http://hl7.org/fhir/uv/ebm/Composition/370512
type: Composition
node role: treeRoot
id:
  v: 370512
meta:
  version id:
    v: 10
  last updated:
    v: 2025-10-21T11:07:38.408Z
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/participant-flow-report
    l: participant-flow-report
language:
  v: en
text:
  status:
    v: extensions
  div:
    v: Generated Narrative: Composition 370512 version: 10; Last updated: 2025-10-21 11:07:38+0000; Language: en Profile: ParticipantFlowReport Artifact Description: Example for EBMonFHIR IG ArtifactPublicationStatus: Active url: https://fevir.net/resources/Composition/370512 identifier: FEvIR Object Identifier/370512, FEvIR Linking Identifier/NCT03640312-participant-flow-report status: Final type: Participant Flow Report date: 2025-10-21 11:07:38+0000 author: Joanne Dehnbostel title: Participant Flow Report for QUARTET USA Trial custodian: Computable Publishing LLC relatesTo type: Cite As target: Participant Flow Report for QUARTET USA Trial [Database Entry: FHIR Composition Resource]. Contributors: Joanne Dehnbostel [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 370512. Revised 2025-10-21. Available at: https://fevir.net/resources/Composition/370512. Computable resource at: https://fevir.net/resources/Composition/370512#json. relatesTo type: Derived From target: Participant Flow Report for NCT03640312 Generated Narrative: Group #ScreenedGroup name: Group Screened for Participation for QUARTET USA Trial description: Potentially eligible patients screened for participation in the QUARTET USA Trial type: Person membership: Enumerated quantity: 120 Generated Narrative: Group #FG000 Profiles: ComparatorGroup, ExposureGroup, StudyGroup name: NCT03640312 Flow Group QUARTET LDQT description: 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…
contained: Group
  id:
    v: ScreenedGroup
  name:
    v: Group Screened for Participation for QUARTET USA Trial
  description:
    v: Potentially eligible patients screened for participation in the QUARTET USA Trial
  type:
    v: person
  membership:
    v: enumerated
  quantity:
    v: 120
contained: Group
  id:
    v: FG000
  meta:
    profile:
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      l: comparator-group
    profile:
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      l: exposure-group
    profile:
      v: http://hl7.org/fhir/uv/ebm/StructureDefinition/study-group
      l: study-group
  name:
    v: NCT03640312 Flow Group QUARTET LDQT
  description:
    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.
  type:
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  membership:
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  quantity:
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  characteristic:
    code:
      text:
        v: Research Study from which this is a flow group
    value: Reference
      display:
        v: NCT03640312
    exclude:
      v: false
contained: Group
  id:
    v: FG001
  name:
    v: NCT03640312 Flow Group Candesartan
  description:
    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.
  type:
    v: person
  membership:
    v: enumerated
  quantity:
    v: 30
  characteristic:
    code:
      text:
        v: Research Study from which this is a flow group
    value: Reference
      display:
        v: NCT03640312
    exclude:
      v: false
contained: Evidence
  id:
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  title:
    v: Excluded from QUARTET USA Trial
  status:
    v: active
  variable definition:
    description:
      v: Screened for Participation
    variable role:
      v: population
    observed:
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      reference:
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      type:
        v: Group
        l: Group
      display:
        v: Screened for Participation
  variable definition:
    description:
      v: Excluded
    variable role:
      v: outcome
    observed:
      type:
        v: EvidenceVariable
        l: EvidenceVariable
      display:
        v: Excluded
  statistic:
    quantity:
      value:
        v: 58
contained: Evidence
  id:
    v: ReasonsForExclusion
  title:
    v: Reasons for exclusion from QUARTET USA Trial
  status:
    v: active
  variable definition:
    description:
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    variable role:
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    observed:
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      reference:
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      type:
        v: Group
        l: Group
      display:
        v: Screened for Participation
  variable definition:
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    variable role:
      v: outcome
    observed:
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      reference:
        v: EvidenceVariable/372461
      type:
        v: EvidenceVariable
        l: EvidenceVariable
      display:
        v: Reasons for exclusion from QUARTET USA Trial
  statistic:
    category:
      text:
        v: Not meeting inclusion criteria
    quantity:
      value:
        v: 56
  statistic:
    category:
      text:
        v: Other reasons: "no-shows" for randomization
    quantity:
      value:
        v: 2
contained: Evidence
  id:
    v: NCT03640312-flow-milestone-0-Overall-Study-group-FG000
  meta:
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      l: participant-flow-evidence
  identifier:
    type:
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        v: FEvIR Linking Identifier
    system:
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      l: FLI
    value:
      v: NCT03640312-flow-milestone-0-Overall-Study-group-FG000
    assigner:
      display:
        v: Computable Publishing LLC
  title:
    v: ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - STARTED at Overall Study
  status:
    v: active
  author:
    name:
      v: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter
  use context:
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        l: https://fevir.net/resources/CodeSystem/179423
      code:
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    value: CodeableConcept

