http://hl7.org/fhir/uv/ebm/Composition/370504
type: Composition
node role: treeRoot
id:
  v: 370504
meta:
  version id:
    v: 24
  last updated:
    v: 2025-08-18T13:22:42.074Z
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/outcome-measure-report
    l: outcome-measure-report
language:
  v: en
text:
  status:
    v: extensions
  div:
    v: Generated Narrative: Composition 370504 version: 24; Last updated: 2025-08-18 13:22:42+0000; Language: en Profile: OutcomeMeasureReport ArtifactPublicationStatus: Active url: https://fevir.net/resources/Composition/370504 identifier: FEvIR Object Identifier/370504, FEvIR Linking Identifier/NCT03640312-outcome-measure-report status: Final type: Outcome Measure Report date: 2025-08-18 13:22:42+0000 author: [No author listed.] title: Outcome Measures Report for NCT03640312 custodian: Computable Publishing LLC RelatesTos - Type Target[x] * Cite As Outcome Measures Report for NCT03640312 [Database Entry: FHIR Composition Resource]. Contributors: [No author listed.] [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 370504. Revised 2025-08-18. Available at: https://fevir.net/resources/Composition/370504. Computable resource at: https://fevir.net/resources/Composition/370504.
extension:
  url:
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    l: artifact-publication-status
  value: CodeableConcept
    coding:
      system:
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        l: cited-artifact-status-type
      code:
        v: active
      display:
        v: Active
url:
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  l: https://fevir.net/resources/Composition/370504
identifier:
  type:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/v2-0203
        l: v2-0203
      code:
        v: ACSN
      display:
        v: Accession ID
    text:
      v: FEvIR Object Identifier
  system:
    v: https://fevir.net/FOI
    l: FOI
  value:
    v: 370504
  assigner:
    display:
      v: Computable Publishing LLC
identifier:
  type:
    text:
      v: FEvIR Linking Identifier
  system:
    v: https://fevir.net/FLI
    l: FLI
  value:
    v: NCT03640312-outcome-measure-report
  assigner:
    display:
      v: Computable Publishing LLC
status:
  v: final
type:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: OutcomeMeasureReport
    display:
      v: OutcomeMeasureReport
  text:
    v: Outcome Measure Report
date:
  v: 2025-08-18T13:22:42.074Z
author:
  display:
    v: [No author listed.]
title:
  v: Outcome Measures Report for NCT03640312
custodian:
  l: http://hl7.org/fhir/uv/ebm/Organization/118079
  reference:
    v: Organization/118079
  type:
    v: Organization
    l: Organization
  display:
    v: Computable Publishing LLC
relates to:
  type:
    v: cite-as
  target: Markdown
    v: Outcome Measures Report for NCT03640312 [Database Entry: FHIR Composition Resource]. Contributors: [No author listed.] [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 370504. Revised 2025-08-18. Available at: https://fevir.net/resources/Composition/370504. Computable resource at: https://fevir.net/resources/Composition/370504.
section:
  title:
    v: Change in Mean Systolic Blood Pressure at 12 weeks
  focus:
    l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/367882
    reference:
      v: EvidenceVariable/367882
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    identifier:
      system:
        v: https://fevir.net/FLI
        l: FLI
      value:
        v: NCT03640312-primaryOutcome-0
    display:
      v: Change in Mean Systolic Blood Pressure at 12 weeks (NCT03640312)
  section:
    title:
      v: Outcome Measure Population Description
    code:
      text:
        v: OutcomeMeasurePopulationDescription
    text:
      status:
        v: generated
      div:
        v: Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.
  section:
    title:
      v: Outcome Measure Reporting Status
    code:
      text:
        v: OutcomeMeasureReportingStatus
    text:
      status:
        v: generated
      div:
        v: Posted
  section:
    title:
      v: Outcome Measure Time Frame
    code:
      text:
        v: OutcomeMeasureTimeFrame
    text:
      status:
        v: generated
      div:
        v: 12 weeks
  section:
    title:
      v: Outcome Group List
    code:
      text:
        v: OutcomeGroupList
    section:
      title:
        v: QUARTET LDQT
    section:
      title:
        v: Candesartan
  section:
    title:
      v: Outcome Class List
    code:
      text:
        v: OutcomeClassList
    section:
      title:
        v: Change in Mean Systolic Blood Pressure at 12 weeks (NCT03640312)
      focus:
        l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/367882
      entry:
        l: http://hl7.org/fhir/uv/ebm/Evidence/367903
      entry:
        l: http://hl7.org/fhir/uv/ebm/Evidence/367904
      entry:
        l: http://hl7.org/fhir/uv/ebm/Evidence/367941
section:
  title:
    v: Mean Systolic Blood Pressure at 6 weeks
  focus:
    l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/367883
    reference:
      v: EvidenceVariable/367883
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    identifier:
      system:
        v: https://fevir.net/FLI
        l: FLI
      value:
        v: NCT03640312-secondaryOutcome-0
    display:
      v: Mean Systolic Blood Pressure at 6 weeks (NCT03640312)
  section:
    title:
      v: Outcome Measure Population Description

