEvent xmlns="http://hl7.org/fhir">
  <id value="ClinicalResearchAdverseEventUseCase15"/>
  <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="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>
  </text>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/severity-or-grade">
    <valueCodeableConcept>
      <coding>
        <system
                value="http://hl7.org/fhir/uv/ae-research-backport-ig/CodeSystem/adverse-event-severity-or-grade-cs"/>
        <code value="3"/>
        <display value="Severe"/>
      </coding>
    </valueCodeableConcept>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect">
    <valueReference>
      <reference value="Condition/GIBleedUseCase15"/>
    </valueReference>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity">
    <extension url="instance">
      <valueReference>
        <reference
                   value="MedicationAdministration/study-medication-administration-ABC"/>
      </valueReference>
    </extension>
    <extension url="causality">
      <extension url="entityRelatedness">
        <valueCodeableConcept>
          <coding>
            <system
                    value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
            <code value="C53258"/>
            <display value="Possibly Related"/>
          </coding>
        </valueCodeableConcept>
      </extension>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resolve-date">
    <valueDateTime value="2021-12-09"/>
  </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="resultsInPersistentOrSignificantDisability"/>
        </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="requiresInpatientHospitalization"/>
        </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="C48275"/>
          <display value="resultsInDeath"/>
        </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="C84266"/>
          <display value="isLifeThreatening"/>
        </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="C83117"/>
          <display value="congenitalAnomalyBirthDefect"/>
        </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="otherMedicallyImportantCondition"/>
        </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://hl7.org/fhir/uv/ae-research-backport-ig/CodeSystem/fda-add-seriousness-criteria-cs"/>
          <code value="requiresPreventImpairment"/>
          <display
                   value="Required Intervention to Prevent Permanent Impairment or Damage (Devices)"/>
        </coding>
      </valueCodeableConcept>
    </extension>
    <extension url="criterionPresent">
      <valueBoolean value="true"/>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action">
    <extension url="item">
      <valueReference>
        <reference value="Procedure/procedure-upper-endoscopy"/>
      </valueReference>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action">
    <extension url="item">
      <valueCodeableConcept>
        <coding>
          <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
          <code value="C49502"/>
          <display value="DRUG WITHDRAWN"/>
        </coding>
        <text value="study drug withdrawn"/>
      </valueCodeableConcept>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action">
    <extension url="item">
      <valueReference>
        <reference
                   value="MedicationRequest/medicationrequest-for-study-medication-administration-ABC"/>
        <display
                 value="Medication Request where study drug prescription was discontinued"/>
      </valueReference>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/caused-subject-to-discontinue-study">
    <valueBoolean value="true"/>
  </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/supporting-info">
    <extension url="item">
      <valueReference>
        <display
                 value="Supporting info would have context such as an Observation on the drop in hemoglobin"/>
      </valueReference>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note">
    <valueAnnotation>
      <text
            value="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."/>
    </valueAnnotation>
  </extension>
  <modifierExtension
                     url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status">
    <valueCode value="completed"/>
  </modifierExtension>
  <actuality value="actual"/>
  <event>
    <coding>
      <system value="https://www.meddra.org"/>
      <code value="10017955"/>
      <display value="Gastrointestinal haemorrhage"/>
    </coding>
  </event>
  <subject>
    <reference value="Patient/SCHJO"/>
  </subject>
  <date value="2021-12-02"/>
  <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="C49498&quot;Recovered/Resolved&quot;"/>
    </coding>
  </outcome>
  <study>
    <reference value="ResearchStudy/research-study-XYZ"/>
  </study>
</AdverseEvent>