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Packagehl7.fhir.uv.ebm
Resource TypeComposition
IdComposition-370510.json
FHIR VersionR6

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Narrative

Note: links and images are rebased to the (stated) source

Generated Narrative: Composition 370510

version: 12; Last updated: 2025-10-11 10:35:13+0000; Language: en-US

Profile: BaselineMeasureReport

Artifact Description:

Example for EBMonFHIR IG

ArtifactPublicationStatus: Active

url: https://fevir.net/resources/Composition/370510

identifier: FEvIR Object Identifier/370510, FEvIR Linking Identifier/NCT03640312-baseline-measure-report

status: Final

type: Baseline Measure Report

date: 2025-10-11 10:35:13+0000

author: Joanne Dehnbostel

title: Baseline Characteristics Report for QUARTET Trial

custodian: Computable Publishing LLC

relatesTo

type: Cite As

target:

Baseline Characteristics Report for QUARTET Trial [Database Entry: FHIR Composition Resource]. Contributors: Joanne Dehnbostel [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 370510. Revised 2025-10-11. Available at: https://fevir.net/resources/Composition/370510. Computable resource at: https://fevir.net/resources/Composition/370510#json.

relatesTo

type: Derived From

target: Baseline Characteristics Report for NCT03640312


Generated Narrative: EvidenceVariable #NCT03640312-BaselineMeasure-0

EvidenceVariableHandlingDetail: Evidence variable handling not specified

title: Age, Continuous

status: Active

Definitions

-Reference
*Group: membership = conceptual

handling: extension

classifier: Baseline Measure


Generated Narrative: Group #variable-definition-NCT03640312-BaselineMeasure-0

membership: Conceptual

characteristic

code: defined by CodeableConcept

value: Age, Continuous

exclude: false

Timings

-Offset[x]
*No display for Duration (value: 0)

Generated Narrative: EvidenceVariable #NCT03640312-BaselineMeasure-1

EvidenceVariableHandlingDetail: Evidence variable handling not specified

title: Sex: Female, Male

status: Active

Definitions

-Reference
*Group: membership = conceptual

handling: extension

category

name: Female

category

name: Male

classifier: Baseline Measure


Generated Narrative: Group #variable-definition-NCT03640312-BaselineMeasure-1

membership: Conceptual

characteristic

code: defined by CodeableConcept

value: Sex: Female, Male

exclude: false

Timings

-Offset[x]
*No display for Duration (value: 0)

Generated Narrative: EvidenceVariable #NCT03640312-BaselineMeasure-2

EvidenceVariableHandlingDetail: Evidence variable handling not specified

title: Race/Ethnicity, Customized

status: Active

Definitions

-Reference
*Group: membership = conceptual

handling: extension

category

name: Race/Ethnicity:: Hispanic

category

name: Race/Ethnicity:: Black/Sub Saharan African

category

name: Race/Ethnicity:: White/Caucasian/Other

classifier: Baseline Measure


Generated Narrative: Group #variable-definition-NCT03640312-BaselineMeasure-2

membership: Conceptual

characteristic

code: defined by CodeableConcept

value: Race/Ethnicity, Customized

exclude: false

Timings

-Offset[x]
*No display for Duration (value: 0)

Generated Narrative: EvidenceVariable #NCT03640312-BaselineMeasure-3

EvidenceVariableHandlingDetail: Evidence variable handling not specified

title: Body Mass Index, kg/m^2

status: Active

Definitions

-Reference
*Group: membership = conceptual

handling: extension

classifier: Baseline Measure


Generated Narrative: Group #variable-definition-NCT03640312-BaselineMeasure-3

membership: Conceptual

characteristic

code: defined by CodeableConcept

value: Body Mass Index, kg/m^2

exclude: false

Timings

-Offset[x]
*No display for Duration (value: 0)

Generated Narrative: EvidenceVariable #NCT03640312-BaselineMeasure-4

EvidenceVariableHandlingDetail: Evidence variable handling not specified

title: Heart rate, beats per minute

status: Active

Definitions

-Reference
*Group: membership = conceptual

handling: extension

classifier: Baseline Measure


Generated Narrative: Group #variable-definition-NCT03640312-BaselineMeasure-4

membership: Conceptual

characteristic

code: defined by CodeableConcept

value: Heart rate, beats per minute

exclude: false

Timings

-Offset[x]
*No display for Duration (value: 0)

