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 in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Example AdverseEvent: NonSeriousAdverseEventResearchStudyMed

Page standards status: Informative

Generated Narrative: AdverseEvent

Resource AdverseEvent "NonSeriousAdverseEventResearchStudyMed"

Profile: Adverse Event Clinical Research

Adverse Event Severity: Mild (AdverseEventSeverity#mild)

Adverse event caused subject to discontinue the study: false

status: completed

actuality: actual

code: Headache (Medical Dictionary for Regulatory Activities#10019211)

subject: Patient/patient-moumic " EXAMPLE"

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

resultingEffect: Condition/AEHeadache: Mild Headache

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.