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 
: ClinicalResearchAdverseEventUseCase17 - XML Representation
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<AdverseEvent xmlns="http://hl7.org/fhir">
<id value="ClinicalResearchAdverseEventUseCase17"/>
<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="ClinicalResearchAdverseEventUseCase17"> </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 "ClinicalResearchAdverseEventUseCase17" </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>: Moderate <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>#2)</span></p><p><b>Adverse Event resolution date</b>: 2021-01-15</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-WBY.html">MedicationAdministration/study-medication-administration-WBY</a></p><blockquote><p><b>url</b></p><code>causality</code></blockquote></blockquote><blockquote><p><b>Suspect Entity</b></p><blockquote><p><b>url</b></p><code>instance</code></blockquote><p><b>value</b>: <a href="MedicationAdministration-medication-administration-contrast-dye.html">MedicationAdministration/medication-administration-contrast-dye</a></p><blockquote><p><b>url</b></p><code>causality</code></blockquote></blockquote><p><b>Expected In Research Study</b>: false</p><p><b>Note</b>: The action taken with the study treatment was the study drug dose not changed</p><p><b>Adverse event caused subject to discontinue the study</b>: false</p><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-forhives.html">MedicationAdministration/medication-administration-forhives</a></p></blockquote><blockquote><p><b>Contributing Factor</b></p><blockquote><p><b>url</b></p><code>item</code></blockquote><p><b>value</b>: <a href="Procedure-clinical-trial-acme-procedure.html">Procedure/clinical-trial-acme-procedure</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>: Moderate hives <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>#C57954 "Grade 2 - Urticaria")</span></p><p><b>subject</b>: <a href="Patient-patient-slp.html">Patient/patient-slp</a> " EXAMPLE"</p><p><b>date</b>: 2021-01-15</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>: C49498"Recovered/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>#C49498"Recovered/Resolved")</span></p><p><b>study</b>: <a href="ResearchStudy-research-study-acme.html">ResearchStudy/research-study-acme</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="2"/>
<display value="Moderate"/>
</coding>
</valueCodeableConcept>
</extension>
<extension
url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resolve-date">
<valueDateTime value="2021-01-15"/>
</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-WBY"/>
</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/suspect-entity">
<extension url="instance">
<valueReference>
<reference
value="MedicationAdministration/medication-administration-contrast-dye"/>
</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/expected-in-research-study">
<valueBoolean value="false"/>
</extension>
<extension
url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note">
<valueAnnotation>
<text
value="The action taken with the study treatment was the study drug dose not changed"/>
</valueAnnotation>
</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/mitigating-action">
<extension url="item">
<valueReference>
<reference
value="MedicationAdministration/medication-administration-forhives"/>
</valueReference>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/contributing-factor">
<extension url="item">
<valueReference>
<reference value="Procedure/clinical-trial-acme-procedure"/>
</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://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C57954"/>
<display value="Grade 2 - Urticaria"/>
</coding>
<text value="Moderate hives"/>
</event>
<subject>
<reference value="Patient/patient-slp"/>
</subject>
<date value="2021-01-15"/>
<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"Recovered/Resolved""/>
</coding>
</outcome>
<study>
<reference value="ResearchStudy/research-study-acme"/>
</study>
</AdverseEvent>
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