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: OG000

v: generated

v: 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.

v: 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.

v: OG001

v: generated

v: Patients randomized to the comparison arm took a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.

v: Patients randomized to the comparison arm took a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.

system:
  v: https://fevir.net/resources/CodeSystem/179423
  l: https://fevir.net/resources/CodeSystem/179423
code:
  v: results
display:
  v: Results

v: EvidenceVariable/367882

v: EvidenceVariable
l: EvidenceVariable

type:
  text:
    v: FEvIR Linking Identifier
system:
  v: https://fevir.net/FLI
  l: FLI
value:
  v: NCT03640312-primaryOutcome-0
assigner:
  display:
    v: Computable Publishing LLC

v: Change in Mean Systolic Blood Pressure at 12 weeks (NCT03640312)

v: Evidence/367903

v: Evidence
l: Evidence

type:
  text:
    v: FEvIR Linking Identifier
system:
  v: https://fevir.net/FLI
  l: FLI
value:
  v: NCT03640312-primaryOutcomeMeasure-0--OG000
assigner:
  display:
    v: Computable Publishing LLC

v: Change in Mean Systolic Blood Pressure at 12 weeks for QUARTET LDQT in NCT03640312

v: Evidence/367904

v: Evidence
l: Evidence

type:
  text:
    v: FEvIR Linking Identifier
system:
  v: https://fevir.net/FLI
  l: FLI
value:
  v: NCT03640312-primaryOutcomeMeasure-0--OG001
assigner:
  display:
    v: Computable Publishing LLC

v: Change in Mean Systolic Blood Pressure at 12 weeks for Candesartan in NCT03640312

v: Evidence/367941

v: Evidence
l: Evidence

type:
  text:
    v: FEvIR Linking Identifier
system:
  v: https://fevir.net/FLI
  l: FLI
value:
  v: NCT03640312-primaryOutcomeMeasure-0-OutcomeAnalysis-0-BetweenGroupAnalysis-OG000-OG001
assigner:
  display:
    v: Computable Publishing LLC

v: Change in Mean Systolic Blood Pressure at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312

v: FEvIR Linking Identifier

v: Computable Publishing LLC

text:
  v: OutcomeMeasurePopulationDescription

status:
  v: generated
div:
  v: Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.

title:
  v: Outcome Measure Reporting Status
code:
  text:
    v: OutcomeMeasureReportingStatus
text:
  status:
    v: generated
  div:
    v: Posted

title:
  v: Outcome Measure Time Frame
code:
  text:
    v: OutcomeMeasureTimeFrame
text:
  status:
    v: generated
  div:
    v: 6 weeks

title:
  v: Outcome Group List
code:
  text:
    v: OutcomeGroupList
section:
  title:
    v: QUARTET LDQT
  code:
    text:
      v: OG000
  text:
    status:
      v: generated
    div:
      v: 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.
  entry:
    display:
      v: 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.
section:
  title:
    v: Candesartan
  code:
    text:
      v: OG001
  text:
    status:
      v: generated
    div:
      v: Patients randomized to the comparison arm took a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
  entry:
    display:
      v: Patients randomized to the comparison arm took a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.

title:
  v: Outcome Class List
code:
  text:
    v: OutcomeClassList
section:
  title:
    v: Mean Systolic Blood Pressure at 6 weeks (NCT03640312)
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: results
      display:
        v: Results
  focus:
    l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/367883
    reference:
      v: EvidenceVariable/367883
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    identifier:
      system:
        v: https://fevir.net/FLI
        l: FLI
      value:
        v: NCT03640312-secondaryOutcome-0
    display:
      v: Mean Systolic Blood Pressure at 6 weeks (NCT03640312)
  entry:
    l: http://hl7.org/fhir/uv/ebm/Evidence/367905
    reference:
      v: Evidence/367905
    type:
      v: Evidence
      l: Evidence
    identifier:
      system:
        v: https://fevir.net/FLI
        l: FLI
      value:
        v: NCT03640312-secondaryOutcomeMeasure-0--OG000
    display:
      v: Mean Systolic Blood Pressure at 6 weeks for QUARTET LDQT in NCT03640312
  entry:
    l: http://hl7.org/fhir/uv/ebm/Evidence/367906
    reference:
      v: Evidence/367906
    type:
      v: Evidence
      l: Evidence
    identifier:
      system:
        v: https://fevir.net/FLI
        l: FLI
      value:
        v: NCT03640312-secondaryOutcomeMeasure-0--OG001
    display:
      v: Mean Systolic Blood Pressure at 6 weeks for Candesartan in NCT03640312
  entry:
    l: http://hl7.org/fhir/uv/ebm/Evidence/367942
    reference:
      v: Evidence/367942
    type:
      v: Evidence
      l: Evidence
    identifier:
      system:
        v: https://fevir.net/FLI
        l: FLI
      value:
        v: NCT03640312-secondaryOutcomeMeasure-0-OutcomeAnalysis-1-BetweenGroupAnalysis-OG000-OG001
    display:
      v: Mean Systolic Blood Pressure at 6 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

