Adverse Event Clinical Research R4 Backport
1.0.0-ballot - ballot International flag

This page is part of the Adverse Event Clinical Research R4 Backport (v1.0.0-ballot: STU 1 Ballot 1) based on FHIR R4. . For a full list of available versions, see the Directory of published versions

Example AdverseEvent: ClinicalResearchAdverseEventUseCase17

Generated Narrative: AdverseEvent

Resource AdverseEvent "ClinicalResearchAdverseEventUseCase17"

Profile: Adverse Event Clinical Research

Severity Or Grade: Moderate (AdverseEvent Severity or Grade Codes#2)

Adverse Event resolution date: 2021-01-15

Suspect Entity

url

instance

value: MedicationAdministration/study-medication-administration-WBY

url

causality

Suspect Entity

url

instance

value: MedicationAdministration/medication-administration-contrast-dye

url

causality

Expected In Research Study: false

Note: The action taken with the study treatment was the study drug dose not changed

Adverse event caused subject to discontinue the study: false

Mitigating Action

url

item

value: MedicationAdministration/medication-administration-forhives

Contributing Factor

url

item

value: Procedure/clinical-trial-acme-procedure

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

actuality: actual

event: Moderate hives (NCI Thesaurus#C57954 "Grade 2 - Urticaria")

subject: Patient/patient-slp " EXAMPLE"

date: 2021-01-15

seriousness: Non-serious (AdverseEventSeriousness#non-serious)

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

study: ResearchStudy/research-study-acme