Adverse Event Clinical Research R4 Backport
1.0.1 - STU1 International flag

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value: study drug withdrawn (NCI Thesaurus#C49502 "DRUG WITHDRAWN")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