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: SeriousAdverseEventResearchStudy

Generated Narrative: AdverseEvent

Resource AdverseEvent "SeriousAdverseEventResearchStudy"

Profile: Adverse Event Clinical Research

Resulting Effect: Condition/GIBleed

> Suspect Entity

> > url

> > `instance`

> value: MedicationAdministration/study-medication-administration-ABC

> > url

> > `causality`

Adverse Event resolution date: 2021-12-09

> 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: true

> Criteria reviewed in determining serious adverse event

> > url

> > `criterionCode`

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

> > url

> > `criterionPresent`

> value: false

> Criteria reviewed in determining serious adverse event

> > url

> > `criterionCode`

> value: Is Life Threatening (NCI Thesaurus#C84266)

> > url

> > `criterionPresent`

> value: true

> 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: true

> Mitigating Action

> > url

> > `item`

> value: Procedure/procedure-upper-endoscopy

> Mitigating Action

> > url

> > `item`

> value: study drug withdrawn (NCI Thesaurus#C49502 "DRUG WITHDRAWN")

> Mitigating Action

> > url

> > `item`

> value: MedicationRequest/medicationrequest-for-study-medication-administration-ABC: Medication Request where study drug prescription was discontinued

Adverse event caused subject to discontinue the study: true

Expected In Research Study: false

> Supporting information relevant to the event

> > url

> > `item`

> value: : Supporting info would have context such as an Observation on the drop in hemoglobin

Note: The patient’s hemoglobin dropped to 6.5 g/dL and received 2 units of PRBCs. The patient had an upper endoscopy that showed a moderate amount of bleeding from the esophagus. The site was cauterized, and the patient had no further bleeding after the procedure. The GI bleed resolved within one week after discontinuation of study drug and the patient was discharged on 9-Dec-2021 in good condition.

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

actuality: actual

event: Gastrointestinal haemorrhage (Medical Dictionary for Regulatory Activities#10017955)

subject: Patient/SCHJO ""

date: 2021-12-02

seriousness: Serious (AdverseEventSeriousness#serious)

severity: Severe (AdverseEventSeverity#severe)

outcome: Recovered/Resolved (NCI Thesaurus#C49498)

study: ResearchStudy/research-study-XYZ