@prefix fhir: . @prefix owl: . @prefix rdfs: . @prefix sct: . @prefix xsd: . # - resource ------------------------------------------------------------------- a fhir:_AdverseEvent ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "adverse-event-device-death"] ; # fhir:meta [ fhir:profile ( [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/AdverseEvent-clinical-research"^^xsd:anyURI ; fhir:link ] ) ] ; # fhir:text [ fhir:status [ fhir:v "extensions" ] ; fhir:div "

Generated Narrative: AdverseEvent

Resource AdverseEvent "adverse-event-device-death"

Profile: Adverse Event Clinical Research

Adverse Event Grade: Grade 5 Death related to adverse event (NCI Thesaurus#C48275)

Criteria reviewed in determining serious adverse event

url

criterionCode

value: Results In Persistent Or Significant Disability (NCI Thesaurus#C11338)

url

criterionPresent

value: false

Criteria reviewed in determining serious adverse event

url

criterionCode

value: Requires Inpatient Hospitalization (NCI Thesaurus#C83052)

url

criterionPresent

value: false

Criteria reviewed in determining serious adverse event

url

criterionCode

value: Death Related to Adverse Event (NCI Thesaurus#C48275)

url

criterionPresent

value: true

Criteria reviewed in determining serious adverse event

url

criterionCode

value: Is Life Threatening (NCI Thesaurus#C84266)

url

criterionPresent

value: false

Criteria reviewed in determining serious adverse event

url

criterionCode

value: Congenital Anomaly or Birth Defect (NCI Thesaurus#C83117)

url

criterionPresent

value: false

Criteria reviewed in determining serious adverse event

url

criterionCode

value: Other Medically Important Condition (NCI Thesaurus#C82521)

url

criterionPresent

value: false

Criteria reviewed in determining serious adverse event

url

criterionCode

value: Required Intervention to Prevent Permanent Impairment/damage (NCI Thesaurus#C201939)

url

criterionPresent

value: false

Resulting Effect: : Condition with Deep puncture wound (disorder) - SNOMED CT code. Note this different than the AdverseEvent.code in this instance.

Participant

url

function

value: authenticator (ParticipationType#AUTHEN)

url

actor

value: Practitioner/practitioner-owen-oncologist " ONCOLOGIST"

Suspect Entity

url

instance

value: Device/device-infuser

url

causality

Suspect Entity

url

instance

value: MedicationAdministration/medication-administration-kadcyla1

url

causality

Expected In Research Study: false

Note: During infusion of kadcyla an infuser exploded, shrapnel from the explosion caused a fatal puncture wound.

modifierExtension[http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status]

actuality: actual

category: Device (AdverseEventCategory#device)

event: Patient death due to device explosion (SNOMED CT#370903006 "Patient death or serious disability associated with the use or function of a device in patient care, in which the device is used or functions other than as intended (event)")

subject: Patient/patient-example-kaitlyn-b1 " HAMMER"

date: 2020-05-20

seriousness: Serious (AdverseEventSeriousness#serious)

outcome: Fatal (NCI Thesaurus#C48275)

recorder: Practitioner/practitioner-oncology-nurse-jane " NURSE"

