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
<Bundle xmlns="http://hl7.org/fhir">
<id value="ae-bundle-kaitlyn-compass-trial"/>
<meta>
<profile
value="http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-patient-bundle"/>
</meta>
<type value="collection"/>
<entry>
<fullUrl value="http://example.org/patient-example-kaitlyn-b"/>
<resource>
<Patient>
<id value="patient-example-kaitlyn-b"/>
<meta>
<profile
value="http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-cancer-patient"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Patient_patient-example-kaitlyn-b"> </a><p><b>Generated Narrative: Patient</b><a name="patient-example-kaitlyn-b"> </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 Patient "patient-example-kaitlyn-b" </p><p style="margin-bottom: 0px">Profile: <a href="http://hl7.org/fhir/us/mcode/2021May/StructureDefinition-mcode-cancer-patient.html">Cancer Patient</a></p></div><p><b>identifier</b>: Medical Record Number/m123 (use: USUAL)</p><p><b>name</b>: Kaitlyn Bounce </p><p><b>gender</b>: female</p><p><b>birthDate</b>: 1985-02-20</p><p><b>address</b>: 123 Main St Anytown 12345 US </p><h3>Contacts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Telecom</b></td></tr><tr><td style="display: none">*</td><td>ph: 545-123-4560(HOME), <a href="mailto:kaitlynb@example.com">kaitlynb@example.com</a></td></tr></table><h3>Communications</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Language</b></td></tr><tr><td style="display: none">*</td><td>English <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-v3-ietf3066.html">Tags for the Identification of Languages</a>#en-US "English (Region=United States)")</span></td></tr></table></div>
</text>
<identifier>
<use value="usual"/>
<type>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0203"/>
<code value="MR"/>
<display value="Medical Record Number"/>
</coding>
</type>
<system value="http://hospital.example.org"/>
<value value="m123"/>
</identifier>
<name>
<family value="Bounce"/>
<given value="Kaitlyn"/>
</name>
<gender value="female"/>
<birthDate value="1985-02-20"/>
<address>
<line value="123 Main St"/>
<city value="Anytown"/>
<postalCode value="12345"/>
<country value="US"/>
</address>
<contact>
<telecom>
<system value="phone"/>
<value value="545-123-4560"/>
<use value="home"/>
</telecom>
<telecom>
<system value="email"/>
<value value="kaitlynb@example.com"/>
</telecom>
</contact>
<communication>
<language>
<coding>
<system value="urn:ietf:bcp:47"/>
<code value="en-US"/>
<display value="English (Region=United States)"/>
</coding>
<text value="English"/>
</language>
</communication>
</Patient>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/kaitlyn-primary-cancer-condition-ex1"/>
<resource>
<Condition>
<id value="KaitlynPrimaryCancerConditionEx1"/>
<meta>
<profile
value="http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-primary-cancer-condition"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="Condition_KaitlynPrimaryCancerConditionEx1"> </a><p><b>Generated Narrative: Condition</b><a name="KaitlynPrimaryCancerConditionEx1"> </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 Condition "KaitlynPrimaryCancerConditionEx1" </p><p style="margin-bottom: 0px">Profile: <a href="http://hl7.org/fhir/us/mcode/2021May/StructureDefinition-mcode-primary-cancer-condition.html">Primary Cancer Condition</a></p></div><p><b>clinicalStatus</b>: Active <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-condition-clinical.html">Condition Clinical Status Codes</a>#active)</span></p><p><b>verificationStatus</b>: Confirmed <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-condition-ver-status.html">ConditionVerificationStatus</a>#confirmed)</span></p><p><b>category</b>: problem-list-item <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ([not stated]#problem-list-item)</span></p><p><b>code</b>: Malignant neoplasm of female left breast (disorder) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="https://browser.ihtsdotools.org/">SNOMED CT</a>#353431000119107)</span></p><p><b>subject</b>: <a href="#Patient_patient-example-kaitlyn-b">See above (Patient/patient-example-kaitlyn-b)</a></p><p><b>onset</b>: 2019-05-01</p><p><b>asserter</b>: <a href="Practitioner-PractitionerExample1.html">Practitioner/PractitionerExample1</a> " ANYDOC"</p></div>
