Adverse Event Clinical Research
1.0.1 - STU1 International flag

This page is part of the Adverse Event Clinical Research (v1.0.1: STU 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions

Example AdverseEvent: SeriousAdverseEventResearchStudy

Page standards status: Informative

Generated Narrative: AdverseEvent

Resource AdverseEvent "SeriousAdverseEventResearchStudy"

Profile: Adverse Event Clinical Research

Adverse Event Severity: Severe (AdverseEventSeverity#severe)

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

Adverse event caused subject to discontinue the study: true

status: completed

actuality: actual

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

subject: Patient/SCHJO ""

occurrence: 2021-12-02 --> 2021-12-09

resultingEffect: Condition/GIBleed

seriousness: Serious (AdverseEventSeriousness#serious)

outcome: Recovered/Resolved (NCI Thesaurus#C49498)

study: ResearchStudy/research-study-XYZ

expectedInResearchStudy: false

suspectEntity

instance: MedicationAdministration/study-medication-administration-ABC

Causalities

-EntityRelatedness
*Possibly Related (NCI Thesaurus#C53258)

mitigatingAction

item: Procedure/procedure-upper-endoscopy

mitigatingAction

item: study drug withdrawn (NCI Thesaurus#C49502 "DRUG WITHDRAWN")

mitigatingAction

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

SupportingInfos

-Item[x]
*: 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.