HL7 FHIR Implementation Guide: Common Terminology Criteria (CTC) Adverse Events Release 1 - DRAFT
0.0.1 - DRAFT
HL7 FHIR Implementation Guide: Common Terminology Criteria (CTC) Adverse Events Release 1 - DRAFT, published by HL7 International Clinical Interoperability Council. This guide is not an authorized publication; it is the continuous build for version 0.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/standardhealth/fsh-ae/ and changes regularly. See the Directory of published versions
<AdverseEvent xmlns="http://hl7.org/fhir">
<id value="ctc-adverse-event-compass-ex2"/>
<meta>
<profile
value="http://hl7.org/fhir/us/ctcae/StructureDefinition/ctc-adverse-event"/>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: AdverseEvent</b><a name="ctc-adverse-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 "ctc-adverse-event-compass-ex2" </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-ctc-adverse-event.html">CTC Adverse Event</a></p></div><p><b>CTC Adverse Event Grade</b>: Mild Adverse Event <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-ctcae-grade-code-system.html">CTCAE Grade Code System</a>#1)</span></p><blockquote><p><b>Adverse Event Participant</b></p><blockquote><p><b>url</b></p><code>function</code></blockquote><p><b>value</b>: authenticator <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-v3-ParticipationType.html">ParticipationType</a>#AUTHEN)</span></p><blockquote><p><b>url</b></p><code>actor</code></blockquote><p><b>value</b>: <a href="Practitioner-us-core-practitioner-owen-oncologist.html">Practitioner/us-core-practitioner-owen-oncologist</a> " ONCOLOGIST"</p></blockquote><p><b>Adverse Event Expectation</b>: Expected Adverse Event <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C41333)</span></p><p><b>Adverse Event Resolved Date</b>: 2021-01-21</p><p><b>actuality</b>: actual</p><p><b>event</b>: Nausea <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (MedDRA Am Engl[20.3]#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>date</b>: 2020-05-25</p><p><b>seriousness</b>: Non-serious Adverse Event <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C41336)</span></p><p><b>outcome</b>: Ongoing <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R4/codesystem-adverse-event-outcome.html">AdverseEventOutcome</a>#ongoing)</span></p><p><b>recorder</b>: <a href="Practitioner-us-core-practitioner-nancy-oncology-nurse.html">Practitioner/us-core-practitioner-nancy-oncology-nurse</a> " NURSE"</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>Assessment</b></td></tr><tr><td style="display: none">*</td><td>Adverse Event Possibly Related to Intervention <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/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>Assessment</b></td></tr><tr><td style="display: none">*</td><td>Adverse Event Probably Related to Intervention <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html">NCI Thesaurus</a>#C53259)</span></td></tr></table></blockquote><p><b>study</b>: <a href="ResearchStudy-clinical-trial-example-compass.html">ResearchStudy/clinical-trial-example-compass</a></p></div>
</text>
<extension
url="http://hl7.org/fhir/us/ctcae/StructureDefinition/ctcae-grade">
<valueCodeableConcept>
<coding>
<system
value="http://hl7.org/fhir/us/ctcae/CodeSystem/ctcae-grade-code-system"/>
<code value="1"/>
</coding>
</valueCodeableConcept>
</extension>
<extension
url="http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-participant">
<extension url="function">
<valueCodeableConcept>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/v3-ParticipationType"/>
<code value="AUTHEN"/>
</coding>
</valueCodeableConcept>
</extension>
<extension url="actor">
<valueReference>🔗
<reference value="Practitioner/us-core-practitioner-owen-oncologist"/>
</valueReference>
</extension>
</extension>
<extension
url="http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-expectation">
<valueCodeableConcept>
<coding>
<system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C41333"/>
<display value="Expected Adverse Event"/>
</coding>
</valueCodeableConcept>
</extension>
<extension
url="http://hl7.org/fhir/us/ctcae/StructureDefinition/adverse-event-resolved-date">
<valueDateTime value="2021-01-21"/>
</extension>
<actuality value="actual"/>
<event>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/MDRAE"/>
<version value="20.3"/>
<code value="10028813"/>
<display value="Nausea"/>
</coding>
<text value="Nausea"/>
</event>
<subject>🔗
<reference value="Patient/patient-example-kaitlyn-b"/>
</subject>
<date value="2020-05-25"/>
<seriousness>
<coding>
<system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C41336"/>
<display value="Non-serious Adverse Event"/>
</coding>
</seriousness>
<outcome>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/adverse-event-outcome"/>
<code value="ongoing"/>
</coding>
</outcome>
<recorder>🔗
<reference
value="Practitioner/us-core-practitioner-nancy-oncology-nurse"/>
</recorder>
<suspectEntity>
<instance>🔗
<reference
value="MedicationAdministration/medication-administration-kadcyla"/>
</instance>
<causality>
<assessment>
<coding>
<system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C53258"/>
</coding>
<text value="Adverse Event Possibly Related to Intervention"/>
</assessment>
</causality>
</suspectEntity>
<suspectEntity>
<instance>🔗
<reference
value="MedicationAdministration/medication-administration-tucatinib"/>
</instance>
<causality>
<assessment>
<coding>
<system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
<code value="C53259"/>
</coding>
<text value="Adverse Event Probably Related to Intervention"/>
</assessment>
</causality>
</suspectEntity>
<study>🔗
<reference value="ResearchStudy/clinical-trial-example-compass"/>
</study>
</AdverseEvent>