</text>
<clinicalStatus>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/condition-clinical"/>
<code value="active"/>
<display value="Active"/>
</coding>
</clinicalStatus>
<verificationStatus>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/condition-ver-status"/>
<code value="confirmed"/>
<display value="Confirmed"/>
</coding>
</verificationStatus>
<category>
<coding>
<code value="problem-list-item"/>
</coding>
</category>
<code>
<coding>
<system value="http://snomed.info/sct"/>
<code value="353431000119107"/>
<display
value="Malignant neoplasm of female left breast (disorder)"/>
</coding>
</code>
<subject>🔗
<reference value="Patient/patient-example-kaitlyn-b"/>
</subject>
<onsetDateTime value="2019-05-01"/>
<asserter>🔗
<reference value="Practitioner/PractitionerExample1"/>
</asserter>
</Condition>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/medication-request-example-kadcyla"/>
<resource>
<MedicationRequest>
<id value="medication-request-example-kadcyla"/>
<meta>
<profile
value="http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-cancer-related-medication-request"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicationRequest_medication-request-example-kadcyla"> </a><p><b>Generated Narrative: MedicationRequest</b><a name="medication-request-example-kadcyla"> </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 MedicationRequest "medication-request-example-kadcyla" </p><p style="margin-bottom: 0px">Profile: <a href="http://hl7.org/fhir/us/mcode/2021May/StructureDefinition-mcode-cancer-related-medication-request.html">Cancer-Related Medication Request</a></p></div><p><b>status</b>: active</p><p><b>intent</b>: order</p><p><b>medication</b>: KADCYLA <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-v3-rxNorm.html">RxNorm</a>#1371046)</span></p><p><b>subject</b>: <a href="#Patient_patient-example-kaitlyn-b">See above (Patient/patient-example-kaitlyn-b)</a></p><p><b>authoredOn</b>: 2020-03-12</p><p><b>requester</b>: <a href="Practitioner-PractitionerExample1.html">Practitioner/PractitionerExample1</a> " ANYDOC"</p><p><b>reasonReference</b>: <a href="#Condition_KaitlynPrimaryCancerConditionEx1">See above (Condition/KaitlynPrimaryCancerConditionEx1)</a></p><blockquote><p><b>dosageInstruction</b></p><p><b>text</b>: Kadcyla IV at 3.6mg</p><p><b>timing</b>: Starting 2020-04-01, Once</p><p><b>route</b>: Intravenous route (qualifier value) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="https://browser.ihtsdotools.org/">SNOMED CT</a>#47625008)</span></p><blockquote><p><b>doseAndRate</b></p></blockquote><p><b>maxDosePerAdministration</b>: 1</p></blockquote></div>
</text>
<status value="active"/>
<intent value="order"/>
<medicationCodeableConcept>
<coding>
<system value="http://www.nlm.nih.gov/research/umls/rxnorm"/>
<code value="1371046"/>
<display value="KADCYLA"/>
</coding>
</medicationCodeableConcept>
<subject>🔗
<reference value="Patient/patient-example-kaitlyn-b"/>
</subject>
<authoredOn value="2020-03-12"/>
<requester>🔗
<reference value="Practitioner/PractitionerExample1"/>
</requester>
<reasonReference>🔗
<reference value="Condition/KaitlynPrimaryCancerConditionEx1"/>
</reasonReference>
<dosageInstruction>
<text value="Kadcyla IV at 3.6mg"/>
<timing>
<repeat>
<boundsPeriod>
<start value="2020-04-01"/>
</boundsPeriod>
</repeat>
</timing>
<route>
<coding>
<system value="http://snomed.info/sct"/>
<code value="47625008"/>
<display value="Intravenous route (qualifier value)"/>
</coding>
</route>
<doseAndRate>
<rateQuantity>
<value value="3.6"/>
<unit value="mg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</rateQuantity>
</doseAndRate>
<maxDosePerAdministration>
<value value="1"/>
</maxDosePerAdministration>
</dosageInstruction>
</MedicationRequest>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/medication-request-example-tucatinib"/>
<resource>
<MedicationRequest>
<id value="medication-request-example-tucatinib"/>
<meta>
<profile
