Adverse Events Report for NCT03640312 - Evidence Based Medicine on FHIR Implementation Guide v1.0.0-ballot2

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

Example Composition: Adverse Events Report for NCT03640312

version: 25; Last updated: 2025-08-18 13:22:42+0000

Profile: OutcomeMeasureReport

ArtifactPublicationStatus: Active

url: https://fevir.net/resources/Composition/370505

identifier: FEvIR Object Identifier/370505, FEvIR Linking Identifier/NCT03640312-adverse-events-report

status: Final

type: Outcome Measure Report

date: 2025-08-18 13:22:42+0000

author: [No author listed.]

title: Adverse Events Report for NCT03640312

custodian: Computable Publishing LLC

RelatesTos

Type

Target[x]

Cite As

Adverse Events Report for NCT03640312 [Database Entry: FHIR Composition Resource]. Contributors: [No author listed.] [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 370505. Revised 2025-08-18. Available at: https://fevir.net/resources/Composition/370505. Computable resource at: https://fevir.net/FLI/DocumentForComposition370505.

Generated Narrative: EvidenceVariable #NCT03640312-AllCauseMortality

Profile: VariableDefinition
title: All-cause mortality (timeframe for NCT03640312)
status: Active
Definitions
- Concept
* All-cause mortality
handling: boolean variable
Timings
- Text
* 12 weeks

Generated Narrative: EvidenceVariable #NCT03640312-SeriousAdverseEvents

Profile: VariableDefinition
title: Serious Adverse Events (timeframe for NCT03640312)
status: Active
Definitions
- Concept
* Serious Adverse Events
handling: boolean variable
Timings
- Text
* 12 weeks

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvents

Profile: VariableDefinition
title: Other Adverse Events (timeframe for NCT03640312)
status: Active
Definitions
- Concept
* Other Adverse Events
handling: boolean variable
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-AllCauseMortality-EG000

Profile: NonComparativeEvidence
name: NCT03640312_AllCauseMortality_EG000
title: All-cause mortality for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable All-cause mortality (timeframe for NCT03640312)
statistic
statisticType: Percentage
quantity: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-SeriousAdverseEvents-EG000

Profile: NonComparativeEvidence
name: NCT03640312_SeriousAdverseEvents_EG000
title: Serious Adverse Events for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Serious Adverse Events (timeframe for NCT03640312)
statistic
statisticType: Percentage
quantity: 0.0625
numberAffected: 2
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvents-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvents_EG000
title: Other Adverse Events for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Other Adverse Events (timeframe for NCT03640312)
statistic
statisticType: Percentage
quantity: 0.625
numberAffected: 20
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-AllCauseMortality-EG001

Profile: NonComparativeEvidence
name: NCT03640312_AllCauseMortality_EG001
title: All-cause mortality for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable All-cause mortality (timeframe for NCT03640312)
statistic
statisticType: Percentage
quantity: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 30

Generated Narrative: Evidence #NCT03640312-SeriousAdverseEvents-EG001

Profile: NonComparativeEvidence
name: NCT03640312_SeriousAdverseEvents_EG001
title: Serious Adverse Events for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Serious Adverse Events (timeframe for NCT03640312)
statistic
statisticType: Percentage
quantity: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 30

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvents-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvents_EG001
title: Other Adverse Events for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Other Adverse Events (timeframe for NCT03640312)
statistic
statisticType: Percentage
quantity: 0.4666666666666667
numberAffected: 14
SampleSizes
- KnownDataCount
* 30

Generated Narrative: Evidence #NCT03640312-SeriousAdverseEvent-0-EG000

Profile: NonComparativeEvidence
name: NCT03640312_SeriousAdverseEvent_0_EG000
title: Road Traffic Accident as serious adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Road Traffic Accident as serious adverse event
statistic
statisticType: Percentage
quantity: 0.03125
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-SeriousAdverseEvent-0-EG001

Profile: NonComparativeEvidence
name: NCT03640312_SeriousAdverseEvent_0_EG001
title: Road Traffic Accident as serious adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Road Traffic Accident as serious adverse event
statistic
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-SeriousAdverseEvent-0

Profile: VariableDefinition
title: Road Traffic Accident as serious adverse event
status: Active
note:
Motor Vehicle Accident. Severity: Severe. Outcome: Resolved with sequelae. Blinded relatedness assessment: Unrelated. Investigational product action taken: Temporarily Withdrawn. Resulted in hospitalization.