v: STATO:0000047

v: count

v: STATO:0000047

v: count

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v: count

v: Evidence Communication

CodeableConcept
coding:
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variable role:
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observed:
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  display:
    v: QUARTET LDQT

variable role:
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statistic type:
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quantity:
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Evidence
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  assigner:
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title:
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status:
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author:
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use context:
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variable definition:
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    type:
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    display:
      v: Candesartan
variable definition:
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statistic:
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Evidence
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  assigner:
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title:
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status:
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author:
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use context:
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variable definition:
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    type:
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    display:
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variable definition:
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  quantity:
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Evidence
id:
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meta:
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identifier:
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  value:
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  assigner:
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title:
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status:
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variable definition:
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    type:
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    display:
      v: Candesartan
variable definition:
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statistic:
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Evidence
id:
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meta:
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  assigner:
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title:
  v: ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - COMPLETED at Overall Study
status:
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author:
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use context:
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Evidence
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  assigner:
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title:
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status:
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      code:
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variable definition:
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variable definition:
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statistic:
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Evidence
id:
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  assigner:
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title:
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variable definition:
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      v: QUARTET LDQT
variable definition:
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Evidence
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title:
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Evidence
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title:
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  category:
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Evidence
id:
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title:
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variable definition:
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variable definition:
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        v: STATO:0000047
      display:
        v: Count
  category:
    text:
      v: Lost to Follow-up
  quantity:
    value:
      v: 6

url:
  v: http://hl7.org/fhir/StructureDefinition/artifact-description
  l: artifact-description
value: Markdown
  v: Example for EBMonFHIR IG

url:
  v: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status
  l: artifact-publication-status
value: CodeableConcept
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/cited-artifact-status-type
      l: cited-artifact-status-type
    code:
      v: active
    display:
      v: Active

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: 370512
assigner:
  display:
    v: Computable Publishing LLC

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

v: final

coding:
  system:
    v: https://fevir.net/resources/CodeSystem/179423
    l: https://fevir.net/resources/CodeSystem/179423
  code:
    v: ParticipantFlowReport
  display:
    v: ParticipantFlowReport
text:
  v: Participant Flow Report

v: 2025-10-21T11:07:38.408Z

display:
  v: Joanne Dehnbostel

v: Participant Flow Report for QUARTET USA Trial

l: http://hl7.org/fhir/uv/ebm/Organization/118079
reference:
  v: Organization/118079
type:
  v: Organization
  l: Organization
display:
  v: Computable Publishing LLC

type:
  v: cite-as
target: Markdown
  v: Participant Flow Report for QUARTET USA Trial [Database Entry: FHIR Composition Resource]. Contributors: Joanne Dehnbostel [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 370512. Revised 2025-10-21. Available at: https://fevir.net/resources/Composition/370512. Computable resource at: https://fevir.net/resources/Composition/370512#json.

type:
  v: derived-from
target: Reference
  l: http://hl7.org/fhir/uv/ebm/Composition/370502
  reference:
    v: Composition/370502
  type:
    v: Composition
    l: Composition
  display:
    v: Participant Flow Report for NCT03640312

title:
  v: Excluded
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Excluded
entry:
  l: ExcludedCount
  reference:
    v: #ExcludedCount
  type:
    v: Evidence
    l: Evidence
  display:
    v: Excluded from QUARTET USA Trial

title:
  v: Reasons for exclusion
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/372461
  reference:
    v: EvidenceVariable/372461
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Reasons for exclusion from QUARTET USA Trial
entry:
  l: ReasonsForExclusion
  reference:
    v: #ReasonsForExclusion
  type:
    v: Evidence
    l: Evidence
  display:
    v: Reasons for exclusion from QUARTET USA Trial

title:
  v: Flow PreAssignment Details
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: participant-flow-details
    display:
      v: Participant Flow Details
  text:
    v: FlowPreAssignmentDetails
text:
  status:
    v: generated
  div:
    v: NA - all enrolled participants were randomized.