value="http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-cancer-related-medication-request"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicationRequest_medication-request-example-tucatinib"> </a><p><b>Generated Narrative: MedicationRequest</b><a name="medication-request-example-tucatinib"> </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 MedicationRequest "medication-request-example-tucatinib" </p><p style="margin-bottom: 0px">Profile: <a href="http://hl7.org/fhir/us/mcode/2021May/StructureDefinition-mcode-cancer-related-medication-request.html">Cancer-Related Medication Request</a></p></div><p><b>status</b>: active</p><p><b>intent</b>: order</p><p><b>medication</b>: tucatinib 150 MG Oral Tablet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-v3-rxNorm.html">RxNorm</a>#2361290)</span></p><p><b>subject</b>: <a href="#Patient_patient-example-kaitlyn-b">See above (Patient/patient-example-kaitlyn-b)</a></p><p><b>authoredOn</b>: 2020-03-12</p><p><b>requester</b>: <a href="Practitioner-PractitionerExample1.html">Practitioner/PractitionerExample1</a> " ANYDOC"</p><p><b>reasonReference</b>: <a href="#Condition_KaitlynPrimaryCancerConditionEx1">See above (Condition/KaitlynPrimaryCancerConditionEx1)</a></p><blockquote><p><b>dosageInstruction</b></p><p><b>text</b>: oral twice a day every day</p><p><b>timing</b>: Starting 2020-04-01, Once</p><p><b>route</b>: Oral route (qualifier value) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="https://browser.ihtsdotools.org/">SNOMED CT</a>#26643006)</span></p><blockquote><p><b>doseAndRate</b></p></blockquote><p><b>maxDosePerAdministration</b>: 2</p></blockquote></div>
</text>
<status value="active"/>
<intent value="order"/>
<medicationCodeableConcept>
<coding>
<system value="http://www.nlm.nih.gov/research/umls/rxnorm"/>
<code value="2361290"/>
<display value="tucatinib 150 MG Oral Tablet"/>
</coding>
</medicationCodeableConcept>
<subject>🔗
<reference value="Patient/patient-example-kaitlyn-b"/>
</subject>
<authoredOn value="2020-03-12"/>
<requester>🔗
<reference value="Practitioner/PractitionerExample1"/>
</requester>
<reasonReference>🔗
<reference value="Condition/KaitlynPrimaryCancerConditionEx1"/>
</reasonReference>
<dosageInstruction>
<text value="oral twice a day every day"/>
<timing>
<repeat>
<boundsPeriod>
<start value="2020-04-01"/>
</boundsPeriod>
</repeat>
</timing>
<route>
<coding>
<system value="http://snomed.info/sct"/>
<code value="26643006"/>
<display value="Oral route (qualifier value)"/>
</coding>
</route>
<doseAndRate>
<rateQuantity>
<value value="150"/>
<unit value="MG"/>
<system value="http://unitsofmeasure.org"/>
<code value="MG"/>
</rateQuantity>
</doseAndRate>
<maxDosePerAdministration>
<value value="2"/>
</maxDosePerAdministration>
</dosageInstruction>
</MedicationRequest>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/medication-administration-kadcyla"/>
<resource>
<MedicationAdministration>
<id value="medication-administration-kadcyla"/>
<meta>
<profile
value="http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-cancer-related-medication-administration"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicationAdministration_medication-administration-kadcyla"> </a><p><b>Generated Narrative: MedicationAdministration</b><a name="medication-administration-kadcyla"> </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 MedicationAdministration "medication-administration-kadcyla" </p><p style="margin-bottom: 0px">Profile: <a href="http://hl7.org/fhir/us/mcode/2021May/StructureDefinition-mcode-cancer-related-medication-administration.html">Cancer-Related Medication Administration</a></p></div><p><b>status</b>: completed</p><p><b>medication</b>: KADCYLA <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-v3-rxNorm.html">RxNorm</a>#1371046)</span></p><p><b>subject</b>: <a href="#Patient_patient-example-kaitlyn-b">See above (Patient/patient-example-kaitlyn-b)</a></p><p><b>effective</b>: 2020-04-01</p><h3>Performers</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Actor</b></td></tr><tr><td style="display: none">*</td><td><a href="Practitioner-practitioner-oncology-nurse-jane.html">Practitioner/practitioner-oncology-nurse-jane</a> " NURSE"</td></tr></table><p><b>reasonReference</b>: <a href="#Condition_KaitlynPrimaryCancerConditionEx1">See above (Condition/KaitlynPrimaryCancerConditionEx1)</a></p><p><b>request</b>: <a href="#MedicationRequest_medication-request-example-kadcyla">See above (MedicationRequest/medication-request-example-kadcyla)</a></p><p><b>note</b>: 3.6mg administered by continuous infusion. Patient tolerated infusion without side effects. (By Practitioner/practitioner-oncology-nurse-jane @2020-04-01)</p><h3>Dosages</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Route</b></td><td><b>Dose</b></td></tr><tr><td style="display: none">*</td><td>Intravenous route (qualifier value) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="https://browser.ihtsdotools.org/">SNOMED CT</a>#47625008)</span></td><td>3.6 mg<span style="background: LightGoldenRodYellow"> (Details: UCUM code mg = 'mg')</span></td></tr></table></div>
</text>
<status value="completed"/>
<medicationCodeableConcept>
<coding>
<system value="http://www.nlm.nih.gov/research/umls/rxnorm"/>
<code value="1371046"/>
<display value="KADCYLA"/>
</coding>
</medicationCodeableConcept>
<subject>🔗
<reference value="Patient/patient-example-kaitlyn-b"/>
</subject>
<effectiveDateTime value="2020-04-01"/>
<performer>
<actor>🔗
<reference value="Practitioner/practitioner-oncology-nurse-jane"/>
</actor>
</performer>
<reasonReference>🔗
<reference value="Condition/KaitlynPrimaryCancerConditionEx1"/>
</reasonReference>
<request>🔗
<reference
value="MedicationRequest/medication-request-example-kadcyla"/>
</request>
<note>
<authorReference>🔗
<reference value="Practitioner/practitioner-oncology-nurse-jane"/>
</authorReference>
<time value="2020-04-01"/>
<text
value="3.6mg administered by continuous infusion. Patient tolerated infusion without side effects."/>
</note>
<dosage>
<route>
<coding>
<system value="http://snomed.info/sct"/>
<code value="47625008"/>
<display value="Intravenous route (qualifier value)"/>
</coding>
</route>
<dose>
<value value="3.6"/>
<unit value="mg"/>
<system value="http://unitsofmeasure.org"/>
<code value="mg"/>
</dose>
</dosage>
</MedicationAdministration>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/medication-administration-tucatinib"/>
<resource>
<MedicationAdministration>
<id value="medication-administration-tucatinib"/>
<meta>
<profile
value="http://hl7.org/fhir/us/mcode/StructureDefinition/mcode-cancer-related-medication-administration"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicationAdministration_medication-administration-tucatinib"> </a><p><b>Generated Narrative: MedicationAdministration</b><a name="medication-administration-tucatinib"> </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 MedicationAdministration "medication-administration-tucatinib" </p><p style="margin-bottom: 0px">Profile: <a href="http://hl7.org/fhir/us/mcode/2021May/StructureDefinition-mcode-cancer-related-medication-administration.html">Cancer-Related Medication Administration</a></p></div><p><b>status</b>: completed</p><p><b>medication</b>: tucatinib 150 MG Oral Tablet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-v3-rxNorm.html">RxNorm</a>#2361290)</span></p><p><b>subject</b>: <a href="#Patient_patient-example-kaitlyn-b">See above (Patient/patient-example-kaitlyn-b)</a></p><p><b>effective</b>: 2020-04-01</p><h3>Performers</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Actor</b></td></tr><tr><td style="display: none">*</td><td><a href="Practitioner-practitioner-oncology-nurse-jane.html">Practitioner/practitioner-oncology-nurse-jane</a> " NURSE"</td></tr></table><p><b>reasonReference</b>: <a href="#Condition_KaitlynPrimaryCancerConditionEx1">See above (Condition/KaitlynPrimaryCancerConditionEx1)</a></p><p><b>request</b>: <a href="#MedicationRequest_medication-request-example-tucatinib">See above (MedicationRequest/medication-request-example-tucatinib)</a></p><p><b>note</b>: Patient took 2 tablets (By Practitioner/practitioner-oncology-nurse-jane @2020-04-01)</p><h3>Dosages</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Route</b></td><td><b>Dose</b></td></tr><tr><td style="display: none">*</td><td>Oral route (qualifier value) <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="https://browser.ihtsdotools.org/">SNOMED CT</a>#26643006)</span></td><td>300 MG<span style="background: LightGoldenRodYellow"> (Details: UCUM code MG = 'MG')</span></td></tr></table></div>