Definitions
- Concept
* Road Traffic Accident as serious adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Serious Adverse Event, Injury, poisoning and procedural complications
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-SeriousAdverseEvent-1-EG000

Profile: NonComparativeEvidence
name: NCT03640312_SeriousAdverseEvent_1_EG000
title: Chest Pain as serious adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Chest Pain as serious adverse event
statistic
statisticType: Percentage
quantity: 0.03125
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-SeriousAdverseEvent-1-EG001

Profile: NonComparativeEvidence
name: NCT03640312_SeriousAdverseEvent_1_EG001
title: Chest Pain as serious adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Chest Pain as serious adverse event
statistic
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-SeriousAdverseEvent-1

Profile: VariableDefinition
title: Chest Pain as serious adverse event
status: Active
note:
Severity: Severe. Outcome: Resolved with Sequelae. Relatedness Assessment: Unrelated. Investigational Product action taken: Temporarily Withdrawn. Resulted in hospitalization.

Definitions
- Concept
* Chest Pain as serious adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Serious Adverse Event, General disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-0-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_0_EG000
title: Vision blurred as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Vision blurred as other adverse event
statistic
statisticType: Percentage
quantity: 0.03125
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-0-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_0_EG001
title: Vision blurred as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Vision blurred as other adverse event
statistic
statisticType: Percentage
quantity: 0.03333333333333333
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-0

Profile: VariableDefinition
title: Vision blurred as other adverse event
status: Active
note:
2 Total events:

Severity: Mild. Outcome: Ongoing at study exit. Relatedness assessment: Unrelated. Investigational product action taken: None. Study arm: Candesartan

Severe, resolved without sequelae, unlikely related, no action taken, LDQT

Definitions
- Concept
* Vision blurred as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, Eye disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-1-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_1_EG000
title: Palpitations as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Palpitations as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-1-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_1_EG001
title: Palpitations as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Palpitations as other adverse event
statistic
statisticType: Percentage
quantity: 0.03333333333333333
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-1

Profile: VariableDefinition
title: Palpitations as other adverse event
status: Active
note:
Palpitations, mild, resolved without sequelae, possible relatedness, no IP action taken.

Definitions
- Concept
* Palpitations as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, Cardiac disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-2-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_2_EG000
title: Tinnitus as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Tinnitus as other adverse event
statistic
statisticType: Percentage
quantity: 0.03125
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-2-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_2_EG001
title: Tinnitus as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Tinnitus as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-2

Profile: VariableDefinition
title: Tinnitus as other adverse event
status: Active
note:
Ringing in ears, mild, ongoing at study exit, assessed unrelated, no IP action taken.

Definitions
- Concept
* Tinnitus as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, Ear and labyrinth disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-3-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_3_EG000
title: Eye pruritis as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Eye pruritis as other adverse event
statistic
statisticType: Percentage
quantity: 0.03125
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-3-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_3_EG001
title: Eye pruritis as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Eye pruritis as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-3

Profile: VariableDefinition
title: Eye pruritis as other adverse event
status: Active
note:
Itchy eyes, mild, resolved without sequelae, unlikely relatedness, no IP action taken

Definitions
- Concept
* Eye pruritis as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, Eye disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-4-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_4_EG000
title: Diarrhea as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Diarrhea as other adverse event
statistic
statisticType: Percentage
quantity: 0.09375
numberOfEvents: 3
numberAffected: 3
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-4-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_4_EG001
title: Diarrhea as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Diarrhea as other adverse event
statistic
statisticType: Percentage
quantity: 0.06666666666666667
numberOfEvents: 2
numberAffected: 2
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-4

Profile: VariableDefinition
title: Diarrhea as other adverse event
status: Active
note:
5 total events (2 control, 3 LDQT) Diarrhea, mild (5/5), resolved w/o sequelae (4/5) ongoing at study exit (1/5), unlikely (2/5) unrelated (3/5), no IP action taken (4/5) temporarily withdrawn (1/5).