title:
  v: Flow Recruitment Details
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: participant-flow-details
    display:
      v: Participant Flow Details
  text:
    v: FlowRecruitmentDetails
text:
  status:
    v: generated
  div:
    v: 120 were consented and assessed for eligibility. 58 were excluded for not meeting either inclusion or exclusion criteria, declining participation, or not showing up for randomization visits. Thus, these 58 individuals were not randomized, and 62 participants were randomized

title:
  v: Flow Group List
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: groups
    display:
      v: Groups
  text:
    v: FlowGroupList
text:
  status:
    v: generated
  div:
    v: QUARTET LDQT, Candesartan
entry:
  l: ScreenedGroup
  reference:
    v: #ScreenedGroup
  type:
    v: Group
    l: Group
  display:
    v: Screened for Participation
entry:
  l: FG000
  reference:
    v: #FG000
  type:
    v: Group
    l: Group
  display:
    v: QUARTET LDQT
entry:
  l: FG001
  reference:
    v: #FG001
  type:
    v: Group
    l: Group
  display:
    v: Candesartan

title:
  v: STARTED at Overall Study
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
  text:
    v: Participant Flow Results
focus:
  display:
    v: STARTED at Overall Study
text:
  status:
    v: empty
  div:
    v: [No data.]
entry:
  l: NCT03640312-flow-milestone-0-Overall-Study-group-FG000
  reference:
    v: #NCT03640312-flow-milestone-0-Overall-Study-group-FG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - STARTED at Overall Study
entry:
  l: NCT03640312-flow-milestone-0-Overall-Study-group-FG001
  reference:
    v: #NCT03640312-flow-milestone-0-Overall-Study-group-FG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: ParticipantFlowEvidence: NCT03640312 Candesartan - STARTED at Overall Study

title:
  v: 6 Week Follow Up at Overall Study
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
  text:
    v: Participant Flow Results
focus:
  display:
    v: 6 Week Follow Up at Overall Study
text:
  status:
    v: empty
  div:
    v: [No data.]
entry:
  l: NCT03640312-flow-milestone-1-Overall-Study-group-FG000
  reference:
    v: #NCT03640312-flow-milestone-1-Overall-Study-group-FG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - 6 Week Follow Up at Overall Study
entry:
  l: NCT03640312-flow-milestone-1-Overall-Study-group-FG001
  reference:
    v: #NCT03640312-flow-milestone-1-Overall-Study-group-FG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: ParticipantFlowEvidence: NCT03640312 Candesartan - 6 Week Follow Up at Overall Study

title:
  v: COMPLETED at Overall Study
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
  text:
    v: Participant Flow Results
focus:
  display:
    v: COMPLETED at Overall Study
text:
  status:
    v: empty
  div:
    v: [No data.]
entry:
  l: NCT03640312-flow-milestone-2-Overall-Study-group-FG000
  reference:
    v: #NCT03640312-flow-milestone-2-Overall-Study-group-FG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - COMPLETED at Overall Study
entry:
  l: NCT03640312-flow-milestone-2-Overall-Study-group-FG001
  reference:
    v: #NCT03640312-flow-milestone-2-Overall-Study-group-FG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: ParticipantFlowEvidence: NCT03640312 Candesartan - COMPLETED at Overall Study

title:
  v: NOT COMPLETED at Overall Study
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
  text:
    v: Participant Flow Results
focus:
  display:
    v: NOT COMPLETED at Overall Study
text:
  status:
    v: empty
  div:
    v: [No data.]
entry:
  l: NCT03640312-flow-milestone-3-Overall-Study-group-FG000
  reference:
    v: #NCT03640312-flow-milestone-3-Overall-Study-group-FG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - NOT COMPLETED at Overall Study
entry:
  l: NCT03640312-flow-milestone-3-Overall-Study-group-FG001
  reference:
    v: #NCT03640312-flow-milestone-3-Overall-Study-group-FG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: ParticipantFlowEvidence: NCT03640312 Candesartan - NOT COMPLETED at Overall Study

title:
  v: Reasons for withdraw at Overall Study
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
  text:
    v: Participant Flow Results
focus:
  display:
    v: Reasons for withdraw at Overall Study
text:
  status:
    v: empty
  div:
    v: [No data.]
entry:
  l: NCT03640312-flow-reason-Overall-Study-group-FG000
  reference:
    v: #NCT03640312-flow-reason-Overall-Study-group-FG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: ParticipantFlowEvidence: NCT03640312 QUARTET LDQT - Reasons for withdraw at Overall Study
entry:
  l: NCT03640312-flow-reason-Overall-Study-group-FG001
  reference:
    v: #NCT03640312-flow-reason-Overall-Study-group-FG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: ParticipantFlowEvidence: NCT03640312 Candesartan - Reasons for withdraw at Overall Study