Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 Ballot 3 World

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-ballot3 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

Evidence: Percentage of Participants With Serious Adverse Events (SAEs) at 12 weeks for QUARTET LDQT in NCT03640312

Official URL: https://fevir.net/resources/Evidence/367927 Version: 1.0.0-ballot3
Standards status: Informative Computable Name: NCT03640312_otherOutcomeMeasure_0_OG000
Other Identifiers: FEvIR Object Identifier: FEvIR Object Identifier#367927, FEvIR Linking Identifier: NCT03640312-otherOutcomeMeasure-0--OG000, OID:2.16.840.1.113883.4.642.40.44.22.247

Copyright/Legal: Copyright the Authors else Computable Publishing LLC. Noncommercial use permitted with CC BY-NC-SA 4.0 (https://creativecommons.org/licenses/by-nc-sa/4.0/). Commercial use permitted as agreed in Terms of Use (https://fevir.net/termsofuse).

This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.

version: 30; Last updated: 2026-09-08 12:21:25+0000

Profile: NonComparativeEvidence

ArtifactPublicationStatus: Active

url: Evidence Percentage of Participants With Serious Adverse Events (SAEs) at 12 weeks for QUARTET LDQT in NCT03640312

identifier: FEvIR Object Identifier/367927, FEvIR Linking Identifier/NCT03640312-otherOutcomeMeasure-0--OG000, Uniform Resource Identifier (URI)/urn:oid:2.16.840.1.113883.4.642.40.44.22.247

version: 1.0.0-ballot3

name: NCT03640312_otherOutcomeMeasure_0_OG000

title: Percentage of Participants With Serious Adverse Events (SAEs) at 12 weeks for QUARTET LDQT in NCT03640312

citeAs:

Percentage of Participants With Serious Adverse Events (SAEs) at 12 weeks for QUARTET LDQT in NCT03640312 [Database Entry: FHIR Evidence Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 367927. Revised 2026-09-08. Available at: https://fevir.net/resources/Evidence/367927. Computable resource at: https://fevir.net/resources/Evidence/367927#json.

status: Active

date: 2026-11-05 14:34:28+0000

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

publisher: HL7 International / Clinical Decision Support

contact: HL7 International / Clinical Decision Support: http://www.hl7.org/Special/committees/dss

copyright:

Copyright the Authors else Computable Publishing LLC. Noncommercial use permitted with CC BY-NC-SA 4.0 (https://creativecommons.org/licenses/by-nc-sa/4.0/). Commercial use permitted as agreed in Terms of Use (https://fevir.net/termsofuse).

description:

This Evidence Resource is referenced in an example for the EBMonFHIR Implementation Guide.

variableDefinition

description:

QUARTET LDQT

note: ,

Outcome Measure Population Description: All randomized participants

Outcome Measure Denominator Units: Participants

variableRole: Population

observed: Patients randomized to the intervention arm took a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. (Identifier: ClinicalTrials.gov Outcome Measurement Group Id/OG000)

variableDefinition

variableRole: Outcome

observed: Percentage of Participants With Serious Adverse Events (SAEs) at 12 weeks - (NCT03640312)

statistic

statisticType: risk

quantity: 6.25 %

numberAffected: 2

SampleSizes

-KnownDataCount
*32