Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot International flag

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

Example EvidenceVariable: Percentage of Participants With Serious Adverse Events (SAEs) (NCT03640312)

version: 25; Last updated: 2025-08-15 10:32:26+0000

Profile: VariableDefinition

EvidenceVariableHandlingDetail: Evidence variable handling not specified

url: https://fevir.net/resources/EvidenceVariable/367896

identifier: FEvIR Object Identifier/367896, FEvIR Linking Identifier/NCT03640312-otherOutcome-0

name: Percentage_of_Participants_With_Serious_Adverse_Events_SAEs_NCT03640312

title: Percentage of Participants With Serious Adverse Events (SAEs) (NCT03640312)

citeAs:

Percentage of Participants With Serious Adverse Events (SAEs) (NCT03640312) [Database Entry: FHIR EvidenceVariable Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 367896. Revised 2025-08-15. Available at: https://fevir.net/resources/EvidenceVariable/367896. Computable resource at: https://fevir.net/resources/EvidenceVariable/367896#json.

status: Active

author: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter:

publisher: Computable Publishing LLC

contact: support@computablepublishing.com

description:

Percentage of participants with any Serious Adverse Events (SAE) according to Good Clinical Practice definition: adverse events that result in death, are life threatening, require hospitalization or prolong existing hospitalization, result in persistent disability, result in congenital anomaly or birth defect, or unimportant medical event that requires intervention to prevent any of the above.

copyright:

https://creativecommons.org/licenses/by-nc-sa/4.0/

Definitions

-Reference
*Group: membership = conceptual

handling: extension

Generated Narrative: Group #variable-definition

membership: Conceptual

characteristic

code: defined by CodeableConcept

value: Percentage of Participants With Serious Adverse Events (SAEs)

exclude: false

Timings

-Text
*12 weeks