Generated Narrative: EvidenceVariable #NCT03640312-BaselineMeasure-5

EvidenceVariableHandlingDetail: Evidence variable handling not specified

title: History of diabetes, n (%)

status: Active

Definitions

-Reference
*Group: membership = conceptual

handling: extension

classifier: Baseline Measure


Generated Narrative: Group #variable-definition-NCT03640312-BaselineMeasure-5

membership: Conceptual

characteristic

code: defined by CodeableConcept

value: History of diabetes, n (%)

exclude: false

Timings

-Offset[x]
*No display for Duration (value: 0)

Generated Narrative: EvidenceVariable #NCT03640312-BaselineMeasure-6

EvidenceVariableHandlingDetail: Evidence variable handling not specified

title: History of smoking, n (%)

status: Active

Definitions

-Reference
*Group: membership = conceptual

handling: extension

classifier: Baseline Measure


Generated Narrative: Group #variable-definition-NCT03640312-BaselineMeasure-6

membership: Conceptual

characteristic

code: defined by CodeableConcept

value: History of smoking, n (%)

exclude: false

Timings

-Offset[x]
*No display for Duration (value: 0)

Generated Narrative: EvidenceVariable #NCT03640312-BaselineMeasure-7

EvidenceVariableHandlingDetail: Evidence variable handling not specified

title: History of depression, n (%)

status: Active

Definitions

-Reference
*Group: membership = conceptual

handling: extension

classifier: Baseline Measure


Generated Narrative: Group #variable-definition-NCT03640312-BaselineMeasure-7

membership: Conceptual

characteristic

code: defined by CodeableConcept

value: History of depression, n (%)

exclude: false

Timings

-Offset[x]
*No display for Duration (value: 0)

Generated Narrative: EvidenceVariable #NCT03640312-BaselineMeasure-8

EvidenceVariableHandlingDetail: Evidence variable handling not specified

title: Weekly alcohol use, n (%)

status: Active

Definitions

-Reference
*Group: membership = conceptual

handling: extension

classifier: Baseline Measure


Generated Narrative: Group #variable-definition-NCT03640312-BaselineMeasure-8

membership: Conceptual

characteristic

code: defined by CodeableConcept

value: Weekly alcohol use, n (%)

exclude: false

Timings

-Offset[x]
*No display for Duration (value: 0)

Generated Narrative: EvidenceVariable #NCT03640312-BaselineMeasure-9

EvidenceVariableHandlingDetail: Evidence variable handling not specified

title: Systolic Blood Pressure, mm Hg

status: Active

Definitions

-Reference
*Group: membership = conceptual

handling: extension

classifier: Baseline Measure


Generated Narrative: Group #variable-definition-NCT03640312-BaselineMeasure-9

membership: Conceptual

characteristic

code: defined by CodeableConcept

value: Systolic Blood Pressure, mm Hg

exclude: false

Timings

-Offset[x]
*No display for Duration (value: 0)

Generated Narrative: EvidenceVariable #NCT03640312-BaselineMeasure-10

EvidenceVariableHandlingDetail: Evidence variable handling not specified

title: Diastolic Blood Pressure, mm Hg

status: Active

Definitions

-Reference
*Group: membership = conceptual

handling: extension

classifier: Baseline Measure


Generated Narrative: Group #variable-definition-NCT03640312-BaselineMeasure-10

membership: Conceptual

characteristic

code: defined by CodeableConcept

value: Diastolic Blood Pressure, mm Hg

exclude: false

Timings

-Offset[x]
*No display for Duration (value: 0)

Generated Narrative: Group #BG000

name: 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 ΒΌ 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: Person

membership: Enumerated

code: Participants

quantity: 32

Characteristics

-CodeValue[x]Exclude
*Research Study from which this is a baseline groupNCT03640312false

Generated Narrative: Group #BG001

name: Candesartan

description:

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: Person

membership: Enumerated

code: Participants

quantity: 30

Characteristics

-CodeValue[x]Exclude
*Research Study from which this is a baseline groupNCT03640312false

Generated Narrative: Group #BG002

name: Total

description:

Total of all reporting groups

type: Person

membership: Enumerated

code: Participants

quantity: 62

Characteristics

-CodeValue[x]Exclude
*Research Study from which this is a baseline groupNCT03640312false

