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

## : 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-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>Adverse Event 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>Adverse event caused subject to discontinue the study</b>: false</p><p><b>status</b>: completed</p><p><b>actuality</b>: actual</p><p><b>code</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>occurrence</b>: 2021-01-15 --&gt; 2021-01-15</p><p><b>resultingEffect</b>: <a href="Condition-AEModeratehives.html">Condition/AEModeratehives: Moderate hives</a></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>study</b>: <a href="ResearchStudy-research-study-acme.html">ResearchStudy/research-study-acme</a></p><p><b>expectedInResearchStudy</b>: false</p><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href="MedicationAdministration-study-medication-administration-WBY.html">MedicationAdministration/study-medication-administration-WBY</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>Unlikely 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>#C53257)</span></td></tr></table></blockquote><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href="MedicationAdministration-medication-administration-contrast-dye.html">MedicationAdministration/medication-administration-contrast-dye</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>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>#C53260)</span></td></tr></table></blockquote><h3>ContributingFactors</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Item[x]</b></td></tr><tr><td style="display: none">*</td><td><a href="Procedure-clinical-trial-acme-procedure.html">Procedure/clinical-trial-acme-procedure</a></td></tr></table><h3>MitigatingActions</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Item[x]</b></td></tr><tr><td style="display: none">*</td><td><a href="MedicationAdministration-medication-administration-forhives.html">MedicationAdministration/medication-administration-forhives</a></td></tr></table><p><b>note</b>: The action taken with the study treatment was the study drug dose not changed</p></div>
      </text>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-severity">
        <valueCodeableConcept>
          <coding>
            <system
                    value="http://terminology.hl7.org/CodeSystem/adverse-event-severity"/>
            <code value="moderate"/>
            <display value="Moderate"/>
          </coding>
        </valueCodeableConcept>
      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/caused-subject-to-discontinue-study">
        <valueBoolean value="false"/>
      </extension>
      <status value="completed"/>
      <actuality value="actual"/>
      <code>
        <coding>
          <system value="https://www.meddra.org"/>
          <code value="10019211"/>
          <display value="Hypersensitivity reaction"/>
        </coding>
        <text value="Moderate hives"/>
      </code>
      <subject>🔗
        <reference value="Patient/patient-slp"/>
      </subject>
      <occurrencePeriod>
        <start value="2021-01-15"/>
        <end value="2021-01-15"/>
      </occurrencePeriod>
      <resultingEffect>🔗
        <reference value="Condition/AEModeratehives"/>
        <display value="Moderate hives"/>
      </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>
      <study>🔗
        <reference value="ResearchStudy/research-study-acme"/>
      </study>
      <expectedInResearchStudy value="false"/>
      <suspectEntity>
        <instanceReference>🔗
          <reference
                     value="MedicationAdministration/study-medication-administration-WBY"/>
        </instanceReference>
        <causality>
          <entityRelatedness>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C53257"/>
              <display value="Unlikely Related"/>
            </coding>
          </entityRelatedness>
        </causality>
      </suspectEntity>
      <suspectEntity>
        <instanceReference>🔗
          <reference
                     value="MedicationAdministration/medication-administration-contrast-dye"/>
        </instanceReference>
        <causality>
          <entityRelatedness>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C53260"/>
              <display value="Related"/>
            </coding>
          </entityRelatedness>
        </causality>
      </suspectEntity>
      <contributingFactor>
        <itemReference>🔗
          <reference value="Procedure/clinical-trial-acme-procedure"/>
        </itemReference>
      </contributingFactor>
      <mitigatingAction>
        <itemReference>🔗
          <reference
                     value="MedicationAdministration/medication-administration-forhives"/>
        </itemReference>
      </mitigatingAction>
      <note>
        <text
              value="The action taken with the study treatment was the study drug dose not changed"/>
      </note>
    </AdverseEvent>