v: FEvIR Linking Identifier

v: Computable Publishing LLC

title:
  v: Change in Mean Diastolic Blood Pressure at 6 weeks
focus:
  l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/367884
  reference:
    v: EvidenceVariable/367884
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  identifier:
    type:
      text:
        v: FEvIR Linking Identifier
    system:
      v: https://fevir.net/FLI
      l: FLI
    value:
      v: NCT03640312-secondaryOutcome-1
    assigner:
      display:
        v: Computable Publishing LLC
  display:
    v: Change in Mean Diastolic Blood Pressure at 6 weeks (NCT03640312)
section:
  title:
    v: Outcome Measure Population Description
  code:
    text:
      v: OutcomeMeasurePopulationDescription
  text:
    status:
      v: generated
    div:
      v: Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.
section:
  title:
    v: Outcome Measure Reporting Status
  code:
    text:
      v: OutcomeMeasureReportingStatus
  text:
    status:
      v: generated
    div:
      v: Posted
section:
  title:
    v: Outcome Measure Time Frame
  code:
    text:
      v: OutcomeMeasureTimeFrame
  text:
    status:
      v: generated
    div:
      v: 6 weeks
section:
  title:
    v: Outcome Group List
  code:
    text:
      v: OutcomeGroupList
  section:
    title:
      v: QUARTET LDQT
    code:
      text:
        v: OG000
    text:
      status:
        v: generated
      div:
        v: 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.
    entry:
      display:
        v: 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.
  section:
    title:
      v: Candesartan
    code:
      text:
        v: OG001
    text:
      status:
        v: generated
      div:
        v: Patients randomized to the comparison arm took a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
    entry:
      display:
        v: Patients randomized to the comparison arm took a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
section:
  title:
    v: Outcome Class List
  code:
    text:
      v: OutcomeClassList
  section:
    title:
      v: Change in Mean Diastolic Blood Pressure at 6 weeks (NCT03640312)
    focus:
      l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/367884
      reference:
        v: EvidenceVariable/367884
      type:
        v: EvidenceVariable
        l: EvidenceVariable
      display:
        v: Change in Mean Diastolic Blood Pressure at 6 weeks (NCT03640312)
    entry:
      l: http://hl7.org/fhir/uv/ebm/Evidence/367907
      reference:
        v: Evidence/367907
      type:
        v: Evidence
        l: Evidence
      display:
        v: Change in Mean Diastolic Blood Pressure at 6 weeks for QUARTET LDQT in NCT03640312
    entry:
      l: http://hl7.org/fhir/uv/ebm/Evidence/367908
      reference:
        v: Evidence/367908
      type:
        v: Evidence
        l: Evidence
      display:
        v: Change in Mean Diastolic Blood Pressure at 6 weeks for Candesartan in NCT03640312
    entry:
      l: http://hl7.org/fhir/uv/ebm/Evidence/367943
      reference:
        v: Evidence/367943
      type:
        v: Evidence
        l: Evidence
      display:
        v: Change in Mean Diastolic Blood Pressure at 6 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312

v: results

v: Results

text:
  v: FEvIR Linking Identifier

v: NCT03640312-secondaryOutcome-1

display:
  v: Computable Publishing LLC

text:
  v: FEvIR Linking Identifier

v: NCT03640312-secondaryOutcomeMeasure-1--OG000

display:
  v: Computable Publishing LLC

text:
  v: FEvIR Linking Identifier

v: NCT03640312-secondaryOutcomeMeasure-1--OG001

display:
  v: Computable Publishing LLC

text:
  v: FEvIR Linking Identifier

v: NCT03640312-secondaryOutcomeMeasure-1-OutcomeAnalysis-2-BetweenGroupAnalysis-OG000-OG001