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-0-BG000

name: NCT03640312_BaselineMeasure_0_BG000

title: Age, Continuous for QUARTET LDQT at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: QUARTET LDQT

variableDefinition

variableRole: Outcome

observed: Age, Continuous

statistic

statisticType: mean

quantity: 52 years

SampleSizes

-KnownDataCount
*32

AttributeEstimates

-TypeQuantity
*Standard Deviation12.6 years

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-0-BG001

name: NCT03640312_BaselineMeasure_0_BG001

title: Age, Continuous for Candesartan at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Candesartan

variableDefinition

variableRole: Outcome

observed: Age, Continuous

statistic

statisticType: mean

quantity: 52 years

SampleSizes

-KnownDataCount
*30

AttributeEstimates

-TypeQuantity
*Standard Deviation10.5 years

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-0-BG002

name: NCT03640312_BaselineMeasure_0_BG002

title: Age, Continuous for Total at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Total

variableDefinition

variableRole: Outcome

observed: Age, Continuous

statistic

statisticType: mean

quantity: 52 years

SampleSizes

-KnownDataCount
*62

AttributeEstimates

-TypeQuantity
*Standard Deviation11.5 years

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-1-BG000

name: NCT03640312_BaselineMeasure_1_BG000

title: Sex: Female, Male for QUARTET LDQT at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: QUARTET LDQT

variableDefinition

variableRole: Outcome

observed: Sex: Female, Male

statistic

statisticType: Count of Participants

category: Female

quantity: 15 Participants

SampleSizes

-KnownDataCount
*32

statistic

statisticType: Count of Participants

category: Male

quantity: 17 Participants

SampleSizes

-KnownDataCount
*32

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-1-BG001

name: NCT03640312_BaselineMeasure_1_BG001

title: Sex: Female, Male for Candesartan at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Candesartan

variableDefinition

variableRole: Outcome

observed: Sex: Female, Male

statistic

statisticType: Count of Participants

category: Female

quantity: 13 Participants

SampleSizes

-KnownDataCount
*30

statistic

statisticType: Count of Participants

category: Male

quantity: 17 Participants

SampleSizes

-KnownDataCount
*30

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-1-BG002

name: NCT03640312_BaselineMeasure_1_BG002

title: Sex: Female, Male for Total at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Total

variableDefinition

variableRole: Outcome

observed: Sex: Female, Male

statistic

statisticType: Count of Participants

category: Female

quantity: 28 Participants

SampleSizes

-KnownDataCount
*62

statistic

statisticType: Count of Participants

category: Male

quantity: 34 Participants

SampleSizes

-KnownDataCount
*62

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-2-BG000

name: NCT03640312_BaselineMeasure_2_BG000

title: Race/Ethnicity, Customized for QUARTET LDQT at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: QUARTET LDQT

variableDefinition

variableRole: Outcome

observed: Race/Ethnicity, Customized

statistic

statisticType: Count of Participants

category: Race/Ethnicity:: Hispanic

quantity: 24 Participants

SampleSizes

-KnownDataCount
*32

statistic

statisticType: Count of Participants

category: Race/Ethnicity:: Black/Sub Saharan African

quantity: 4 Participants

SampleSizes

-KnownDataCount
*32

statistic

statisticType: Count of Participants

category: Race/Ethnicity:: White/Caucasian/Other

quantity: 4 Participants

SampleSizes

-KnownDataCount
*32

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-2-BG001

name: NCT03640312_BaselineMeasure_2_BG001

title: Race/Ethnicity, Customized for Candesartan at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Candesartan

variableDefinition

variableRole: Outcome

observed: Race/Ethnicity, Customized

statistic

statisticType: Count of Participants

category: Race/Ethnicity:: Hispanic

quantity: 21 Participants

SampleSizes

-KnownDataCount
*30

statistic

statisticType: Count of Participants

category: Race/Ethnicity:: Black/Sub Saharan African

quantity: 7 Participants

SampleSizes

-KnownDataCount
*30

statistic

statisticType: Count of Participants

category: Race/Ethnicity:: White/Caucasian/Other

quantity: 2 Participants

SampleSizes

-KnownDataCount
*30

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-2-BG002

name: NCT03640312_BaselineMeasure_2_BG002

title: Race/Ethnicity, Customized for Total at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Total

