Adverse Event Clinical Research
1.0.0-ballot - ballot International flag

This page is part of the Adverse Event Clinical Research (v1.0.0-ballot: STU 1 Ballot 1) based on FHIR v5.0.0. . For a full list of available versions, see the Directory of published versions

Example AdverseEvent: ClinicalResearchAdverseEventUseCase16

Page standards status: Informative

Generated Narrative: AdverseEvent

Resource AdverseEvent "ClinicalResearchAdverseEventUseCase16"

Profile: Adverse Event Clinical Research

Severity Or Grade: Mild (AdverseEvent Severity or Grade Codes#1)

Adverse event caused subject to discontinue the study: false

status: completed

actuality: actual

code: Headache (www.meddra.org#10019211)

subject: Patient/patient-moumic " EXAMPLE"

occurrence: 2022-02-01 --> (ongoing)

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

outcome: Not recovering/not resolved (NCI Thesaurus#C49494)

study: ResearchStudy/research-study-DISNEY

expectedInResearchStudy: true

suspectEntity

instance: MedicationAdministration/study-medication-administration-MMD

Causalities

-EntityRelatedness
*Unlikely Related (NCI Thesaurus#C53257)

MitigatingActions

-Item[x]
*MedicationAdministration/medication-administration-tylenol

note: Headaches are mild, occur once a week and resolved with Tylenol, but still ongoing. Action taken with the study is dose not changed.