Adverse Event Clinical Research R4 Backport
1.0.1 - STU1

Adverse Event Clinical Research R4 Backport, 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-backport-ig/ and changes regularly. See the Directory of published versions

## : adverse-event-compass-ex1a - 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 "adverse-event-compass-ex1a"] ; #
      fhir:meta [
        ( fhir:profile [
    fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/AdverseEvent-clinical-research"^^xsd:anyURI ;
    fhir:link <http://hl7.org/fhir/uv/ae-research-backport-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-ex1a\"> </a><a name=\"hcadverse-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 &quot;adverse-event-compass-ex1a&quot; </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-AdverseEvent-clinical-research.html\">Adverse Event Clinical Research</a></p></div><p><b>Resulting Effect</b>: <span>: Reference to Observation of Alanine aminotransferase (ALT) increased at 200</span></p><blockquote><p><b>Supporting information relevant to the event</b></p><blockquote><p><b>url</b></p><code>item</code></blockquote><p><b>value</b>: <span>: Supporting info would have context such as an Reference to Observation of Alanine aminotransferase (ALT) increased at 200</span></p></blockquote><p><b>Adverse Event Grade</b>: Grade 3 Severe 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>#C41340)</span></p><blockquote><p><b>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/5.5.0/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-practitioner-owen-oncologist.html\">Practitioner/practitioner-owen-oncologist</a> &quot; ONCOLOGIST&quot;</p></blockquote><blockquote><p><b>Suspect Entity</b></p><blockquote><p><b>url</b></p><code>instance</code></blockquote><p><b>value</b>: <a href=\"MedicationAdministration-medication-administration-kadcyla.html\">MedicationAdministration/medication-administration-kadcyla</a></p><blockquote><p><b>url</b></p><code>causality</code></blockquote></blockquote><blockquote><p><b>Suspect Entity</b></p><blockquote><p><b>url</b></p><code>instance</code></blockquote><p><b>value</b>: <a href=\"MedicationAdministration-medication-administration-tucatinib.html\">MedicationAdministration/medication-administration-tucatinib</a></p><blockquote><p><b>url</b></p><code>causality</code></blockquote></blockquote><p><b>Expected In Research Study</b>: true</p><p><b>Note</b>: treatment held today per protocol guidelines and the patient was scheduled to return in one week for repeat lab work</p><blockquote><p><b>modifierExtension[http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status]</b></p></blockquote><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\"> (<a href=\"http://terminology.hl7.org/5.5.0/CodeSystem-mdr.html\">Medical Dictionary for Regulatory Activities</a>#10001551 &quot;Alanine aminotransferase increased&quot;)</span></p><p><b>subject</b>: <a href=\"Patient-patient-example-kaitlyn-b.html\">Patient/patient-example-kaitlyn-b</a> &quot; BOUNCE&quot;</p><p><b>date</b>: 2020-05-13</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> &quot; NURSE&quot;</p><p><b>study</b>: <a href=\"ResearchStudy-clinical-trial-example-compass.html\">ResearchStudy/clinical-trial-example-compass</a></p></div>"
      ] ; #
      fhir:extension ( [
    fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/resultingEffect"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:Reference ;
    fhir:display [ fhir:v "Reference to Observation of Alanine aminotransferase (ALT) increased at 200" ]     ]
      ] [
        ( fhir:extension [
    fhir:url [ fhir:v "item"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:Reference ;
    fhir:display [ fhir:v "Supporting info would have context such as an Reference to Observation of Alanine aminotransferase (ALT) increased at 200" ]       ]     ] ) ;
    fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/supporting-info"^^xsd:anyURI ]
      ] [
    fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-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 "C41340" ]       ] ) ;
    fhir:text [ fhir:v "Grade 3 Severe Adverse Event" ]     ]
      ] [
        ( fhir:extension [
    fhir:url [ fhir:v "function"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:CodeableConcept ;
            ( fhir:coding [
    fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/v3-ParticipationType"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "AUTHEN" ]         ] )       ]     ] [
    fhir:url [ fhir:v "actor"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:Reference ;
    fhir:reference [ fhir:v "Practitioner/practitioner-owen-oncologist" ]       ]     ] ) ;
    fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/participant"^^xsd:anyURI ]
      ] [
        ( fhir:extension [
    fhir:url [ fhir:v "instance"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:Reference ;
    fhir:reference [ fhir:v "MedicationAdministration/medication-administration-kadcyla" ]       ]     ] [
          ( fhir:extension [
    fhir:url [ fhir:v "entityRelatedness"^^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 "C53258" ] ;
    fhir:display [ fhir:v "Possibly Related" ]           ] )         ]       ] ) ;
    fhir:url [ fhir:v "causality"^^xsd:anyURI ]     ] ) ;
    fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity"^^xsd:anyURI ]
      ] [
        ( fhir:extension [
    fhir:url [ fhir:v "instance"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:Reference ;
    fhir:reference [ fhir:v "MedicationAdministration/medication-administration-tucatinib" ]       ]     ] [
          ( fhir:extension [
    fhir:url [ fhir:v "entityRelatedness"^^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 "C53258" ] ;
    fhir:display [ fhir:v "Possibly Related" ]           ] )         ]       ] ) ;
    fhir:url [ fhir:v "causality"^^xsd:anyURI ]     ] ) ;
    fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/suspect-entity"^^xsd:anyURI ]
      ] [
    fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/expected-in-research-study"^^xsd:anyURI ] ;
    fhir:value [ fhir:v "true"^^xsd:boolean ]
      ] [
    fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/note"^^xsd:anyURI ] ;
    fhir:value [
    a fhir:Annotation ;
    fhir:text [ fhir:v "treatment held today per protocol guidelines and the patient was scheduled to return in one week for repeat lab work" ]     ]
      ] ) ; #
      fhir:modifierExtension ( [
    fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status"^^xsd:anyURI ] ;
    fhir:value [ fhir:v "in-progress" ]
      ] ) ; #
      fhir:actuality [ fhir:v "actual"] ; #
      fhir:event [
        ( fhir:coding [
    fhir:system [ fhir:v "https://www.meddra.org"^^xsd:anyURI ] ;
    fhir:code [ fhir:v "10001551" ] ;
    fhir:display [ fhir:v "Alanine aminotransferase increased" ]     ] ) ;
    fhir:text [ fhir:v "Alanine aminotransferase (ALT) increased to 200" ]
      ] ; #
      fhir:subject [
    fhir:reference [ fhir:v "Patient/patient-example-kaitlyn-b" ]
      ] ; #
      fhir:date [ fhir:v "2020-05-13"^^xsd:date] ; #
      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:study ( [
    fhir:reference [ fhir:v "ResearchStudy/clinical-trial-example-compass" ]
      ] ) . #