Definitions
- Concept
* Diarrhea as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, Gastrointestinal disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-5-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_5_EG000
title: Abdominal pain upper as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Abdominal pain upper as other adverse event
statistic
statisticType: Percentage
quantity: 0.03125
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-5-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_5_EG001
title: Abdominal pain upper as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Abdominal pain upper as other adverse event
statistic
statisticType: Percentage
quantity: 0.06666666666666667
numberOfEvents: 2
numberAffected: 2
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-5

Profile: VariableDefinition
title: Abdominal pain upper as other adverse event
status: Active
note:
3 total Stomach cramping (1/3) stomach gas/pain (2/3), mild (3/3), resolved without sequelae (2/3) ongoing at study exit (1/3), unrelated (3/3), no IP action taken (1/3) temporarily withdrawn (1/3) permanently discontinued (1/3)

Definitions
- Concept
* Abdominal pain upper as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, Gastrointestinal disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-6-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_6_EG000
title: Dry Mouth as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Dry Mouth as other adverse event
statistic
statisticType: Percentage
quantity: 0.03125
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-6-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_6_EG001
title: Dry Mouth as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Dry Mouth as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-6

Profile: VariableDefinition
title: Dry Mouth as other adverse event
status: Active
note:
mild, resolved without sequelae, unrelated, no IP action taken

Definitions
- Concept
* Dry Mouth as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, Gastrointestinal disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-7-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_7_EG000
title: Constipation as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Constipation as other adverse event
statistic
statisticType: Percentage
quantity: 0.03125
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-7-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_7_EG001
title: Constipation as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Constipation as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-7

Profile: VariableDefinition
title: Constipation as other adverse event
status: Active
note:
mild, resolved without sequelae, unrelated, no IP action taken

Definitions
- Concept
* Constipation as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, Gastrointestinal disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-8-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_8_EG000
title: Throat irritation as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Throat irritation as other adverse event
statistic
statisticType: Percentage
quantity: 0.03125
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-8-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_8_EG001
title: Throat irritation as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Throat irritation as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-8

Profile: VariableDefinition
title: Throat irritation as other adverse event
status: Active
note:
mild, resolved without sequelae, possible relatedness, no IP action taken

Definitions
- Concept
* Throat irritation as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, Gastrointestinal disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-9-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_9_EG000
title: Nausea as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Nausea as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-9-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_9_EG001
title: Nausea as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Nausea as other adverse event
statistic
statisticType: Percentage
quantity: 0.03333333333333333
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-9

Profile: VariableDefinition
title: Nausea as other adverse event
status: Active
note:
Nausea/vomiting, mild, resolved without sequelae, possible relatedness, permanently discontinued

Definitions
- Concept
* Nausea as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, Gastrointestinal disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-10-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_10_EG000
title: Dry throat as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Dry throat as other adverse event
statistic
statisticType: Percentage
quantity: 0.03125
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-10-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_10_EG001
title: Dry throat as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Dry throat as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-10

Profile: VariableDefinition
title: Dry throat as other adverse event
status: Active
note:
mild, resolved without sequelae, possible relatedness, temporarily withdrawn

Definitions
- Concept
* Dry throat as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, Gastrointestinal disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-11-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_11_EG000
title: Vomiting as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Vomiting as other adverse event
statistic
statisticType: Percentage
quantity: 0.03125
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-11-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_11_EG001
title: Vomiting as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Vomiting as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-11

Profile: VariableDefinition
title: Vomiting as other adverse event
status: Active
note:
Nausea/Vomiting, mild, resolved without sequelae, unrelated, temporarily withdrawn

Definitions
- Concept
* Vomiting as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, Gastrointestinal disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-12-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_12_EG000
title: Feeling Hot as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Feeling Hot as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-12-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_12_EG001
title: Feeling Hot as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Feeling Hot as other adverse event
statistic
statisticType: Percentage
quantity: 0.03333333333333333
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-12

