Adverse Event Clinical Research, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-ae-research-ig/ and changes regularly. See the Directory of published versions
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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
# - resource -------------------------------------------------------------------
a fhir:AdverseEvent ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "adverse-event-compass-ex2"] ; #
fhir:meta [
( fhir:profile [
fhir:v "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/AdverseEvent-clinical-research"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/AdverseEvent-clinical-research> ] )
] ; #
fhir:text [
fhir:status [ fhir:v "extensions" ] ;
fhir:div "<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>"
] ; #
fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-grade"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C41338" ] ] ) ;
fhir:text [ fhir:v "Grade 1 Mild Adverse Event" ] ]
] ) ; #
fhir:status [ fhir:v "completed"] ; #
fhir:actuality [ fhir:v "actual"] ; #
fhir:code [
( fhir:coding [
fhir:system [ fhir:v "https://www.meddra.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "10028813" ] ;
fhir:display [ fhir:v "Nausea" ] ] ) ;
fhir:text [ fhir:v "Nausea" ]
] ; #
fhir:subject [
fhir:reference [ fhir:v "Patient/patient-example-kaitlyn-b" ]
] ; #
fhir:occurrence [
a fhir:Period ;
fhir:start [ fhir:v "2020-05-25"^^xsd:date ] ;
fhir:end [ fhir:v "2021-01-21"^^xsd:date ]
] ; #
fhir:resultingEffect ( [
fhir:display [ fhir:v "Reference to Condition instance of Nausea that resolved" ]
] ) ; #
fhir:seriousness [
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"^^xsd:anyURI ] ;
fhir:code [ fhir:v "non-serious" ] ;
fhir:display [ fhir:v "Non-serious" ] ] )
] ; #
fhir:outcome ( [
( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C49494" ] ;
fhir:display [ fhir:v "Not recovering/not resolved" ] ] )
] ) ; #
fhir:recorder [
fhir:reference [ fhir:v "Practitioner/practitioner-oncology-nurse-jane" ]
] ; #
fhir:participant ( [
fhir:function [
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v3-ParticipationType"^^xsd:anyURI ] ;
fhir:code [ fhir:v "AUTHEN" ] ] ) ] ;
fhir:actor [
fhir:reference [ fhir:v "Practitioner/practitioner-owen-oncologist" ] ]
] ) ; #
fhir:study ( [
fhir:reference [ fhir:v "ResearchStudy/clinical-trial-example-compass" ]
] ) ; #
fhir:expectedInResearchStudy [ fhir:v "true"^^xsd:boolean] ; #
fhir:suspectEntity ( [
fhir:instance [
a fhir:Reference ;
fhir:reference [ fhir:v "MedicationAdministration/medication-administration-kadcyla" ] ] ;
fhir:causality [
fhir:entityRelatedness [
( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C53258" ] ;
fhir:display [ fhir:v "Possibly Related" ] ] ) ] ]
] [
fhir:instance [
a fhir:Reference ;
fhir:reference [ fhir:v "MedicationAdministration/medication-administration-tucatinib" ] ] ;
fhir:causality [
fhir:entityRelatedness [
( fhir:coding [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
fhir:code [ fhir:v "C53258" ] ;
fhir:display [ fhir:v "Possibly Related" ] ] ) ] ]
] ) ; #
fhir:mitigatingAction ( [
fhir:item [
a fhir:Reference ;
fhir:reference [ fhir:v "MedicationRequest/medication-request-example-zofran" ] ]
] ) ; #
fhir:supportingInfo ( [
fhir:item [
a fhir:Reference ;
fhir:display [ fhir:v "Supporting info would have context such as an Reference to Condition instance of Nausea, where Condition.status is resolved." ] ]
] ) . #
IG © 2020+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.uv.ae-research-ig#1.0.1 based on FHIR 5.0.0. Generated 2024-04-30
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