Generated Narrative: AdverseEvent

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

status: completed

actuality: actual

category: Device (AdverseEventCategory#device)

code: 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"

occurrence: 2020-05-20 --> (ongoing)

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

seriousness: Serious (AdverseEventSeriousness#serious)

outcome: Fatal (NCI Thesaurus#C48275)

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

Participants

study: ResearchStudy/clinical-trial-example-compass

expectedInResearchStudy: false

suspectEntity

instance: Device/device-infuser

Causalities

-	EntityRelatedness
*	Related (NCI Thesaurus#C53260)

suspectEntity

instance: MedicationAdministration/medication-administration-kadcyla1

Causalities

-	EntityRelatedness
*	Not Related (NCI Thesaurus#C53256)

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