study: ResearchStudy/clinical-trial-example-compass

" ] ; # fhir:extension ( [ 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 "C48275" ] ] ) ; fhir:text [ fhir:v "Grade 5 Death related to adverse event" ] ] ] [ fhir:extension ( [ fhir:url [ fhir:v "criterionCode"^^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 "C11338" ] ; fhir:display [ fhir:v "Results In Persistent Or Significant Disability" ] ] ) ] ] [ fhir:url [ fhir:v "criterionPresent"^^xsd:anyURI ] ; fhir:value [ fhir:v "false"^^xsd:boolean ] ] ) ; fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"^^xsd:anyURI ] ] [ fhir:extension ( [ fhir:url [ fhir:v "criterionCode"^^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 "C83052" ] ; fhir:display [ fhir:v "Requires Inpatient Hospitalization" ] ] ) ] ] [ fhir:url [ fhir:v "criterionPresent"^^xsd:anyURI ] ; fhir:value [ fhir:v "false"^^xsd:boolean ] ] ) ; fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"^^xsd:anyURI ] ] [ fhir:extension ( [ fhir:url [ fhir:v "criterionCode"^^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 "C48275" ] ; fhir:display [ fhir:v "Death Related to Adverse Event" ] ] ) ] ] [ fhir:url [ fhir:v "criterionPresent"^^xsd:anyURI ] ; fhir:value [ fhir:v "true"^^xsd:boolean ] ] ) ; fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"^^xsd:anyURI ] ] [ fhir:extension ( [ fhir:url [ fhir:v "criterionCode"^^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 "C84266" ] ; fhir:display [ fhir:v "Is Life Threatening" ] ] ) ] ] [ fhir:url [ fhir:v "criterionPresent"^^xsd:anyURI ] ; fhir:value [ fhir:v "false"^^xsd:boolean ] ] ) ; fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"^^xsd:anyURI ] ] [ fhir:extension ( [ fhir:url [ fhir:v "criterionCode"^^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 "C83117" ] ; fhir:display [ fhir:v "Congenital Anomaly or Birth Defect" ] ] ) ] ] [ fhir:url [ fhir:v "criterionPresent"^^xsd:anyURI ] ; fhir:value [ fhir:v "false"^^xsd:boolean ] ] ) ; fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"^^xsd:anyURI ] ] [ fhir:extension ( [ fhir:url [ fhir:v "criterionCode"^^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 "C82521" ] ; fhir:display [ fhir:v "Other Medically Important Condition" ] ] ) ] ] [ fhir:url [ fhir:v "criterionPresent"^^xsd:anyURI ] ; fhir:value [ fhir:v "false"^^xsd:boolean ] ] ) ; fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"^^xsd:anyURI ] ] [ fhir:extension ( [ fhir:url [ fhir:v "criterionCode"^^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 "C201939" ] ; fhir:display [ fhir:v "Required Intervention to Prevent Permanent Impairment/damage" ] ] ) ] ] [ fhir:url [ fhir:v "criterionPresent"^^xsd:anyURI ] ; fhir:value [ fhir:v "false"^^xsd:boolean ] ] ) ; fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/seriousness-criteria"^^xsd:anyURI ] ] [ 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 "Condition with Deep puncture wound (disorder) - SNOMED CT code. Note this different than the AdverseEvent.code in this instance." ] ] ] [ 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:link ; 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:link ; fhir:reference [ fhir:v "Device/device-infuser" ] ] ] [ 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 "C53260" ] ; fhir:display [ fhir:v "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:link ; fhir:reference [ fhir:v "MedicationAdministration/medication-administration-kadcyla1" ] ] ] [ 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 "C53256" ] ; fhir:display [ fhir:v "Not 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 "false"^^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 "During infusion of kadcyla an infuser exploded, shrapnel from the explosion caused a fatal puncture wound." ] ] ] ) ; # fhir:modifierExtension ( [ fhir:url [ fhir:v "http://hl7.org/fhir/uv/ae-research-backport-ig/StructureDefinition/status"^^xsd:anyURI ] ; fhir:value [ fhir:v "completed" ] ] ) ; # fhir:actuality [ fhir:v "actual"] ; # fhir:category ( [ fhir:coding ( [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/adverse-event-category"^^xsd:anyURI ] ; fhir:code [ fhir:v "device" ] ; fhir:display [ fhir:v "Device" ] ] ) ] ) ; # fhir:event [ fhir:coding ( [ a sct:370903006 ; fhir:system [ fhir:v "http://snomed.info/sct"^^xsd:anyURI ] ; fhir:code [ fhir:v "370903006" ] ; fhir:display [ fhir:v "Patient death or serious disability associated with the use or function of a device in patient care, in which the device is used or functions other than as intended (event)" ] ] ) ; fhir:text [ fhir:v "Patient death due to device explosion" ] ] ; # fhir:subject [ fhir:link ; fhir:reference [ fhir:v "Patient/patient-example-kaitlyn-b1" ] ] ; # fhir:date [ fhir:v "2020-05-20"^^xsd:date] ; # fhir:seriousness [ fhir:coding ( [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/adverse-event-seriousness"^^xsd:anyURI ] ; fhir:code [ fhir:v "serious" ] ; fhir:display [ fhir:v "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 "C48275" ] ] ) ; fhir:text [ fhir:v "Fatal" ] ] ; # fhir:recorder [ fhir:link ; fhir:reference [ fhir:v "Practitioner/practitioner-oncology-nurse-jane" ] ] ; # fhir:study ( [ fhir:link ; fhir:reference [ fhir:v "ResearchStudy/clinical-trial-example-compass" ] ] ) . # a fhir:uv . a fhir:uv . a fhir:uv . a fhir:uv . a fhir:uv . a fhir:uv . # -------------------------------------------------------------------------------------