This page is part of the Adverse Event Clinical Research (v1.0.1: STU 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions
Page standards status: Informative |
<AdverseEvent xmlns="http://hl7.org/fhir">
<id value="AdverseEventFromProcedureNotStudyDrug"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/AdverseEvent-clinical-research"/>
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<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: AdverseEvent</b><a name="AdverseEventFromProcedureNotStudyDrug"> </a><a name="hcAdverseEventFromProcedureNotStudyDrug"> </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 "AdverseEventFromProcedureNotStudyDrug" </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>: Moderate <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>#moderate)</span></p><p><b>Adverse event caused subject to discontinue the study</b>: false</p><p><b>status</b>: completed</p><p><b>actuality</b>: actual</p><p><b>code</b>: Moderate hives <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>#10019211 "Hypersensitivity reaction")</span></p><p><b>subject</b>: <a href="Patient-patient-slp.html">Patient/patient-slp</a> " EXAMPLE"</p><p><b>occurrence</b>: 2021-01-15 --> 2021-01-15</p><p><b>resultingEffect</b>: <a href="Condition-AEModeratehives.html">Condition/AEModeratehives: Moderate hives</a></p><p><b>seriousness</b>: Non-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>#non-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-acme.html">ResearchStudy/research-study-acme</a></p><p><b>expectedInResearchStudy</b>: false</p><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href="MedicationAdministration-study-medication-administration-WBY.html">MedicationAdministration/study-medication-administration-WBY</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>Unlikely 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>#C53257)</span></td></tr></table></blockquote><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href="MedicationAdministration-medication-administration-contrast-dye.html">MedicationAdministration/medication-administration-contrast-dye</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>ContributingFactors</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="Procedure-clinical-trial-acme-procedure.html">Procedure/clinical-trial-acme-procedure</a></td></tr></table><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="MedicationAdministration-medication-administration-forhives.html">MedicationAdministration/medication-administration-forhives</a></td></tr></table><p><b>note</b>: The action taken with the study treatment was the study drug dose not changed</p></div>
</text>
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url="http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-severity">
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<coding>
<system
value="http://terminology.hl7.org/CodeSystem/adverse-event-severity"/>
<code value="moderate"/>
<display value="Moderate"/>
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<extension
url="http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/caused-subject-to-discontinue-study">
<valueBoolean value="false"/>
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<status value="completed"/>
<actuality value="actual"/>
<code>
<coding>
<system value="https://www.meddra.org"/>
<code value="10019211"/>
<display value="Hypersensitivity reaction"/>
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<text value="Moderate hives"/>
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<subject>🔗
<reference value="Patient/patient-slp"/>
</subject>
<occurrencePeriod>
<start value="2021-01-15"/>
<end value="2021-01-15"/>
</occurrencePeriod>
<resultingEffect>🔗
<reference value="Condition/AEModeratehives"/>
<display value="Moderate hives"/>
</resultingEffect>
<seriousness>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"/>
<code value="non-serious"/>
<display value="Non-serious"/>
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</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-acme"/>
</study>
<expectedInResearchStudy value="false"/>
<suspectEntity>
<instanceReference>🔗
<reference
value="MedicationAdministration/study-medication-administration-WBY"/>
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<causality>
<entityRelatedness>
<coding>
<system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C53257"/>
<display value="Unlikely Related"/>
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</suspectEntity>
<suspectEntity>
<instanceReference>🔗
<reference
value="MedicationAdministration/medication-administration-contrast-dye"/>
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<causality>
<entityRelatedness>
<coding>
<system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C53260"/>
<display value="Related"/>
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<contributingFactor>
<itemReference>🔗
<reference value="Procedure/clinical-trial-acme-procedure"/>
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<mitigatingAction>
<itemReference>🔗
<reference
value="MedicationAdministration/medication-administration-forhives"/>
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<note>
<text
value="The action taken with the study treatment was the study drug dose not changed"/>
</note>
</AdverseEvent>