display:
  v: Computable Publishing LLC

title:
  v: Mean Diastolic Blood Pressure at 6 weeks
focus:
  l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/367885
  reference:
    v: EvidenceVariable/367885
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  identifier:
    type:
      text:
        v: FEvIR Linking Identifier
    system:
      v: https://fevir.net/FLI
      l: FLI
    value:
      v: NCT03640312-secondaryOutcome-2
    assigner:
      display:
        v: Computable Publishing LLC
  display:
    v: Mean Diastolic Blood Pressure at 6 weeks (NCT03640312)
section:
  title:
    v: Outcome Measure Population Description
  code:
    text:
      v: OutcomeMeasurePopulationDescription
  text:
    status:
      v: generated
    div:
      v: Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.
section:
  title:
    v: Outcome Measure Reporting Status
  code:
    text:
      v: OutcomeMeasureReportingStatus
  text:
    status:
      v: generated
    div:
      v: Posted
section:
  title:
    v: Outcome Measure Time Frame
  code:
    text:
      v: OutcomeMeasureTimeFrame
  text:
    status:
      v: generated
    div:
      v: 6 weeks
section:
  title:
    v: Outcome Group List
  code:
    text:
      v: OutcomeGroupList
  section:
    title:
      v: QUARTET LDQT
    code:
      text:
        v: OG000
    text:
      status:
        v: generated
      div:
        v: 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.
    entry:
      display:
        v: 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.
  section:
    title:
      v: Candesartan
    code:
      text:
        v: OG001
    text:
      status:
        v: generated
      div:
        v: Patients randomized to the comparison arm took a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
    entry:
      display:
        v: Patients randomized to the comparison arm took a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
section:
  title:
    v: Outcome Class List
  code:
    text:
      v: OutcomeClassList
  section:
    title:
      v: Mean Diastolic Blood Pressure at 6 weeks (NCT03640312)
    focus:
      l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/367885
      reference:
        v: EvidenceVariable/367885
      type:
        v: EvidenceVariable
        l: EvidenceVariable
      display:
        v: Mean Diastolic Blood Pressure at 6 weeks (NCT03640312)
    entry:
      l: http://hl7.org/fhir/uv/ebm/Evidence/367909
      reference:
        v: Evidence/367909
      type:
        v: Evidence
        l: Evidence
      display:
        v: Mean Diastolic Blood Pressure at 6 weeks for QUARTET LDQT in NCT03640312
    entry:
      l: http://hl7.org/fhir/uv/ebm/Evidence/367910
      reference:
        v: Evidence/367910
      type:
        v: Evidence
        l: Evidence
      display:
        v: Mean Diastolic Blood Pressure at 6 weeks for Candesartan in NCT03640312
    entry:
      l: http://hl7.org/fhir/uv/ebm/Evidence/367944
      reference:
        v: Evidence/367944
      type:
        v: Evidence
        l: Evidence
      display:
        v: Mean Diastolic Blood Pressure at 6 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312

v: results

v: Results

text:
  v: FEvIR Linking Identifier

v: NCT03640312-secondaryOutcome-2

display:
  v: Computable Publishing LLC

text:
  v: FEvIR Linking Identifier

v: NCT03640312-secondaryOutcomeMeasure-2--OG000

display:
  v: Computable Publishing LLC

text:
  v: FEvIR Linking Identifier

v: NCT03640312-secondaryOutcomeMeasure-2--OG001

display:
  v: Computable Publishing LLC

text:
  v: FEvIR Linking Identifier

v: NCT03640312-secondaryOutcomeMeasure-2-OutcomeAnalysis-3-BetweenGroupAnalysis-OG000-OG001

display:
  v: Computable Publishing LLC

title:
  v: Proportion of Patients With Hypertension Control at 6 and 12 weeks
focus:
  l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/367886
  reference:
    v: EvidenceVariable/367886
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  identifier:
    type:
      text:
        v: FEvIR Linking Identifier
    system:
      v: https://fevir.net/FLI
      l: FLI
    value:
      v: NCT03640312-secondaryOutcome-3
    assigner:
      display:
        v: Computable Publishing LLC
  display:
    v: Proportion of Patients With Hypertension Control at 6 and 12 weeks (NCT03640312)
section:
  title:
    v: Outcome Measure Population Description
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v: Results

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v: FEvIR Linking Identifier

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        v: Number of Patients Requiring Step up Treatment at 6 weeks for Candesartan in NCT03640312
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  v: FEvIR Linking Identifier

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  v: FEvIR Linking Identifier

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title:
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      v: Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.
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  v: FEvIR Linking Identifier

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  v: FEvIR Linking Identifier

