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-compass-ex1 - XML Representation

Page standards status: Informative

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    <AdverseEvent xmlns="http://hl7.org/fhir">
      <id value="adverse-event-compass-ex1"/>
      <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-ex1"> </a><a name="hcadverse-event-compass-ex1"> </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-ex1&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>: in-progress</p><p><b>actuality</b>: actual</p><p><b>code</b>: Alanine aminotransferase (ALT) increased at 50 <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>: 2020-04-22 --&gt; (ongoing)</p><p><b>resultingEffect</b>: <span>: Reference to Observation of Alanine aminotransferase (ALT) increased at 50</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>: Not recovering/not 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>#C49494)</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><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) increased at 50</span></td></tr></table></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="in-progress"/>
      <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) increased at 50"/>
      </code>
      <subject>🔗
        <reference value="Patient/patient-example-kaitlyn-b"/>
      </subject>
      <occurrencePeriod>
        <start value="2020-04-22"/>
      </occurrencePeriod>
      <resultingEffect>
        <display
                 value="Reference to Observation of Alanine aminotransferase (ALT) increased at 50"/>
      </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="C49494"/>
          <display value="Not recovering/not 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>
      <supportingInfo>
        <itemReference>
          <display
                   value="Supporting info would have context such as an Reference to Observation of Alanine aminotransferase (ALT) increased at 50"/>
        </itemReference>
      </supportingInfo>
    </AdverseEvent>