variableDefinition

variableRole: Outcome

observed: Race/Ethnicity, Customized

statistic

statisticType: Count of Participants

category: Race/Ethnicity:: Hispanic

quantity: 45 Participants

SampleSizes

-KnownDataCount
*62

statistic

statisticType: Count of Participants

category: Race/Ethnicity:: Black/Sub Saharan African

quantity: 11 Participants

SampleSizes

-KnownDataCount
*62

statistic

statisticType: Count of Participants

category: Race/Ethnicity:: White/Caucasian/Other

quantity: 6 Participants

SampleSizes

-KnownDataCount
*62

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-3-BG000

name: NCT03640312_BaselineMeasure_3_BG000

title: Body Mass Index, kg/m^2 for QUARTET LDQT at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: QUARTET LDQT

variableDefinition

variableRole: Outcome

observed: Body Mass Index, kg/m^2

statistic

statisticType: mean

quantity: 33 kg/m^2

SampleSizes

-KnownDataCount
*32

AttributeEstimates

-TypeQuantity
*Standard Deviation6.9 kg/m^2

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-3-BG001

name: NCT03640312_BaselineMeasure_3_BG001

title: Body Mass Index, kg/m^2 for Candesartan at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Candesartan

variableDefinition

variableRole: Outcome

observed: Body Mass Index, kg/m^2

statistic

statisticType: mean

quantity: 34 kg/m^2

SampleSizes

-KnownDataCount
*30

AttributeEstimates

-TypeQuantity
*Standard Deviation7.9 kg/m^2

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-3-BG002

name: NCT03640312_BaselineMeasure_3_BG002

title: Body Mass Index, kg/m^2 for Total at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Total

variableDefinition

variableRole: Outcome

observed: Body Mass Index, kg/m^2

statistic

statisticType: mean

quantity: 34 kg/m^2

SampleSizes

-KnownDataCount
*62

AttributeEstimates

-TypeQuantity
*Standard Deviation7.3 kg/m^2

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-4-BG000

name: NCT03640312_BaselineMeasure_4_BG000

title: Heart rate, beats per minute for QUARTET LDQT at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: QUARTET LDQT

variableDefinition

variableRole: Outcome

observed: Heart rate, beats per minute

statistic

statisticType: mean

quantity: 71.5 beats per minute

SampleSizes

-KnownDataCount
*32

AttributeEstimates

-TypeQuantity
*Standard Deviation10 beats per minute

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-4-BG001

name: NCT03640312_BaselineMeasure_4_BG001

title: Heart rate, beats per minute for Candesartan at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Candesartan

variableDefinition

variableRole: Outcome

observed: Heart rate, beats per minute

statistic

statisticType: mean

quantity: 71.7 beats per minute

SampleSizes

-KnownDataCount
*30

AttributeEstimates

-TypeQuantity
*Standard Deviation11.7 beats per minute

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-4-BG002

name: NCT03640312_BaselineMeasure_4_BG002

title: Heart rate, beats per minute for Total at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Total

variableDefinition

variableRole: Outcome

observed: Heart rate, beats per minute

statistic

statisticType: mean

quantity: 71.6 beats per minute

SampleSizes

-KnownDataCount
*62

AttributeEstimates

-TypeQuantity
*Standard Deviation10.8 beats per minute

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-5-BG000

name: NCT03640312_BaselineMeasure_5_BG000

title: History of diabetes, n (%) for QUARTET LDQT at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: QUARTET LDQT

variableDefinition

variableRole: Outcome

observed: History of diabetes, n (%)

statistic

statisticType: Count of Participants

quantity: 10 Participants

SampleSizes

-KnownDataCount
*32

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-5-BG001

name: NCT03640312_BaselineMeasure_5_BG001

title: History of diabetes, n (%) for Candesartan at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Candesartan

variableDefinition

variableRole: Outcome

observed: History of diabetes, n (%)

statistic

statisticType: Count of Participants

quantity: 7 Participants

SampleSizes

-KnownDataCount
*30

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-5-BG002

name: NCT03640312_BaselineMeasure_5_BG002

title: History of diabetes, n (%) for Total at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Total

variableDefinition

variableRole: Outcome

observed: History of diabetes, n (%)

