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 in its permanent home (it will always be available at this URL). 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="adverse-event-compass-ex2"/>
<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="adverse-event-compass-ex2"> </a><a name="hcadverse-event-compass-ex2"> </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 "adverse-event-compass-ex2" </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 Grade</b>: Grade 1 Mild 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>#C41338)</span></p><p><b>status</b>: completed</p><p><b>actuality</b>: actual</p><p><b>code</b>: Nausea <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>#10028813)</span></p><p><b>subject</b>: <a href="Patient-patient-example-kaitlyn-b.html">Patient/patient-example-kaitlyn-b</a> " BOUNCE"</p><p><b>occurrence</b>: 2020-05-25 --> 2021-01-21</p><p><b>resultingEffect</b>: <span>: Reference to Condition instance of Nausea that resolved</span></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>: Not recovering/not 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>#C49494)</span></p><p><b>recorder</b>: <a href="Practitioner-practitioner-oncology-nurse-jane.html">Practitioner/practitioner-oncology-nurse-jane</a> " NURSE"</p><h3>Participants</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Function</b></td><td><b>Actor</b></td></tr><tr><td style="display: none">*</td><td>authenticator <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-ParticipationType.html">ParticipationType</a>#AUTHEN)</span></td><td><a href="Practitioner-practitioner-owen-oncologist.html">Practitioner/practitioner-owen-oncologist</a> " ONCOLOGIST"</td></tr></table><p><b>study</b>: <a href="ResearchStudy-clinical-trial-example-compass.html">ResearchStudy/clinical-trial-example-compass</a></p><p><b>expectedInResearchStudy</b>: true</p><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href="MedicationAdministration-medication-administration-kadcyla.html">MedicationAdministration/medication-administration-kadcyla</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>suspectEntity</b></p><p><b>instance</b>: <a href="MedicationAdministration-medication-administration-tucatinib.html">MedicationAdministration/medication-administration-tucatinib</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><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="MedicationRequest-medication-request-example-zofran.html">MedicationRequest/medication-request-example-zofran</a></td></tr></table><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 Reference to Condition instance of Nausea, where Condition.status is resolved.</span></td></tr></table></div>
</text>
<extension
url="http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-grade">
<valueCodeableConcept>
<coding>
<system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C41338"/>
</coding>
<text value="Grade 1 Mild Adverse Event"/>
</valueCodeableConcept>
</extension>
<status value="completed"/>
<actuality value="actual"/>
<code>
<coding>
<system value="https://www.meddra.org"/>
<code value="10028813"/>
<display value="Nausea"/>
</coding>
<text value="Nausea"/>
</code>
<subject>🔗
<reference value="Patient/patient-example-kaitlyn-b"/>
</subject>
<occurrencePeriod>
<start value="2020-05-25"/>
<end value="2021-01-21"/>
</occurrencePeriod>
<resultingEffect>
<display value="Reference to Condition instance of Nausea that resolved"/>
</resultingEffect>
<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>
<recorder>🔗
<reference value="Practitioner/practitioner-oncology-nurse-jane"/>
</recorder>
<participant>
<function>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-ParticipationType"/>
<code value="AUTHEN"/>
</coding>
</function>
<actor>🔗
<reference value="Practitioner/practitioner-owen-oncologist"/>
</actor>
</participant>
<study>🔗
<reference value="ResearchStudy/clinical-trial-example-compass"/>
</study>
<expectedInResearchStudy value="true"/>
<suspectEntity>
<instanceReference>🔗
<reference
value="MedicationAdministration/medication-administration-kadcyla"/>
</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>
<suspectEntity>
<instanceReference>🔗
<reference
value="MedicationAdministration/medication-administration-tucatinib"/>
</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="MedicationRequest/medication-request-example-zofran"/>
</itemReference>
</mitigatingAction>
<supportingInfo>
<itemReference>
<display
value="Supporting info would have context such as an Reference to Condition instance of Nausea, where Condition.status is resolved."/>
</itemReference>
</supportingInfo>
</AdverseEvent>