</text>
<status value="completed"/>
<medicationCodeableConcept>
<coding>
<system value="http://www.nlm.nih.gov/research/umls/rxnorm"/>
<code value="2361290"/>
<display value="tucatinib 150 MG Oral Tablet"/>
</coding>
</medicationCodeableConcept>
<subject>🔗
<reference value="Patient/patient-example-kaitlyn-b"/>
</subject>
<effectiveDateTime value="2020-04-01"/>
<performer>
<actor>🔗
<reference value="Practitioner/practitioner-oncology-nurse-jane"/>
</actor>
</performer>
<reasonReference>🔗
<reference value="Condition/KaitlynPrimaryCancerConditionEx1"/>
</reasonReference>
<request>🔗
<reference
value="MedicationRequest/medication-request-example-tucatinib"/>
</request>
<note>
<authorReference>🔗
<reference value="Practitioner/practitioner-oncology-nurse-jane"/>
</authorReference>
<time value="2020-04-01"/>
<text value="Patient took 2 tablets"/>
</note>
<dosage>
<route>
<coding>
<system value="http://snomed.info/sct"/>
<code value="26643006"/>
<display value="Oral route (qualifier value)"/>
</coding>
</route>
<dose>
<value value="300"/>
<unit value="MG"/>
<system value="http://unitsofmeasure.org"/>
<code value="MG"/>
</dose>
</dosage>
</MedicationAdministration>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/ctc-adverse-event-compass-ex1"/>
<resource>
<AdverseEvent>
<id value="ctc-adverse-event-compass-ex1"/>
<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"><a name="AdverseEvent_ctc-adverse-event-compass-ex1"> </a><p><b>Generated Narrative: AdverseEvent</b><a name="ctc-adverse-event-compass-ex1"> </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-ex1" </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>actuality</b>: actual</p><p><b>event</b>: Alanine aminotransferase (ALT) increased at 50 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (MedDRA Am Engl[20.3]#10001551 "Alanine aminotransferase increased")</span></p><p><b>subject</b>: <a href="#Patient_patient-example-kaitlyn-b">See above (Patient/patient-example-kaitlyn-b)</a></p><p><b>date</b>: 2020-04-22</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">See above (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 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><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href="#MedicationAdministration_medication-administration-tucatinib">See above (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">See above (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>
<actuality value="actual"/>
<event>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/MDRAE"/>
<version value="20.3"/>
<code value="10001551"/>
<display value="Alanine aminotransferase increased"/>
</coding>
<text value="Alanine aminotransferase (ALT) increased at 50"/>
</event>
<subject>🔗
<reference value="Patient/patient-example-kaitlyn-b"/>
</subject>
<date value="2020-04-22"/>
<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="C53259"/>
</coding>
<text value="Adverse Event Probably 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>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/ctc-adverse-event-compass-ex1a"/>
<resource>
<AdverseEvent>
<id value="ctc-adverse-event-compass-ex1a"/>
<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"><a name="AdverseEvent_ctc-adverse-event-compass-ex1a"> </a><p><b>Generated Narrative: AdverseEvent</b><a name="ctc-adverse-event-compass-ex1a"> </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-ex1a" </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>: Severe 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>#3)</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>actuality</b>: actual</p><p><b>event</b>: Alanine aminotransferase (ALT) increased to 200 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (MedDRA Am Engl[20.3]#10001551 "Alanine aminotransferase increased")</span></p><p><b>subject</b>: <a href="#Patient_patient-example-kaitlyn-b">See above (Patient/patient-example-kaitlyn-b)</a></p><p><b>date</b>: 2020-05-13</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">See above (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 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><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href="#MedicationAdministration_medication-administration-tucatinib">See above (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">See above (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="3"/>