statistic

statisticType: Count of Participants

quantity: 17 Participants

SampleSizes

-KnownDataCount
*62

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-6-BG000

name: NCT03640312_BaselineMeasure_6_BG000

title: History of smoking, n (%) for QUARTET LDQT at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: QUARTET LDQT

variableDefinition

variableRole: Outcome

observed: History of smoking, n (%)

statistic

statisticType: Count of Participants

quantity: 11 Participants

SampleSizes

-KnownDataCount
*32

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-6-BG001

name: NCT03640312_BaselineMeasure_6_BG001

title: History of smoking, n (%) for Candesartan at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Candesartan

variableDefinition

variableRole: Outcome

observed: History of smoking, n (%)

statistic

statisticType: Count of Participants

quantity: 9 Participants

SampleSizes

-KnownDataCount
*30

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-6-BG002

name: NCT03640312_BaselineMeasure_6_BG002

title: History of smoking, n (%) for Total at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Total

variableDefinition

variableRole: Outcome

observed: History of smoking, n (%)

statistic

statisticType: Count of Participants

quantity: 20 Participants

SampleSizes

-KnownDataCount
*62

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-7-BG000

name: NCT03640312_BaselineMeasure_7_BG000

title: History of depression, n (%) for QUARTET LDQT at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: QUARTET LDQT

variableDefinition

variableRole: Outcome

observed: History of depression, n (%)

statistic

statisticType: Count of Participants

quantity: 7 Participants

SampleSizes

-KnownDataCount
*32

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-7-BG001

name: NCT03640312_BaselineMeasure_7_BG001

title: History of depression, n (%) for Candesartan at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Candesartan

variableDefinition

variableRole: Outcome

observed: History of depression, n (%)

statistic

statisticType: Count of Participants

quantity: 9 Participants

SampleSizes

-KnownDataCount
*30

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-7-BG002

name: NCT03640312_BaselineMeasure_7_BG002

title: History of depression, n (%) for Total at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Total

variableDefinition

variableRole: Outcome

observed: History of depression, n (%)

statistic

statisticType: Count of Participants

quantity: 16 Participants

SampleSizes

-KnownDataCount
*62

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-8-BG000

name: NCT03640312_BaselineMeasure_8_BG000

title: Weekly alcohol use, n (%) for QUARTET LDQT at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: QUARTET LDQT

variableDefinition

variableRole: Outcome

observed: Weekly alcohol use, n (%)

statistic

statisticType: Count of Participants

quantity: 10 Participants

SampleSizes

-KnownDataCount
*32

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-8-BG001

name: NCT03640312_BaselineMeasure_8_BG001

title: Weekly alcohol use, n (%) for Candesartan at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Candesartan

variableDefinition

variableRole: Outcome

observed: Weekly alcohol use, n (%)

statistic

statisticType: Count of Participants

quantity: 9 Participants

SampleSizes

-KnownDataCount
*30

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-8-BG002

name: NCT03640312_BaselineMeasure_8_BG002

title: Weekly alcohol use, n (%) for Total at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Total

variableDefinition

variableRole: Outcome

observed: Weekly alcohol use, n (%)

statistic

statisticType: Count of Participants

quantity: 19 Participants

SampleSizes

-KnownDataCount
*62

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-9-BG000

name: NCT03640312_BaselineMeasure_9_BG000

title: Systolic Blood Pressure, mm Hg for QUARTET LDQT at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: QUARTET LDQT

variableDefinition

variableRole: Outcome

observed: Systolic Blood Pressure, mm Hg

statistic

statisticType: mean

quantity: 137.6 mm Hg

SampleSizes

-KnownDataCount
*32

AttributeEstimates

-TypeQuantity
*Standard Deviation11.8 mm Hg

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-9-BG001

name: NCT03640312_BaselineMeasure_9_BG001

title: Systolic Blood Pressure, mm Hg for Candesartan at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Candesartan

variableDefinition

variableRole: Outcome

observed: Systolic Blood Pressure, mm Hg

statistic

statisticType: mean

quantity: 138.7 mm Hg

SampleSizes

-KnownDataCount
*30

AttributeEstimates

-TypeQuantity
*Standard Deviation10.8 mm Hg

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-9-BG002

name: NCT03640312_BaselineMeasure_9_BG002

title: Systolic Blood Pressure, mm Hg for Total at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Total

