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

## : AdverseEventFromProcedureNotStudyDrug - XML Representation

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    <AdverseEvent xmlns="http://hl7.org/fhir">
      <id value="AdverseEventFromProcedureNotStudyDrug"/>
      <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="AdverseEventFromProcedureNotStudyDrug"> </a><a name="hcAdverseEventFromProcedureNotStudyDrug"> </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;AdverseEventFromProcedureNotStudyDrug&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>: <a href="Condition-AEModeratehives.html">Condition/AEModeratehives: Moderate hives</a></p><p><b>Adverse Event resolution date</b>: 2021-01-15</p><blockquote><p><b>Suspect Entity</b></p><blockquote><p><b>url</b></p><code>instance</code></blockquote><p><b>value</b>: <a href="MedicationAdministration-study-medication-administration-WBY.html">MedicationAdministration/study-medication-administration-WBY</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-contrast-dye.html">MedicationAdministration/medication-administration-contrast-dye</a></p><blockquote><p><b>url</b></p><code>causality</code></blockquote></blockquote><p><b>Expected In Research Study</b>: false</p><p><b>Note</b>: The action taken with the study treatment was the study drug dose not changed</p><p><b>Adverse event caused subject to discontinue the study</b>: false</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-forhives.html">MedicationAdministration/medication-administration-forhives</a></p></blockquote><blockquote><p><b>Contributing Factor</b></p><blockquote><p><b>url</b></p><code>item</code></blockquote><p><b>value</b>: <a href="Procedure-clinical-trial-acme-procedure.html">Procedure/clinical-trial-acme-procedure</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>: Moderate hives <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>#10019211 &quot;Hypersensitivity reaction&quot;)</span></p><p><b>subject</b>: <a href="Patient-patient-slp.html">Patient/patient-slp</a> &quot; EXAMPLE&quot;</p><p><b>date</b>: 2021-01-15</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>severity</b>: Moderate <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-adverse-event-severity.html">AdverseEventSeverity</a>#moderate)</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>study</b>: <a href="ResearchStudy-research-study-acme.html">ResearchStudy/research-study-acme</a></p></div>
      </text>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect">
        <valueReference>🔗
          <reference value="Condition/AEModeratehives"/>
          <display value="Moderate hives"/>
        </valueReference>
      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resolve-date">
        <valueDateTime value="2021-01-15"/>
      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity">
        <extension url="instance">
          <valueReference>🔗
            <reference
                       value="MedicationAdministration/study-medication-administration-WBY"/>
          </valueReference>
        </extension>
        <extension url="causality">
          <extension url="entityRelatedness">
            <valueCodeableConcept>
              <coding>
                <system
                        value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                <code value="C53257"/>
                <display value="Unlikely 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-contrast-dye"/>
          </valueReference>
        </extension>
        <extension url="causality">
          <extension url="entityRelatedness">
            <valueCodeableConcept>
              <coding>
                <system
                        value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
                <code value="C53260"/>
                <display value="Related"/>
              </coding>
            </valueCodeableConcept>
          </extension>
        </extension>
      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study">
        <valueBoolean value="false"/>
      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note">
        <valueAnnotation>
          <text
                value="The action taken with the study treatment was the study drug dose not changed"/>
        </valueAnnotation>
      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/caused-subject-to-discontinue-study">
        <valueBoolean value="false"/>
      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/mitigating-action">
        <extension url="item">
          <valueReference>🔗
            <reference
                       value="MedicationAdministration/medication-administration-forhives"/>
          </valueReference>
        </extension>
      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/contributing-factor">
        <extension url="item">
          <valueReference>🔗
            <reference value="Procedure/clinical-trial-acme-procedure"/>
          </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="10019211"/>
          <display value="Hypersensitivity reaction"/>
        </coding>
        <text value="Moderate hives"/>
      </event>
      <subject>🔗
        <reference value="Patient/patient-slp"/>
      </subject>
      <date value="2021-01-15"/>
      <seriousness>
        <coding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"/>
          <code value="non-serious"/>
          <display value="Non-serious"/>
        </coding>
      </seriousness>
      <severity>
        <coding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/adverse-event-severity"/>
          <code value="moderate"/>
          <display value="Moderate"/>
        </coding>
      </severity>
      <outcome>
        <coding>
          <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
          <code value="C49498"/>
          <display value="Recovered/Resolved"/>
        </coding>
      </outcome>
      <study>🔗
        <reference value="ResearchStudy/research-study-acme"/>
      </study>
    </AdverseEvent>