This page is part of the Adverse Event Clinical Research R4 Backport (v1.0.0-ballot: STU 1 Ballot 1) based on FHIR R4. . For a full list of available versions, see the Directory of published versions 
: ClinicalResearchAdverseEventUseCase16 - XML Representation
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<AdverseEvent xmlns="http://hl7.org/fhir">
<id value="ClinicalResearchAdverseEventUseCase16"/>
<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="ClinicalResearchAdverseEventUseCase16"> </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 "ClinicalResearchAdverseEventUseCase16" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-AdverseEvent-clinical-research.html">Adverse Event Clinical Research</a></p></div><p><b>Severity Or Grade</b>: Mild <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-adverse-event-severity-or-grade-cs.html">AdverseEvent Severity or Grade Codes</a>#1)</span></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-MMD.html">MedicationAdministration/study-medication-administration-MMD</a></p><blockquote><p><b>url</b></p><code>causality</code></blockquote></blockquote><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-tylenol.html">MedicationAdministration/medication-administration-tylenol</a></p></blockquote><p><b>Adverse event caused subject to discontinue the study</b>: false</p><p><b>Expected In Research Study</b>: true</p><p><b>Note</b>: Headaches are mild, occur once a week and resolved with Tylenol, but still ongoing. Action taken with the study is dose not chnaged.</p><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>: Headache <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (www.meddra.org#10019211)</span></p><p><b>subject</b>: <a href="Patient-patient-moumic.html">Patient/patient-moumic</a> " EXAMPLE"</p><p><b>date</b>: 2022-02-01</p><p><b>seriousness</b>: Non-serious <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-adverse-event-seriousness.html">AdverseEventSeriousness</a>#non-serious)</span></p><p><b>outcome</b>: Not recovering/not resolved <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.0.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C49494)</span></p><p><b>study</b>: <a href="ResearchStudy-research-study-DISNEY.html">ResearchStudy/research-study-DISNEY</a></p></div>
</text>
<extension
url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/severity-or-grade">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/uv/ae-research-backport-ig/CodeSystem/adverse-event-severity-or-grade-cs"/>
<code value="1"/>
<display value="Mild"/>
</coding>
</valueCodeableConcept>
</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-MMD"/>
</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/mitigating-action">
<extension url="item">
<valueReference>
<reference
value="MedicationAdministration/medication-administration-tylenol"/>
</valueReference>
</extension>
</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/expected-in-research-study">
<valueBoolean value="true"/>
</extension>
<extension
url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note">
<valueAnnotation>
<text
value="Headaches are mild, occur once a week and resolved with Tylenol, but still ongoing. Action taken with the study is dose not chnaged."/>
</valueAnnotation>
</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="Headache"/>
</coding>
</event>
<subject>
<reference value="Patient/patient-moumic"/>
</subject>
<date value="2022-02-01"/>
<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="C49494"/>
<display value="Not recovering/not resolved"/>
</coding>
</outcome>
<study>
<reference value="ResearchStudy/research-study-DISNEY"/>
</study>
</AdverseEvent>
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