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

## Example AdverseEvent: adverse-event-device-death

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