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
: NonSeriousAdverseEventResearchStudyMed - TTL Representation
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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 "NonSeriousAdverseEventResearchStudyMed"] ; #
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=\"NonSeriousAdverseEventResearchStudyMed\"> </a><a name=\"hcNonSeriousAdverseEventResearchStudyMed\"> </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 "NonSeriousAdverseEventResearchStudyMed" </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>: Mild <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>#mild)</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>: Headache <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)</span></p><p><b>subject</b>: <a href=\"Patient-patient-moumic.html\">Patient/patient-moumic</a> " EXAMPLE"</p><p><b>occurrence</b>: 2022-02-01 --> (ongoing)</p><p><b>resultingEffect</b>: <a href=\"Condition-AEHeadache.html\">Condition/AEHeadache: Mild Headache</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>: 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>study</b>: <a href=\"ResearchStudy-research-study-DISNEY.html\">ResearchStudy/research-study-DISNEY</a></p><p><b>expectedInResearchStudy</b>: true</p><blockquote><p><b>suspectEntity</b></p><p><b>instance</b>: <a href=\"MedicationAdministration-study-medication-administration-MMD.html\">MedicationAdministration/study-medication-administration-MMD</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><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-tylenol.html\">MedicationAdministration/medication-administration-tylenol</a></td></tr></table><p><b>note</b>: Headaches are mild, occur once a week and resolved with Tylenol, but still ongoing. Action taken with the study is dose not changed.</p></div>"
] ; #
fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/ae-severity"^^xsd:anyURI ] ;
fhir:value [
a fhir:CodeableConcept ;
( fhir:coding [
fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/adverse-event-severity"^^xsd:anyURI ] ;
fhir:code [ fhir:v "mild" ] ;
fhir:display [ fhir:v "Mild" ] ] ) ]
] [
fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-ig/StructureDefinition/caused-subject-to-discontinue-study"^^xsd:anyURI ] ;
fhir:value [ fhir:v "false"^^xsd:boolean ]
] ) ; #
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 "10019211" ] ;
fhir:display [ fhir:v "Headache" ] ] )
] ; #
fhir:subject [
fhir:reference [ fhir:v "Patient/patient-moumic" ]
] ; #
fhir:occurrence [
a fhir:Period ;
fhir:start [ fhir:v "2022-02-01"^^xsd:date ]
] ; #
fhir:resultingEffect ( [
fhir:reference [ fhir:v "Condition/AEHeadache" ] ;
fhir:display [ fhir:v "Mild Headache" ]
] ) ; #
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:study ( [
fhir:reference [ fhir:v "ResearchStudy/research-study-DISNEY" ]
] ) ; #
fhir:expectedInResearchStudy [ fhir:v "true"^^xsd:boolean] ; #
fhir:suspectEntity ( [
fhir:instance [
a fhir:Reference ;
fhir:reference [ fhir:v "MedicationAdministration/study-medication-administration-MMD" ] ] ;
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 "C53257" ] ;
fhir:display [ fhir:v "Unlikely Related" ] ] ) ] ]
] ) ; #
fhir:mitigatingAction ( [
fhir:item [
a fhir:Reference ;
fhir:reference [ fhir:v "MedicationAdministration/medication-administration-tylenol" ] ]
] ) ; #
fhir:note ( [
fhir:text [ fhir:v "Headaches are mild, occur once a week and resolved with Tylenol, but still ongoing. Action taken with the study is dose not changed." ]
] ) . #
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