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
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
Mitigating Action
url
item
value: study drug withdrawn (NCI Thesaurus#C49502 "DRUG WITHDRAWN")
Mitigating Action
url
item
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)