variableDefinition

variableRole: Outcome

observed: Systolic Blood Pressure, mm Hg

statistic

statisticType: mean

quantity: 138.1 mm Hg

SampleSizes

-KnownDataCount
*62

AttributeEstimates

-TypeQuantity
*Standard Deviation11.2 mm Hg

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-10-BG000

name: NCT03640312_BaselineMeasure_10_BG000

title: Diastolic Blood Pressure, mm Hg for QUARTET LDQT at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: QUARTET LDQT

variableDefinition

variableRole: Outcome

observed: Diastolic Blood Pressure, mm Hg

statistic

statisticType: mean

quantity: 84.3 mm Hg

SampleSizes

-KnownDataCount
*32

AttributeEstimates

-TypeQuantity
*Standard Deviation9.6 mm Hg

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-10-BG001

name: NCT03640312_BaselineMeasure_10_BG001

title: Diastolic Blood Pressure, mm Hg for Candesartan at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Candesartan

variableDefinition

variableRole: Outcome

observed: Diastolic Blood Pressure, mm Hg

statistic

statisticType: mean

quantity: 84.3 mm Hg

SampleSizes

-KnownDataCount
*30

AttributeEstimates

-TypeQuantity
*Standard Deviation11.5 mm Hg

Generated Narrative: Evidence #NCT03640312-BaselineMeasure-10-BG002

name: NCT03640312_BaselineMeasure_10_BG002

title: Diastolic Blood Pressure, mm Hg for Total at baseline in NCT03640312

status: Active

variableDefinition

variableRole: Population

observed: Total

variableDefinition

variableRole: Outcome

observed: Diastolic Blood Pressure, mm Hg

statistic

statisticType: mean

quantity: 84.3 mm Hg

SampleSizes

-KnownDataCount
*62

AttributeEstimates

-TypeQuantity
*Standard Deviation10.5 mm Hg

Source1

{
  "resourceType": "Composition",
  "id": "370510",
  "meta": {
    "versionId": "12",
    "lastUpdated": "2025-10-11T10:35:13.276Z",
    "profile": [
      "http://hl7.org/fhir/uv/ebm/StructureDefinition/baseline-measure-report"
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      "targetMarkdown": "Baseline Characteristics Report for QUARTET Trial [Database Entry: FHIR Composition Resource]. Contributors: Joanne Dehnbostel [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 370510. Revised 2025-10-11. Available at: https://fevir.net/resources/Composition/370510. Computable resource at: https://fevir.net/resources/Composition/370510#json."
    },
    {
      "type": "derived-from",
      "targetReference": {
        "reference": "Composition/370503",
        "type": "Composition",
        "display": "Baseline Characteristics Report for NCT03640312"
      }
    }
  ],
  "section": [
    {
      "title": "Age, Continuous",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "results",
            "display": "Results"
          }
        ]
      },
      "focus": {
        "reference": "#NCT03640312-BaselineMeasure-0",
        "type": "EvidenceVariable",
        "display": "Age, Continuous"
      },
      "text": {
        "status": "empty",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
      },
      "entry": [
        {
          "reference": "#NCT03640312-BaselineMeasure-0-BG000",
          "type": "Evidence",
          "display": "Age, Continuous for QUARTET LDQT at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-0-BG001",
          "type": "Evidence",
          "display": "Age, Continuous for Candesartan at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-0-BG002",
          "type": "Evidence",
          "display": "Age, Continuous for Total at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-0-BG002",
          "type": "Evidence",
          "display": "Age, Continuous for Total at baseline in NCT03640312"
        }
      ]
    },
    {
      "title": "Sex: Female, Male",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "results",
            "display": "Results"
          }
        ]
      },
      "focus": {
        "reference": "#NCT03640312-BaselineMeasure-1",
        "type": "EvidenceVariable",
        "display": "Sex: Female, Male"
      },
      "text": {
        "status": "empty",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
      },
      "entry": [
        {
          "reference": "#NCT03640312-BaselineMeasure-1-BG000",
          "type": "Evidence",
          "display": "Sex: Female, Male for QUARTET LDQT at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-1-BG001",
          "type": "Evidence",
          "display": "Sex: Female, Male for Candesartan at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-1-BG002",
          "type": "Evidence",
          "display": "Sex: Female, Male for Total at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-1-BG002",
          "type": "Evidence",
          "display": "Sex: Female, Male for Total at baseline in NCT03640312"
        }
      ]
    },
    {
      "title": "Race/Ethnicity, Customized",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "results",
            "display": "Results"
          }
        ]
      },
      "focus": {
        "reference": "#NCT03640312-BaselineMeasure-2",
        "type": "EvidenceVariable",
        "display": "Race/Ethnicity, Customized"
      },