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      v: Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.
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      v: Data are available on only 28 participants in the intervention group for the mental health T score.
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        v: Health-related Quality of Life at 12 weeks - Change in Mental Health T score (PROMIS) for QUARTET LDQT in NCT03640312
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        l: Evidence
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        v: Health-related Quality of Life at 12 weeks - Change in Mental Health T score (PROMIS) for Candesartan in NCT03640312
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v: Results

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v: NCT03640312-secondaryOutcome-7-Change-in-Physical-Health-T-score--OPEN---PROMIS---CLOSE--

display:
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v: Results

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display:
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assigner:
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v: Health-related Quality of Life at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312

title:
  v: Change in Mean Systolic Blood Pressure at 6 weeks
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    v: EvidenceVariable/367891
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    type:
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        v: FEvIR Linking Identifier
    system:
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      v: Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.
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      v: OutcomeMeasureReportingStatus
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    v: Outcome Measure Time Frame
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      v: OutcomeMeasureTimeFrame
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        v: 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.
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        v: Patients randomized to the comparison arm took a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
    entry:
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        v: Patients randomized to the comparison arm took a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
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  section:
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        l: Evidence
      display:
        v: Change in Mean Systolic Blood Pressure at 6 weeks for QUARTET LDQT in NCT03640312
    entry:
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        v: Evidence
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      display:
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v: results

v: Results

text:
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display:
  v: Computable Publishing LLC

text:
  v: FEvIR Linking Identifier

v: NCT03640312-secondaryOutcomeMeasure-8--OG000

display:
  v: Computable Publishing LLC

text:
  v: FEvIR Linking Identifier

v: NCT03640312-secondaryOutcomeMeasure-8--OG001

display:
  v: Computable Publishing LLC

text:
  v: FEvIR Linking Identifier

v: NCT03640312-secondaryOutcomeMeasure-8-OutcomeAnalysis-10-BetweenGroupAnalysis-OG000-OG001

display:
  v: Computable Publishing LLC

title:
  v: Percentage of Participants With Serious Adverse Events (SAEs) at 12 weeks
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  display:
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    v: Outcome Measure Reporting Status
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      v: OutcomeMeasureReportingStatus
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section:
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    v: Outcome Measure Time Frame
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      v: OutcomeMeasureTimeFrame
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section:
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      v: QUARTET LDQT
    code:
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        v: OG000
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      status:
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        v: 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.
    entry:
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        v: 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.
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    title:
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    code:
      text:
        v: OG001
    text:
      status:
        v: generated
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        v: Patients randomized to the comparison arm took a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
    entry:
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        v: Patients randomized to the comparison arm took a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
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  section:
    title:
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        v: Percentage of Participants With Serious Adverse Events (SAEs) at 12 weeks (NCT03640312)
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        v: Percentage of Participants With Serious Adverse Events (SAEs) at 12 weeks for QUARTET LDQT in NCT03640312
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        v: Evidence
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        v: Percentage of Participants With Serious Adverse Events (SAEs) at 12 weeks for Candesartan in NCT03640312
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        v: Percentage of Participants With Serious Adverse Events (SAEs) at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312

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v: Results

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text:
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        v: Rate of Adverse Events of Special Interest at 12 weeks for QUARTET LDQT in NCT03640312
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        v: Rate of Adverse Events of Special Interest at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312

v: results

v: Results

text:
  v: FEvIR Linking Identifier

v: NCT03640312-otherOutcome-2

display:
  v: Computable Publishing LLC

text:
  v: FEvIR Linking Identifier

v: NCT03640312-otherOutcomeMeasure-2--OG000

display:
  v: Computable Publishing LLC

text:
  v: FEvIR Linking Identifier

v: NCT03640312-otherOutcomeMeasure-2--OG001

display:
  v: Computable Publishing LLC

text:
  v: FEvIR Linking Identifier

v: NCT03640312-otherOutcomeMeasure-2-OutcomeAnalysis-13-BetweenGroupAnalysis-OG000-OG001

