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

: 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-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="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><p><b>Resulting Effect</b>: <a href="Condition-AEHepaticFailure.html">Condition/AEHepaticFailure</a></p><p><b>Resulting Effect</b>: <a href="Condition-AEHepaticFailurecomplication.html">Condition/AEHepaticFailurecomplication</a></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-medadmin0301.html">MedicationAdministration/medadmin0301: Study Medication Use Case 7</a></p><blockquote><p><b>url</b></p><code>causality</code></blockquote></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>: 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><blockquote><p><b>Mitigating Action</b></p><blockquote><p><b>url</b></p><code>item</code></blockquote><p><b>value</b>: <a href="MedicationRequest-medicationrequest0301-discontinue.html">MedicationRequest/medicationrequest0301-discontinue: Medication Request where study drug prescription was discontinued</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>: 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>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>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>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></div>
  </text>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect">
    <valueReference>🔗 
      <reference value="Condition/AEHepaticFailure"/>
    </valueReference>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect">
    <valueReference>🔗 
      <reference value="Condition/AEHepaticFailurecomplication"/>
    </valueReference>
  </extension>
  <extension
             url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity">
    <extension url="instance">
      <valueReference>🔗 
        <reference value="MedicationAdministration/medadmin0301"/>
        <display value="Study Medication Use Case 7"/>
      </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/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-backport-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-backport-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-backport-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-backport-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-backport-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-backport-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-backport-ig/StructureDefinition/mitigating-action">
    <extension url="item">
      <valueReference>🔗 
        <reference
                   value="MedicationRequest/medicationrequest0301-discontinue"/>
        <display
                 value="Medication Request where study drug prescription was discontinued"/>
      </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="http://snomed.info/sct"/>
      <code value="370901008"/>
      <display
               value="Serious reportable event associated with product or device"/>
    </coding>
  </event>
  <subject>🔗 
    <reference value="Patient/ClinicalTrialSubject5"/>
  </subject>
  <detected value="1905-08-23"/>
  <recordedDate value="1905-08-24"/>
  <seriousness>
    <coding>
      <system
              value="http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"/>
      <code value="serious"/>
    </coding>
  </seriousness>
  <severity>
    <coding>
      <system
              value="http://terminology.hl7.org/CodeSystem/adverse-event-severity"/>
      <code value="severe"/>
      <display value="Severe"/>
    </coding>
  </severity>
  <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>
</AdverseEvent>