Adverse Event Clinical Research R4 Backport
1.0.1 - STU1 International flag

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-ex1b - XML Representation

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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-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-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>Resulting Effect</b>: <span>: Reference to Observation of Alanine aminotransferase (ALT) decreased to 60</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) decreased to 60</span></p></blockquote><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><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>Adverse Event resolution date</b>: 2020-06-10</p><p><b>Note</b>: treatment given with reduced dose per protocol guidelines</p><blockquote><p><b>Mitigating Action</b></p><blockquote><p><b>url</b></p><code>item</code></blockquote><p><b>value</b>: <a href="MedicationAdministration-medication-administration-kadcyla-reduced.html">MedicationAdministration/medication-administration-kadcyla-reduced</a></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="MedicationAdministration-medication-administration-tucatinib-reduced.html">MedicationAdministration/medication-administration-tucatinib-reduced</a></p></blockquote><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) 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>date</b>: 2020-05-20</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><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) decreased to 60"/>
    </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) decreased to 60"/>
      </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="C41338"/>
      </coding>
      <text value="Grade 1 Mild 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/resolve-date">
    <valueDateTime value="2020-06-10"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note">
    <valueAnnotation>
      <text
            value="treatment given with reduced dose per protocol guidelines"/>
    </valueAnnotation>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action">
    <extension url="item">
      <valueReference>🔗 
        <reference
                   value="MedicationAdministration/medication-administration-kadcyla-reduced"/>
      </valueReference>
    </extension>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action">
    <extension url="item">
      <valueReference>🔗 
        <reference
                   value="MedicationAdministration/medication-administration-tucatinib-reduced"/>
      </valueReference>
    </extension>
  </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="10001551"/>
      <display value="Alanine aminotransferase increased"/>
    </coding>
    <text value="Alanine aminotransferase (ALT) decreased to 60"/>
  </event>
  <subject>🔗 
    <reference value="Patient/patient-example-kaitlyn-b"/>
  </subject>
  <date value="2020-05-20"/>
  <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>
  <study>🔗 
    <reference value="ResearchStudy/clinical-trial-example-compass"/>
  </study>
</AdverseEvent>