display:
  v: Computable Publishing LLC

title:
  v: Mean Change in Serum Potassium at 12 weeks
focus:
  l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/367899
  reference:
    v: EvidenceVariable/367899
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  identifier:
    type:
      text:
        v: FEvIR Linking Identifier
    system:
      v: https://fevir.net/FLI
      l: FLI
    value:
      v: NCT03640312-otherOutcome-3
    assigner:
      display:
        v: Computable Publishing LLC
  display:
    v: Mean Change in Serum Potassium at 12 weeks (NCT03640312)
section:
  title:
    v: Outcome Measure Population Description
  code:
    text:
      v: OutcomeMeasurePopulationDescription
  text:
    status:
      v: generated
    div:
      v: Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.
section:
  title:
    v: Outcome Measure Reporting Status
  code:
    text:
      v: OutcomeMeasureReportingStatus
  text:
    status:
      v: generated
    div:
      v: Posted
section:
  title:
    v: Outcome Measure Time Frame
  code:
    text:
      v: OutcomeMeasureTimeFrame
  text:
    status:
      v: generated
    div:
      v: 12 weeks
section:
  title:
    v: Outcome Group List
  code:
    text:
      v: OutcomeGroupList
  section:
    title:
      v: QUARTET LDQT
    code:
      text:
        v: OG000
    text:
      status:
        v: generated
      div:
        v: 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.
    entry:
      display:
        v: 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.
  section:
    title:
      v: Candesartan
    code:
      text:
        v: OG001
    text:
      status:
        v: generated
      div:
        v: Patients randomized to the comparison arm took a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
    entry:
      display:
        v: Patients randomized to the comparison arm took a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
section:
  title:
    v: Outcome Class List
  code:
    text:
      v: OutcomeClassList
  section:
    title:
      v: Mean Change in Serum Potassium at 12 weeks (NCT03640312)
    focus:
      l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/367899
      reference:
        v: EvidenceVariable/367899
      type:
        v: EvidenceVariable
        l: EvidenceVariable
      display:
        v: Mean Change in Serum Potassium at 12 weeks (NCT03640312)
    entry:
      l: http://hl7.org/fhir/uv/ebm/Evidence/367933
      reference:
        v: Evidence/367933
      type:
        v: Evidence
        l: Evidence
      display:
        v: Mean Change in Serum Potassium at 12 weeks for QUARTET LDQT in NCT03640312
    entry:
      l: http://hl7.org/fhir/uv/ebm/Evidence/367934
      reference:
        v: Evidence/367934
      type:
        v: Evidence
        l: Evidence
      display:
        v: Mean Change in Serum Potassium at 12 weeks for Candesartan in NCT03640312
    entry:
      l: http://hl7.org/fhir/uv/ebm/Evidence/367955
      reference:
        v: Evidence/367955
      type:
        v: Evidence
        l: Evidence
      display:
        v: Mean Change in Serum Potassium at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312

v: results

v: Results

text:
  v: FEvIR Linking Identifier

v: NCT03640312-otherOutcome-3

display:
  v: Computable Publishing LLC

text:
  v: FEvIR Linking Identifier

v: NCT03640312-otherOutcomeMeasure-3--OG000

display:
  v: Computable Publishing LLC

text:
  v: FEvIR Linking Identifier

v: NCT03640312-otherOutcomeMeasure-3--OG001

display:
  v: Computable Publishing LLC

text:
  v: FEvIR Linking Identifier

v: NCT03640312-otherOutcomeMeasure-3-OutcomeAnalysis-14-BetweenGroupAnalysis-OG000-OG001

display:
  v: Computable Publishing LLC

title:
  v: Mean Change in Serum Sodium at 12 weeks
focus:
  l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/367900
  reference:
    v: EvidenceVariable/367900
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  identifier:
    type:
      text:
        v: FEvIR Linking Identifier
    system:
      v: https://fevir.net/FLI
      l: FLI
    value:
      v: NCT03640312-otherOutcome-4
    assigner:
      display:
        v: Computable Publishing LLC
  display:
    v: Mean Change in Serum Sodium at 12 weeks (NCT03640312)
section:
  title:
    v: Outcome Measure Population Description
  code:
    text:
      v: OutcomeMeasurePopulationDescription
  text:
    status:
      v: generated
    div:
      v: Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.
section:
  title:
    v: Outcome Measure Reporting Status
  code:
    text:
      v: OutcomeMeasureReportingStatus
  text:
    status:
      v: generated
    div:
      v: Posted
section:
  title:
    v: Outcome Measure Time Frame
  code:
    text:
      v: OutcomeMeasureTimeFrame
  text:
    status:
      v: generated
    div:
      v: 12 weeks
section:
  title:
    v: Outcome Group List
  code:
    text:
      v: OutcomeGroupList
  section:
    title:
      v: QUARTET LDQT
    code:
      text:
        v: OG000
    text:
      status:
        v: generated
      div:
        v: 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.
    entry:
      display:
        v: 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.
  section:
    title:
      v: Candesartan
    code:
      text:
        v: OG001
    text:
      status:
        v: generated
      div:
        v: Patients randomized to the comparison arm took a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
    entry:
      display:
        v: Patients randomized to the comparison arm took a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
section:
  title:
    v: Outcome Class List
  code:
    text:
      v: OutcomeClassList
  section:
    title:
      v: Mean Change in Serum Sodium at 12 weeks (NCT03640312)
    focus:
      l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/367900
      reference:
        v: EvidenceVariable/367900
      type:
        v: EvidenceVariable
        l: EvidenceVariable
      display:
        v: Mean Change in Serum Sodium at 12 weeks (NCT03640312)
    entry:
      l: http://hl7.org/fhir/uv/ebm/Evidence/367935
      reference:
        v: Evidence/367935
      type:
        v: Evidence
        l: Evidence
      display:
        v: Mean Change in Serum Sodium at 12 weeks for QUARTET LDQT in NCT03640312
    entry:
      l: http://hl7.org/fhir/uv/ebm/Evidence/367936
      reference:
        v: Evidence/367936
      type:
        v: Evidence
        l: Evidence
      display:
        v: Mean Change in Serum Sodium at 12 weeks for Candesartan in NCT03640312
    entry:
      l: http://hl7.org/fhir/uv/ebm/Evidence/367956
      reference:
        v: Evidence/367956
      type:
        v: Evidence
        l: Evidence
      display:
        v: Mean Change in Serum Sodium at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312

