Adverse Event Clinical Research
1.0.1 - STU1

Adverse Event Clinical Research, 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-ig/ and changes regularly. See the Directory of published versions

## Example AdverseEvent: AdverseEventFromProcedureNotStudyDrug

Page standards status: Informative

Generated Narrative: AdverseEvent

Resource AdverseEvent "AdverseEventFromProcedureNotStudyDrug"

Profile: Adverse Event Clinical Research

Adverse Event Severity: Moderate (AdverseEventSeverity#moderate)

Adverse event caused subject to discontinue the study: false

status: completed

actuality: actual

code: Moderate hives (Medical Dictionary for Regulatory Activities#10019211 "Hypersensitivity reaction")

subject: Patient/patient-slp " EXAMPLE"

occurrence: 2021-01-15 --> 2021-01-15

resultingEffect: Condition/AEModeratehives: Moderate hives

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

outcome: Recovered/Resolved (NCI Thesaurus#C49498)

study: ResearchStudy/research-study-acme

expectedInResearchStudy: false

> suspectEntity

> instance: MedicationAdministration/study-medication-administration-WBY

> ### Causalities

> - | EntityRelatedness
> * | Unlikely Related (NCI Thesaurus#C53257)

> suspectEntity

> instance: MedicationAdministration/medication-administration-contrast-dye

> ### Causalities

> - | EntityRelatedness
> * | Related (NCI Thesaurus#C53260)

### ContributingFactors

- | Item[x]
* | Procedure/clinical-trial-acme-procedure

### MitigatingActions

- | Item[x]
* | MedicationAdministration/medication-administration-forhives

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