Adverse Event Clinical Research
1.0.1 - STU1 International flag

This page is part of the Adverse Event Clinical Research (v1.0.1: STU 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions

: adverse-event-compass-ex1b - XML Representation

Page standards status: Informative

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<AdverseEvent xmlns="http://hl7.org/fhir">
  <id value="adverse-event-compass-ex1b"/>
  <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="adverse-event-compass-ex1b"> </a><a name="hcadverse-event-compass-ex1b"> </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-compass-ex1b&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 1 Mild 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>#C41338)</span></p><p><b>status</b>: completed</p><p><b>actuality</b>: actual</p><p><b>code</b>: Alanine aminotransferase (ALT) decreased to 60 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-mdr.html">Medical Dictionary for Regulatory Activities</a>#10001551 &quot;Alanine aminotransferase increased&quot;)</span></p><p><b>subject</b>: <a href="Patient-patient-example-kaitlyn-b.html">Patient/patient-example-kaitlyn-b</a> &quot; BOUNCE&quot;</p><p><b>occurrence</b>: 2020-05-20 --&gt; 2020-06-10</p><p><b>resultingEffect</b>: <span>: Reference to Observation of Alanine aminotransferase (ALT) decreased to 60</span></p><p><b>seriousness</b>: Non-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>#non-serious)</span></p><p><b>outcome</b>: Recovered/Resolved <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>#C49498)</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>: true</p><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href="MedicationAdministration-medication-administration-kadcyla.html">MedicationAdministration/medication-administration-kadcyla</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>Possibly 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>#C53258)</span></td></tr></table></blockquote><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href="MedicationAdministration-medication-administration-tucatinib.html">MedicationAdministration/medication-administration-tucatinib</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>Possibly 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>#C53258)</span></td></tr></table></blockquote><blockquote><p><b>mitigatingAction</b></p><p><b>item</b>: <a href="MedicationAdministration-medication-administration-kadcyla-reduced.html">MedicationAdministration/medication-administration-kadcyla-reduced</a></p></blockquote><blockquote><p><b>mitigatingAction</b></p><p><b>item</b>: <a href="MedicationAdministration-medication-administration-tucatinib-reduced.html">MedicationAdministration/medication-administration-tucatinib-reduced</a></p></blockquote><h3>SupportingInfos</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Item[x]</b></td></tr><tr><td style="display: none">*</td><td><span>: Supporting info would have context such as an Reference to Observation of Alanine aminotransferase (ALT) decreased to 60</span></td></tr></table><p><b>note</b>: treatment given with reduced dose per protocol guidelines</p></div>
  </text>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-grade">
    <valueCodeableConcept>
      <coding>
        <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
        <code value="C41338"/>
      </coding>
      <text value="Grade 1 Mild Adverse Event"/>
    </valueCodeableConcept>
  </extension>
  <status value="completed"/>
  <actuality value="actual"/>
  <code>
    <coding>
      <system value="https://www.meddra.org"/>
      <code value="10001551"/>
      <display value="Alanine aminotransferase increased"/>
    </coding>
    <text value="Alanine aminotransferase (ALT) decreased to 60"/>
  </code>
  <subject>🔗 
    <reference value="Patient/patient-example-kaitlyn-b"/>
  </subject>
  <occurrencePeriod>
    <start value="2020-05-20"/>
    <end value="2020-06-10"/>
  </occurrencePeriod>
  <resultingEffect>
    <display
             value="Reference to Observation of Alanine aminotransferase (ALT) decreased to 60"/>
  </resultingEffect>
  <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="C49498"/>
      <display value="Recovered/Resolved"/>
    </coding>
  </outcome>
  <recorder>🔗 
    <reference value="Practitioner/practitioner-oncology-nurse-jane"/>
  </recorder>
  <participant>
    <function>
      <coding>
        <system
                value="http://terminology.hl7.org/CodeSystem/v3-ParticipationType"/>
        <code value="AUTHEN"/>
      </coding>
    </function>
    <actor>🔗 
      <reference value="Practitioner/practitioner-owen-oncologist"/>
    </actor>
  </participant>
  <study>🔗 
    <reference value="ResearchStudy/clinical-trial-example-compass"/>
  </study>
  <expectedInResearchStudy value="true"/>
  <suspectEntity>
    <instanceReference>🔗 
      <reference
                 value="MedicationAdministration/medication-administration-kadcyla"/>
    </instanceReference>
    <causality>
      <entityRelatedness>
        <coding>
          <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
          <code value="C53258"/>
          <display value="Possibly Related"/>
        </coding>
      </entityRelatedness>
    </causality>
  </suspectEntity>
  <suspectEntity>
    <instanceReference>🔗 
      <reference
                 value="MedicationAdministration/medication-administration-tucatinib"/>
    </instanceReference>
    <causality>
      <entityRelatedness>
        <coding>
          <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
          <code value="C53258"/>
          <display value="Possibly Related"/>
        </coding>
      </entityRelatedness>
    </causality>
  </suspectEntity>
  <mitigatingAction>
    <itemReference>🔗 
      <reference
                 value="MedicationAdministration/medication-administration-kadcyla-reduced"/>
    </itemReference>
  </mitigatingAction>
  <mitigatingAction>
    <itemReference>🔗 
      <reference
                 value="MedicationAdministration/medication-administration-tucatinib-reduced"/>
    </itemReference>
  </mitigatingAction>
  <supportingInfo>
    <itemReference>
      <display
               value="Supporting info would have context such as an Reference to Observation of Alanine aminotransferase (ALT) decreased to 60"/>
    </itemReference>
  </supportingInfo>
  <note>
    <text value="treatment given with reduced dose per protocol guidelines"/>
  </note>
</AdverseEvent>