      "text": {
        "status": "empty",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
      },
      "entry": [
        {
          "reference": "#NCT03640312-BaselineMeasure-2-BG000",
          "type": "Evidence",
          "display": "Race/Ethnicity, Customized for QUARTET LDQT at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-2-BG001",
          "type": "Evidence",
          "display": "Race/Ethnicity, Customized for Candesartan at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-2-BG002",
          "type": "Evidence",
          "display": "Race/Ethnicity, Customized for Total at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-2-BG002",
          "type": "Evidence",
          "display": "Race/Ethnicity, Customized for Total at baseline in NCT03640312"
        }
      ]
    },
    {
      "title": "Body Mass Index, kg/m^2",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "results",
            "display": "Results"
          }
        ]
      },
      "focus": {
        "reference": "#NCT03640312-BaselineMeasure-3",
        "type": "EvidenceVariable",
        "display": "Body Mass Index, kg/m^2"
      },
      "text": {
        "status": "empty",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
      },
      "entry": [
        {
          "reference": "#NCT03640312-BaselineMeasure-3-BG000",
          "type": "Evidence",
          "display": "Body Mass Index, kg/m^2 for QUARTET LDQT at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-3-BG001",
          "type": "Evidence",
          "display": "Body Mass Index, kg/m^2 for Candesartan at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-3-BG002",
          "type": "Evidence",
          "display": "Body Mass Index, kg/m^2 for Total at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-3-BG002",
          "type": "Evidence",
          "display": "Body Mass Index, kg/m^2 for Total at baseline in NCT03640312"
        }
      ]
    },
    {
      "title": "Heart rate, beats per minute",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "results",
            "display": "Results"
          }
        ]
      },
      "focus": {
        "reference": "#NCT03640312-BaselineMeasure-4",
        "type": "EvidenceVariable",
        "display": "Heart rate, beats per minute"
      },
      "text": {
        "status": "empty",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
      },
      "entry": [
        {
          "reference": "#NCT03640312-BaselineMeasure-4-BG000",
          "type": "Evidence",
          "display": "Heart rate, beats per minute for QUARTET LDQT at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-4-BG001",
          "type": "Evidence",
          "display": "Heart rate, beats per minute for Candesartan at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-4-BG002",
          "type": "Evidence",
          "display": "Heart rate, beats per minute for Total at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-4-BG002",
          "type": "Evidence",
          "display": "Heart rate, beats per minute for Total at baseline in NCT03640312"
        }
      ]
    },
    {
      "title": "History of diabetes, n (%)",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "results",
            "display": "Results"
          }
        ]
      },
      "focus": {
        "reference": "#NCT03640312-BaselineMeasure-5",
        "type": "EvidenceVariable",
        "display": "History of diabetes, n (%)"
      },
      "text": {
        "status": "empty",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
      },
      "entry": [
        {
          "reference": "#NCT03640312-BaselineMeasure-5-BG000",
          "type": "Evidence",
          "display": "History of diabetes, n (%) for QUARTET LDQT at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-5-BG001",
          "type": "Evidence",
          "display": "History of diabetes, n (%) for Candesartan at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-5-BG002",
          "type": "Evidence",
          "display": "History of diabetes, n (%) for Total at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-5-BG002",
          "type": "Evidence",
          "display": "History of diabetes, n (%) for Total at baseline in NCT03640312"
        }
      ]
    },
    {
      "title": "History of smoking, n (%)",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "results",
            "display": "Results"
          }
        ]
      },
      "focus": {
        "reference": "#NCT03640312-BaselineMeasure-6",
        "type": "EvidenceVariable",
        "display": "History of smoking, n (%)"
      },
      "text": {
        "status": "empty",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
      },
      "entry": [
        {
          "reference": "#NCT03640312-BaselineMeasure-6-BG000",
          "type": "Evidence",
          "display": "History of smoking, n (%) for QUARTET LDQT at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-6-BG001",
          "type": "Evidence",
          "display": "History of smoking, n (%) for Candesartan at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-6-BG002",
