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

## : ClinicalTrialSignificantAdverseEvent - XML Representation

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    <AdverseEvent xmlns="http://hl7.org/fhir">
      <id value="ClinicalTrialSignificantAdverseEvent"/>
      <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="ClinicalTrialSignificantAdverseEvent"> </a><a name="hcClinicalTrialSignificantAdverseEvent"> </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;ClinicalTrialSignificantAdverseEvent&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-AdverseEvent-clinical-research.html">Adverse Event Clinical Research</a></p></div><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Results In Persistent Or Significant Disability <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>#C11338)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Requires Inpatient Hospitalization <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>#C83052)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: true</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Death Related to 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>#C48275)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Is Life Threatening <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>#C84266)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: true</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Congenital Anomaly or Birth Defect <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>#C83117)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Other Medically Important Condition <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>#C82521)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: false</p></blockquote><blockquote><p><b>Criteria reviewed in determining serious adverse event</b></p><blockquote><p><b>url</b></p><code>criterionCode</code></blockquote><p><b>value</b>: Required Intervention to Prevent Permanent Impairment/damage <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>#C201939)</span></p><blockquote><p><b>url</b></p><code>criterionPresent</code></blockquote><p><b>value</b>: true</p></blockquote><p><b>Adverse Event Severity</b>: Severe <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>#severe)</span></p><p><b>status</b>: completed</p><p><b>actuality</b>: actual</p><p><b>code</b>: Serious reportable event associated with product or device <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="https://browser.ihtsdotools.org/">SNOMED CT</a>#370901008)</span></p><p><b>subject</b>: <a href="Patient-ClinicalTrialSubject5.html">Patient/ClinicalTrialSubject5</a> &quot; CLINICAL TRIAL&quot;</p><p><b>detected</b>: 1905-08-23</p><p><b>recordedDate</b>: 1905-08-24</p><p><b>resultingEffect</b>: </p><ul><li><a href="Condition-AEHepaticFailure.html">Condition/AEHepaticFailure</a></li><li><a href="Condition-AEHepaticFailurecomplication.html">Condition/AEHepaticFailurecomplication</a></li></ul><p><b>seriousness</b>: 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>#serious)</span></p><p><b>outcome</b>: Recovering/Resolving <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>#C49496)</span></p><p><b>recorder</b>: <span>: Clinical Research Associate</span></p><p><b>study</b>: <span>: NCT1010101</span></p><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href="MedicationAdministration-medadmin0301.html">MedicationAdministration/medadmin0301: Study Medication</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>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="MedicationRequest-medicationrequest0301-discontinue.html">MedicationRequest/medicationrequest0301-discontinue: Medication Request where study drug prescription was discontinued</a></td></tr></table></div>
      </text>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria">
        <extension url="criterionCode">
          <valueCodeableConcept>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C11338"/>
              <display value="Results In Persistent Or Significant Disability"/>
            </coding>
          </valueCodeableConcept>
        </extension>
        <extension url="criterionPresent">
          <valueBoolean value="false"/>
        </extension>
      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria">
        <extension url="criterionCode">
          <valueCodeableConcept>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C83052"/>
              <display value="Requires Inpatient Hospitalization"/>
            </coding>
          </valueCodeableConcept>
        </extension>
        <extension url="criterionPresent">
          <valueBoolean value="true"/>
        </extension>
      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria">
        <extension url="criterionCode">
          <valueCodeableConcept>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C48275"/>
              <display value="Death Related to Adverse Event"/>
            </coding>
          </valueCodeableConcept>
        </extension>
        <extension url="criterionPresent">
          <valueBoolean value="false"/>
        </extension>
      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria">
        <extension url="criterionCode">
          <valueCodeableConcept>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C84266"/>
              <display value="Is Life Threatening"/>
            </coding>
          </valueCodeableConcept>
        </extension>
        <extension url="criterionPresent">
          <valueBoolean value="true"/>
        </extension>
      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria">
        <extension url="criterionCode">
          <valueCodeableConcept>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C83117"/>
              <display value="Congenital Anomaly or Birth Defect"/>
            </coding>
          </valueCodeableConcept>
        </extension>
        <extension url="criterionPresent">
          <valueBoolean value="false"/>
        </extension>
      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria">
        <extension url="criterionCode">
          <valueCodeableConcept>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C82521"/>
              <display value="Other Medically Important Condition"/>
            </coding>
          </valueCodeableConcept>
        </extension>
        <extension url="criterionPresent">
          <valueBoolean value="false"/>
        </extension>
      </extension>
      <extension
                 url="http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/seriousness-criteria">
        <extension url="criterionCode">
          <valueCodeableConcept>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C201939"/>
              <display
                       value="Required Intervention to Prevent Permanent Impairment/damage"/>
            </coding>
          </valueCodeableConcept>
        </extension>
        <extension url="criterionPresent">
          <valueBoolean value="true"/>
        </extension>
      </extension>
      <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="severe"/>
            <display value="Severe"/>
          </coding>
        </valueCodeableConcept>
      </extension>
      <status value="completed"/>
      <actuality value="actual"/>
      <code>
        <coding>
          <system value="http://snomed.info/sct"/>
          <code value="370901008"/>
          <display
                   value="Serious reportable event associated with product or device"/>
        </coding>
      </code>
      <subject>🔗
        <reference value="Patient/ClinicalTrialSubject5"/>
      </subject>
      <detected value="1905-08-23"/>
      <recordedDate value="1905-08-24"/>
      <resultingEffect>🔗
        <reference value="Condition/AEHepaticFailure"/>
      </resultingEffect>
      <resultingEffect>🔗
        <reference value="Condition/AEHepaticFailurecomplication"/>
      </resultingEffect>
      <seriousness>
        <coding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"/>
          <code value="serious"/>
        </coding>
      </seriousness>
      <outcome>
        <coding>
          <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
          <code value="C49496"/>
          <display value="Recovering/Resolving"/>
        </coding>
      </outcome>
      <recorder>
        <display value="Clinical Research Associate"/>
      </recorder>
      <study>
        <display value="NCT1010101"/>
      </study>
      <suspectEntity>
        <instanceReference>🔗
          <reference value="MedicationAdministration/medadmin0301"/>
          <display value="Study Medication"/>
        </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>
      <mitigatingAction>
        <itemReference>🔗
          <reference value="MedicationRequest/medicationrequest0301-discontinue"/>
          <display
                   value="Medication Request where study drug prescription was discontinued"/>
        </itemReference>
      </mitigatingAction>
    </AdverseEvent>