v: results

v: Results

text:
  v: FEvIR Linking Identifier

v: NCT03640312-otherOutcome-4

display:
  v: Computable Publishing LLC

text:
  v: FEvIR Linking Identifier

v: NCT03640312-otherOutcomeMeasure-4--OG000

display:
  v: Computable Publishing LLC

text:
  v: FEvIR Linking Identifier

v: NCT03640312-otherOutcomeMeasure-4--OG001

display:
  v: Computable Publishing LLC

text:
  v: FEvIR Linking Identifier

v: NCT03640312-otherOutcomeMeasure-4-OutcomeAnalysis-15-BetweenGroupAnalysis-OG000-OG001

display:
  v: Computable Publishing LLC

title:
  v: Mean Change in Blood Urea Nitrogen at 12 weeks
focus:
  l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/367901
  reference:
    v: EvidenceVariable/367901
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  identifier:
    type:
      text:
        v: FEvIR Linking Identifier
    system:
      v: https://fevir.net/FLI
      l: FLI
    value:
      v: NCT03640312-otherOutcome-5
    assigner:
      display:
        v: Computable Publishing LLC
  display:
    v: Mean Change in Blood Urea Nitrogen at 12 weeks (NCT03640312)
section:
  title:
    v: Outcome Measure Population Description
  code:
    text:
      v: OutcomeMeasurePopulationDescription
  text:
    status:
      v: generated
    div:
      v: Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.
section:
  title:
    v: Outcome Measure Reporting Status
  code:
    text:
      v: OutcomeMeasureReportingStatus
  text:
    status:
      v: generated
    div:
      v: Posted
section:
  title:
    v: Outcome Measure Time Frame
  code:
    text:
      v: OutcomeMeasureTimeFrame
  text:
    status:
      v: generated
    div:
      v: 12 weeks
section:
  title:
    v: Outcome Group List
  code:
    text:
      v: OutcomeGroupList
  section:
    title:
      v: QUARTET LDQT
    code:
      text:
        v: OG000
    text:
      status:
        v: generated
      div:
        v: 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.
    entry:
      display:
        v: 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.
  section:
    title:
      v: Candesartan
    code:
      text:
        v: OG001
    text:
      status:
        v: generated
      div:
        v: Patients randomized to the comparison arm took a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
    entry:
      display:
        v: Patients randomized to the comparison arm took a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
section:
  title:
    v: Outcome Class List
  code:
    text:
      v: OutcomeClassList
  section:
    title:
      v: Mean Change in Blood Urea Nitrogen at 12 weeks (NCT03640312)
    focus:
      l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/367901
      reference:
        v: EvidenceVariable/367901
      type:
        v: EvidenceVariable
        l: EvidenceVariable
      display:
        v: Mean Change in Blood Urea Nitrogen at 12 weeks (NCT03640312)
    entry:
      l: http://hl7.org/fhir/uv/ebm/Evidence/367937
      reference:
        v: Evidence/367937
      type:
        v: Evidence
        l: Evidence
      display:
        v: Mean Change in Blood Urea Nitrogen at 12 weeks for QUARTET LDQT in NCT03640312
    entry:
      l: http://hl7.org/fhir/uv/ebm/Evidence/367938
      reference:
        v: Evidence/367938
      type:
        v: Evidence
        l: Evidence
      display:
        v: Mean Change in Blood Urea Nitrogen at 12 weeks for Candesartan in NCT03640312
    entry:
      l: http://hl7.org/fhir/uv/ebm/Evidence/367957
      reference:
        v: Evidence/367957
      type:
        v: Evidence
        l: Evidence
      display:
        v: Mean Change in Blood Urea Nitrogen at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312

