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

## : SeriousAdverseEventResearchStudy - XML Representation

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    <AdverseEvent xmlns="http://hl7.org/fhir">
      <id value="SeriousAdverseEventResearchStudy"/>
      <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="SeriousAdverseEventResearchStudy"> </a><a name="hcSeriousAdverseEventResearchStudy"> </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;SeriousAdverseEventResearchStudy&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>: 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><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 caused subject to discontinue the study</b>: true</p><p><b>status</b>: completed</p><p><b>actuality</b>: actual</p><p><b>code</b>: Gastrointestinal haemorrhage <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>#10017955)</span></p><p><b>subject</b>: <a href="Patient-SCHJO.html">Patient/SCHJO</a> &quot;&quot;</p><p><b>occurrence</b>: 2021-12-02 --&gt; 2021-12-09</p><p><b>resultingEffect</b>: <a href="Condition-GIBleed.html">Condition/GIBleed</a></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>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-XYZ.html">ResearchStudy/research-study-XYZ</a></p><p><b>expectedInResearchStudy</b>: false</p><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href="MedicationAdministration-study-medication-administration-ABC.html">MedicationAdministration/study-medication-administration-ABC</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>Possibly 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>#C53258)</span></td></tr></table></blockquote><blockquote><p><b>mitigatingAction</b></p><p><b>item</b>: <a href="Procedure-procedure-upper-endoscopy.html">Procedure/procedure-upper-endoscopy</a></p></blockquote><blockquote><p><b>mitigatingAction</b></p><p><b>item</b>: study drug withdrawn <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>#C49502 &quot;DRUG WITHDRAWN&quot;)</span></p></blockquote><blockquote><p><b>mitigatingAction</b></p><p><b>item</b>: <a href="MedicationRequest-medicationrequest-for-study-medication-administration-ABC.html">MedicationRequest/medicationrequest-for-study-medication-administration-ABC: Medication Request where study drug prescription was discontinued</a></p></blockquote><h3>SupportingInfos</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Item[x]</b></td></tr><tr><td style="display: none">*</td><td><span>: Supporting info would have context such as an Observation on the drop in hemoglobin</span></td></tr></table><p><b>note</b>: The patient’s hemoglobin dropped to 6.5 g/dL and received 2 units of PRBCs. The patient had an upper endoscopy that showed a moderate amount of bleeding from the esophagus. The site was cauterized, and the patient had no further bleeding after the procedure. The GI bleed resolved within one week after discontinuation of study drug and the patient was discharged on 9-Dec-2021 in good condition.</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="severe"/>
            <display value="Severe"/>
          </coding>
        </valueCodeableConcept>
      </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="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/caused-subject-to-discontinue-study">
        <valueBoolean value="true"/>
      </extension>
      <status value="completed"/>
      <actuality value="actual"/>
      <code>
        <coding>
          <system value="https://www.meddra.org"/>
          <code value="10017955"/>
          <display value="Gastrointestinal haemorrhage"/>
        </coding>
      </code>
      <subject>🔗
        <reference value="Patient/SCHJO"/>
      </subject>
      <occurrencePeriod>
        <start value="2021-12-02"/>
        <end value="2021-12-09"/>
      </occurrencePeriod>
      <resultingEffect>🔗
        <reference value="Condition/GIBleed"/>
      </resultingEffect>
      <seriousness>
        <coding>
          <system
                  value="http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"/>
          <code value="serious"/>
          <display value="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-XYZ"/>
      </study>
      <expectedInResearchStudy value="false"/>
      <suspectEntity>
        <instanceReference>🔗
          <reference
                     value="MedicationAdministration/study-medication-administration-ABC"/>
        </instanceReference>
        <causality>
          <entityRelatedness>
            <coding>
              <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
              <code value="C53258"/>
              <display value="Possibly Related"/>
            </coding>
          </entityRelatedness>
        </causality>
      </suspectEntity>
      <mitigatingAction>
        <itemReference>🔗
          <reference value="Procedure/procedure-upper-endoscopy"/>
        </itemReference>
      </mitigatingAction>
      <mitigatingAction>
        <itemCodeableConcept>
          <coding>
            <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
            <code value="C49502"/>
            <display value="DRUG WITHDRAWN"/>
          </coding>
          <text value="study drug withdrawn"/>
        </itemCodeableConcept>
      </mitigatingAction>
      <mitigatingAction>
        <itemReference>🔗
          <reference
                     value="MedicationRequest/medicationrequest-for-study-medication-administration-ABC"/>
          <display
                   value="Medication Request where study drug prescription was discontinued"/>
        </itemReference>
      </mitigatingAction>
      <supportingInfo>
        <itemReference>
          <display
                   value="Supporting info would have context such as an Observation on the drop in hemoglobin"/>
        </itemReference>
      </supportingInfo>
      <note>
        <text
              value="The patient’s hemoglobin dropped to 6.5 g/dL and received 2 units of PRBCs. The patient had an upper endoscopy that showed a moderate amount of bleeding from the esophagus. The site was cauterized, and the patient had no further bleeding after the procedure. The GI bleed resolved within one week after discontinuation of study drug and the patient was discharged on 9-Dec-2021 in good condition."/>
      </note>
    </AdverseEvent>