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-compass-ex1a - XML Representation

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    <AdverseEvent xmlns="http://hl7.org/fhir">
      <id value="adverse-event-compass-ex1a"/>
      <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-compass-ex1a"> </a><a name="hcadverse-event-compass-ex1a"> </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-ex1a&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-AdverseEvent-clinical-research.html">Adverse Event Clinical Research</a></p></div><p><b>Resulting Effect</b>: <span>: Reference to Observation of Alanine aminotransferase (ALT) increased at 200</span></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 Reference to Observation of Alanine aminotransferase (ALT) increased at 200</span></p></blockquote><p><b>Adverse Event Grade</b>: Grade 3 Severe 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>#C41340)</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="MedicationAdministration-medication-administration-kadcyla.html">MedicationAdministration/medication-administration-kadcyla</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-tucatinib.html">MedicationAdministration/medication-administration-tucatinib</a></p><blockquote><p><b>url</b></p><code>causality</code></blockquote></blockquote><p><b>Expected In Research Study</b>: true</p><p><b>Note</b>: treatment held today per protocol guidelines and the patient was scheduled to return in one week for repeat lab work</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>: Alanine aminotransferase (ALT) increased to 200 <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>date</b>: 2020-05-13</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><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/resultingEffect">
        <valueReference>
          <display
                   value="Reference to Observation of Alanine aminotransferase (ALT) increased at 200"/>
        </valueReference>
      </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 Reference to Observation of Alanine aminotransferase (ALT) increased at 200"/>
          </valueReference>
        </extension>
      </extension>
      <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="C41340"/>
          </coding>
          <text value="Grade 3 Severe Adverse Event"/>
        </valueCodeableConcept>
      </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="MedicationAdministration/medication-administration-kadcyla"/>
          </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/suspect-entity">
        <extension url="instance">
          <valueReference>🔗
            <reference
                       value="MedicationAdministration/medication-administration-tucatinib"/>
          </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/expected-in-research-study">
        <valueBoolean value="true"/>
      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note">
        <valueAnnotation>
          <text
                value="treatment held today per protocol guidelines and the patient was scheduled to return in one week for repeat lab work"/>
        </valueAnnotation>
      </extension>
      <modifierExtension
                         url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status">
        <valueCode value="in-progress"/>
      </modifierExtension>
      <actuality value="actual"/>
      <event>
        <coding>
          <system value="https://www.meddra.org"/>
          <code value="10001551"/>
          <display value="Alanine aminotransferase increased"/>
        </coding>
        <text value="Alanine aminotransferase (ALT) increased to 200"/>
      </event>
      <subject>🔗
        <reference value="Patient/patient-example-kaitlyn-b"/>
      </subject>
      <date value="2020-05-13"/>
      <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>
      <study>🔗
        <reference value="ResearchStudy/clinical-trial-example-compass"/>
      </study>
    </AdverseEvent>