Generated Narrative: AdverseEvent

Severity Or Grade: Severe (AdverseEvent Severity or Grade Codes#3)

Resulting Effect: Condition/GIBleedUseCase15

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: resultsInPersistentOrSignificantDisability (NCI Thesaurus#C11338)

url

criterionPresent

value: false

Criteria reviewed in determining serious adverse event

url

criterionCode

value: requiresInpatientHospitalization (NCI Thesaurus#C83052)

url

criterionPresent

value: true

Criteria reviewed in determining serious adverse event

url

criterionCode

value: resultsInDeath (NCI Thesaurus#C48275)

url

criterionPresent

value: false

Criteria reviewed in determining serious adverse event

url

criterionCode

value: isLifeThreatening (NCI Thesaurus#C84266)

url

criterionPresent

value: true

Criteria reviewed in determining serious adverse event

url

criterionCode

value: congenitalAnomalyBirthDefect (NCI Thesaurus#C83117)

url

criterionPresent

value: false

Criteria reviewed in determining serious adverse event

url

criterionCode

value: otherMedicallyImportantCondition (NCI Thesaurus#C82521)

url

criterionPresent

value: false

Criteria reviewed in determining serious adverse event

url

criterionCode

value: Required Intervention to Prevent Permanent Impairment or Damage (Devices) (FDA Additional Seriousness Criteria CodeSystem#requiresPreventImpairment)

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value: study drug withdrawn (NCI Thesaurus#C49502 "DRUG WITHDRAWN")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 (www.meddra.org#10017955)

subject: Patient/SCHJO ""

date: 2021-12-02

seriousness: Serious (AdverseEventSeriousness#serious)

outcome: C49498"Recovered/Resolved" (NCI Thesaurus#C49498"Recovered/Resolved")

study: ResearchStudy/research-study-XYZ