v: results

v: Results

text:
  v: FEvIR Linking Identifier

v: NCT03640312-otherOutcome-5

display:
  v: Computable Publishing LLC

text:
  v: FEvIR Linking Identifier

v: NCT03640312-otherOutcomeMeasure-5--OG000

display:
  v: Computable Publishing LLC

text:
  v: FEvIR Linking Identifier

v: NCT03640312-otherOutcomeMeasure-5--OG001

display:
  v: Computable Publishing LLC

text:
  v: FEvIR Linking Identifier

v: NCT03640312-otherOutcomeMeasure-5-OutcomeAnalysis-16-BetweenGroupAnalysis-OG000-OG001

display:
  v: Computable Publishing LLC

title:
  v: Mean Change in Serum Creatinine at 12 weeks
focus:
  l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/367902
  reference:
    v: EvidenceVariable/367902
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  identifier:
    type:
      text:
        v: FEvIR Linking Identifier
    system:
      v: https://fevir.net/FLI
      l: FLI
    value:
      v: NCT03640312-otherOutcome-6
    assigner:
      display:
        v: Computable Publishing LLC
  display:
    v: Mean Change in Serum Creatinine at 12 weeks (NCT03640312)
section:
  title:
    v: Outcome Measure Population Description
  code:
    text:
      v: OutcomeMeasurePopulationDescription
  text:
    status:
      v: generated
    div:
      v: Modified intent to treat whereby all those participants with data at any follow-up time point and baseline to contribute to analyses will be included in analyses according to arm to which they were randomized, regardless of adherence to the study protocol.
section:
  title:
    v: Outcome Measure Reporting Status
  code:
    text:
      v: OutcomeMeasureReportingStatus
  text:
    status:
      v: generated
    div:
      v: Posted
section:
  title:
    v: Outcome Measure Time Frame
  code:
    text:
      v: OutcomeMeasureTimeFrame
  text:
    status:
      v: generated
    div:
      v: 12 weeks
section:
  title:
    v: Outcome Group List
  code:
    text:
      v: OutcomeGroupList
  section:
    title:
      v: QUARTET LDQT
    code:
      text:
        v: OG000
    text:
      status:
        v: generated
      div:
        v: 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.
    entry:
      display:
        v: 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.
  section:
    title:
      v: Candesartan
    code:
      text:
        v: OG001
    text:
      status:
        v: generated
      div:
        v: Patients randomized to the comparison arm took a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
    entry:
      display:
        v: Patients randomized to the comparison arm took a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
section:
  title:
    v: Outcome Class List
  code:
    text:
      v: OutcomeClassList
  section:
    title:
      v: Mean Change in Serum Creatinine at 12 weeks (NCT03640312)
    focus:
      l: http://hl7.org/fhir/uv/ebm/EvidenceVariable/367902
      reference:
        v: EvidenceVariable/367902
      type:
        v: EvidenceVariable
        l: EvidenceVariable
      display:
        v: Mean Change in Serum Creatinine at 12 weeks (NCT03640312)
    entry:
      l: http://hl7.org/fhir/uv/ebm/Evidence/367939
      reference:
        v: Evidence/367939
      type:
        v: Evidence
        l: Evidence
      display:
        v: Mean Change in Serum Creatinine at 12 weeks for QUARTET LDQT in NCT03640312
    entry:
      l: http://hl7.org/fhir/uv/ebm/Evidence/367940
      reference:
        v: Evidence/367940
      type:
        v: Evidence
        l: Evidence
      display:
        v: Mean Change in Serum Creatinine at 12 weeks for Candesartan in NCT03640312
    entry:
      l: http://hl7.org/fhir/uv/ebm/Evidence/367958
      reference:
        v: Evidence/367958
      type:
        v: Evidence
        l: Evidence
      display:
        v: Mean Change in Serum Creatinine at 12 weeks Statistical Analysis for QUARTET LDQT vs Candesartan in NCT03640312

v: results

v: Results

text:
  v: FEvIR Linking Identifier

v: NCT03640312-otherOutcome-6

display:
  v: Computable Publishing LLC

text:
  v: FEvIR Linking Identifier

v: NCT03640312-otherOutcomeMeasure-6--OG000

display:
  v: Computable Publishing LLC

text:
  v: FEvIR Linking Identifier

v: NCT03640312-otherOutcomeMeasure-6--OG001

display:
  v: Computable Publishing LLC

text:
  v: FEvIR Linking Identifier

v: NCT03640312-otherOutcomeMeasure-6-OutcomeAnalysis-17-BetweenGroupAnalysis-OG000-OG001

display:
  v: Computable Publishing LLC