Adverse Event Clinical Research
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This page is part of the Adverse Event Clinical Research (v1.0.0-ballot: STU 1 Ballot 1) based on FHIR v5.0.0. . For a full list of available versions, see the Directory of published versions

: ClinicalResearchAdverseEventUseCase16 - XML Representation

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<AdverseEvent xmlns="http://hl7.org/fhir">
  <id value="ClinicalResearchAdverseEventUseCase16"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/uv/ae-research-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="ClinicalResearchAdverseEventUseCase16"> </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;ClinicalResearchAdverseEventUseCase16&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>: Mild <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>#1)</span></p><p><b>Adverse event caused subject to discontinue the study</b>: false</p><p><b>status</b>: completed</p><p><b>actuality</b>: actual</p><p><b>code</b>: Headache <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (www.meddra.org#10019211)</span></p><p><b>subject</b>: <a href="Patient-patient-moumic.html">Patient/patient-moumic</a> &quot; EXAMPLE&quot;</p><p><b>occurrence</b>: 2022-02-01 --&gt; (ongoing)</p><p><b>seriousness</b>: Non-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>#non-serious)</span></p><p><b>outcome</b>: Not recovering/not resolved <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>#C49494)</span></p><p><b>study</b>: <a href="ResearchStudy-research-study-DISNEY.html">ResearchStudy/research-study-DISNEY</a></p><p><b>expectedInResearchStudy</b>: true</p><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href="MedicationAdministration-study-medication-administration-MMD.html">MedicationAdministration/study-medication-administration-MMD</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>Unlikely Related <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>#C53257)</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="MedicationAdministration-medication-administration-tylenol.html">MedicationAdministration/medication-administration-tylenol</a></td></tr></table><p><b>note</b>: Headaches are mild, occur once a week and resolved with Tylenol, but still ongoing. Action taken with the study is dose not changed.</p></div>
  </text>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/severity-or-grade">
    <valueCodeableConcept>
      <coding>
        <system
                value="http://hl7.org/fhir/uv/ae-research-ig/CodeSystem/adverse-event-severity-or-grade-cs"/>
        <code value="1"/>
        <display value="Mild"/>
      </coding>
    </valueCodeableConcept>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/caused-subject-to-discontinue-study">
    <valueBoolean value="false"/>
  </extension>
  <status value="completed"/>
  <actuality value="actual"/>
  <code>
    <coding>
      <system value="https://www.meddra.org"/>
      <code value="10019211"/>
      <display value="Headache"/>
    </coding>
  </code>
  <subject>
    <reference value="Patient/patient-moumic"/>
  </subject>
  <occurrencePeriod>
    <start value="2022-02-01"/>
  </occurrencePeriod>
  <seriousness>
    <coding>
      <system
              value="http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"/>
      <code value="non-serious"/>
      <display value="Non-serious"/>
    </coding>
  </seriousness>
  <outcome>
    <coding>
      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <code value="C49494"/>
      <display value="Not recovering/not resolved"/>
    </coding>
  </outcome>
  <study>
    <reference value="ResearchStudy/research-study-DISNEY"/>
  </study>
  <expectedInResearchStudy value="true"/>
  <suspectEntity>
    <instanceReference>
      <reference
                 value="MedicationAdministration/study-medication-administration-MMD"/>
    </instanceReference>
    <causality>
      <entityRelatedness>
        <coding>
          <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
          <code value="C53257"/>
          <display value="Unlikely Related"/>
        </coding>
      </entityRelatedness>
    </causality>
  </suspectEntity>
  <mitigatingAction>
    <itemReference>
      <reference
                 value="MedicationAdministration/medication-administration-tylenol"/>
    </itemReference>
  </mitigatingAction>
  <note>
    <text
          value="Headaches are mild, occur once a week and resolved with Tylenol, but still ongoing. Action taken with the study is dose not changed."/>
  </note>
</AdverseEvent>