          "type": "Evidence",
          "display": "History of smoking, n (%) for Total at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-6-BG002",
          "type": "Evidence",
          "display": "History of smoking, n (%) for Total at baseline in NCT03640312"
        }
      ]
    },
    {
      "title": "History of depression, n (%)",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "results",
            "display": "Results"
          }
        ]
      },
      "focus": {
        "reference": "#NCT03640312-BaselineMeasure-7",
        "type": "EvidenceVariable",
        "display": "History of depression, n (%)"
      },
      "text": {
        "status": "empty",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
      },
      "entry": [
        {
          "reference": "#NCT03640312-BaselineMeasure-7-BG000",
          "type": "Evidence",
          "display": "History of depression, n (%) for QUARTET LDQT at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-7-BG001",
          "type": "Evidence",
          "display": "History of depression, n (%) for Candesartan at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-7-BG002",
          "type": "Evidence",
          "display": "History of depression, n (%) for Total at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-7-BG002",
          "type": "Evidence",
          "display": "History of depression, n (%) for Total at baseline in NCT03640312"
        }
      ]
    },
    {
      "title": "Weekly alcohol use, n (%)",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "results",
            "display": "Results"
          }
        ]
      },
      "focus": {
        "reference": "#NCT03640312-BaselineMeasure-8",
        "type": "EvidenceVariable",
        "display": "Weekly alcohol use, n (%)"
      },
      "text": {
        "status": "empty",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
      },
      "entry": [
        {
          "reference": "#NCT03640312-BaselineMeasure-8-BG000",
          "type": "Evidence",
          "display": "Weekly alcohol use, n (%) for QUARTET LDQT at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-8-BG001",
          "type": "Evidence",
          "display": "Weekly alcohol use, n (%) for Candesartan at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-8-BG002",
          "type": "Evidence",
          "display": "Weekly alcohol use, n (%) for Total at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-8-BG002",
          "type": "Evidence",
          "display": "Weekly alcohol use, n (%) for Total at baseline in NCT03640312"
        }
      ]
    },
    {
      "title": "Systolic Blood Pressure, mm Hg",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "results",
            "display": "Results"
          }
        ]
      },
      "focus": {
        "reference": "#NCT03640312-BaselineMeasure-9",
        "type": "EvidenceVariable",
        "display": "Systolic Blood Pressure, mm Hg"
      },
      "text": {
        "status": "empty",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
      },
      "entry": [
        {
          "reference": "#NCT03640312-BaselineMeasure-9-BG000",
          "type": "Evidence",
          "display": "Systolic Blood Pressure, mm Hg for QUARTET LDQT at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-9-BG001",
          "type": "Evidence",
          "display": "Systolic Blood Pressure, mm Hg for Candesartan at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-9-BG002",
          "type": "Evidence",
          "display": "Systolic Blood Pressure, mm Hg for Total at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-9-BG002",
          "type": "Evidence",
          "display": "Systolic Blood Pressure, mm Hg for Total at baseline in NCT03640312"
        }
      ]
    },
    {
      "title": "Diastolic Blood Pressure, mm Hg",
      "code": {
        "coding": [
          {
            "system": "https://fevir.net/resources/CodeSystem/179423",
            "code": "results",
            "display": "Results"
          }
        ]
      },
      "focus": {
        "reference": "#NCT03640312-BaselineMeasure-10",
        "type": "EvidenceVariable",
        "display": "Diastolic Blood Pressure, mm Hg"
      },
      "text": {
        "status": "empty",
        "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>[No data.]</p></div>"
      },
      "entry": [
        {
          "reference": "#NCT03640312-BaselineMeasure-10-BG000",
          "type": "Evidence",
          "display": "Diastolic Blood Pressure, mm Hg for QUARTET LDQT at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-10-BG001",
          "type": "Evidence",
          "display": "Diastolic Blood Pressure, mm Hg for Candesartan at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-10-BG002",
          "type": "Evidence",
          "display": "Diastolic Blood Pressure, mm Hg for Total at baseline in NCT03640312"
        },
        {
          "reference": "#NCT03640312-BaselineMeasure-10-BG002",
          "type": "Evidence",
          "display": "Diastolic Blood Pressure, mm Hg for Total at baseline in NCT03640312"
        }
      ]
    }
  ]
}