</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>
<actuality value="actual"/>
<event>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/MDRAE"/>
<version value="20.3"/>
<code value="10001551"/>
<display value="Alanine aminotransferase increased"/>
</coding>
<text value="Alanine aminotransferase (ALT) increased to 200"/>
</event>
<subject>🔗
<reference value="Patient/patient-example-kaitlyn-b"/>
</subject>
<date value="2020-05-13"/>
<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="C53259"/>
</coding>
<text value="Adverse Event Probably 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>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/ctc-adverse-event-compass-ex1b"/>
<resource>
<AdverseEvent>
<id value="ctc-adverse-event-compass-ex1b"/>
<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"><a name="AdverseEvent_ctc-adverse-event-compass-ex1b"> </a><p><b>Generated Narrative: AdverseEvent</b><a name="ctc-adverse-event-compass-ex1b"> </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-ex1b" </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>: 2020-06-10</p><p><b>actuality</b>: actual</p><p><b>event</b>: Alanine aminotransferase (ALT) decreased to 60 <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (MedDRA Am Engl[20.3]#10001551 "Alanine aminotransferase increased")</span></p><p><b>subject</b>: <a href="#Patient_patient-example-kaitlyn-b">See above (Patient/patient-example-kaitlyn-b)</a></p><p><b>date</b>: 2020-05-20</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>: Resolved <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R4/codesystem-adverse-event-outcome.html">AdverseEventOutcome</a>#resolved)</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">See above (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 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><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href="#MedicationAdministration_medication-administration-tucatinib">See above (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">See above (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="2020-06-10"/>
</extension>
<actuality value="actual"/>
<event>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/MDRAE"/>
<version value="20.3"/>
<code value="10001551"/>
<display value="Alanine aminotransferase increased"/>
</coding>
<text value="Alanine aminotransferase (ALT) decreased to 60"/>
</event>
<subject>🔗
<reference value="Patient/patient-example-kaitlyn-b"/>
</subject>
<date value="2020-05-20"/>
<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="resolved"/>
</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="C53259"/>
</coding>
<text value="Adverse Event Probably 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>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/ctc-adverse-event-compass-ex2"/>
<resource>
<AdverseEvent>
<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"><a name="AdverseEvent_ctc-adverse-event-compass-ex2"> </a><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">See above (Patient/patient-example-kaitlyn-b)</a></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">See above (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">See above (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">See above (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>
</resource>
</entry>
<entry>
<fullUrl value="http://example.org/clinical-trial-example-compass"/>
<resource>
<ResearchStudy>
<id value="clinical-trial-example-compass"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="ResearchStudy_clinical-trial-example-compass"> </a><p><b>Generated Narrative: ResearchStudy</b><a name="clinical-trial-example-compass"> </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 ResearchStudy "clinical-trial-example-compass" </p></div><p><b>title</b>: Alliance COMPASS Trial A011801</p><p><b>status</b>: active</p></div>
</text>
<title value="Alliance COMPASS Trial A011801"/>
<status value="active"/>
</ResearchStudy>
</resource>
</entry>
</Bundle>