Adverse Event Clinical Research R4 Backport
1.0.1 - STU1

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

## Example AdverseEvent: AdverseEventFromProcedureNotStudyDrug

Generated Narrative: AdverseEvent

Resource AdverseEvent "AdverseEventFromProcedureNotStudyDrug"

Profile: Adverse Event Clinical Research

Resulting Effect: Condition/AEModeratehives: Moderate hives

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 (Medical Dictionary for Regulatory Activities#10019211 "Hypersensitivity reaction")

subject: Patient/patient-slp " EXAMPLE"

date: 2021-01-15

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

severity: Moderate (AdverseEventSeverity#moderate)

outcome: Recovered/Resolved (NCI Thesaurus#C49498)

study: ResearchStudy/research-study-acme