Profile: VariableDefinition
title: Feeling Hot as other adverse event
status: Active
note:
Feeling warm, moderate, resolved without sequelae, possible relatedness, permanently discontinued

Definitions
- Concept
* Feeling Hot as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, General disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-13-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_13_EG000
title: Influenza like illness as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Influenza like illness as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-13-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_13_EG001
title: Influenza like illness as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Influenza like illness as other adverse event
statistic
statisticType: Percentage
quantity: 0.03333333333333333
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-13

Profile: VariableDefinition
title: Influenza like illness as other adverse event
status: Active
note:
Flu-like symptoms, moderate, ongoing at study exit, unrelated, no IP action taken

Definitions
- Concept
* Influenza like illness as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, General disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-14-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_14_EG000
title: Fatigue as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Fatigue as other adverse event
statistic
statisticType: Percentage
quantity: 0.0625
numberOfEvents: 3
numberAffected: 2
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-14-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_14_EG001
title: Fatigue as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Fatigue as other adverse event
statistic
statisticType: Percentage
quantity: 0.03333333333333333
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-14

Profile: VariableDefinition
title: Fatigue as other adverse event
status: Active
note:
4 total mild (4/4), resolved without sequelae (4/4), unrelated (1/4) unlikely (2/4), possible (1/4), no IP action taken (4/4)

Definitions
- Concept
* Fatigue as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, General disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-15-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_15_EG000
title: Peripheral swelling as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Peripheral swelling as other adverse event
statistic
statisticType: Percentage
quantity: 0.03125
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-15-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_15_EG001
title: Peripheral swelling as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Peripheral swelling as other adverse event
statistic
statisticType: Percentage
quantity: 0.1
numberOfEvents: 3
numberAffected: 3
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-15

Profile: VariableDefinition
title: Peripheral swelling as other adverse event
status: Active
note:
4 total Swelling of legs/ankles (2/4) swelling of hands/feet (2/4), mild (4/4), resolved without sequelae (3/4) ongoing at study exit (1/4), unrelated (2/4) possible (2/4), no IP action taken (3/4) permanently discontinued (1/4)

Definitions
- Concept
* Peripheral swelling as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, General disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-16-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_16_EG000
title: Chest Pain as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Chest Pain as other adverse event
statistic
statisticType: Percentage
quantity: 0.03125
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-16-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_16_EG001
title: Chest Pain as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Chest Pain as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-16

Profile: VariableDefinition
title: Chest Pain as other adverse event
status: Active
note:
mild, resolved without sequelae, unrelated, no IP action taken

Definitions
- Concept
* Chest Pain as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, General disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-17-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_17_EG000
title: Asthenia as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Asthenia as other adverse event
statistic
statisticType: Percentage
quantity: 0.03125
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-17-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_17_EG001
title: Asthenia as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Asthenia as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-17

Profile: VariableDefinition
title: Asthenia as other adverse event
status: Active
note:
mild, resolved without sequelae, possible relatedness, temporarily withdrawn

Definitions
- Concept
* Asthenia as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, General disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-18-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_18_EG000
title: Pain as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Pain as other adverse event
statistic
statisticType: Percentage
quantity: 0.03125
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-18-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_18_EG001
title: Pain as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Pain as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-18

Profile: VariableDefinition
title: Pain as other adverse event
status: Active
note:
Body aches, mild, resolved without sequelae, unrelated, temporarily withdrawn

Definitions
- Concept
* Pain as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, General disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-19-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_19_EG000
title: Blood glucose increased as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Blood glucose increased as other adverse event
statistic
statisticType: Percentage
quantity: 0.03125
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-19-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_19_EG001
title: Blood glucose increased as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Blood glucose increased as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-19

Profile: VariableDefinition
title: Blood glucose increased as other adverse event
status: Active
note:
Elevated blood sugar, mild, ongoing at study exit, unlikely relatedness, no IP action taken

Definitions
- Concept
* Blood glucose increased as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, Investigations
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-20-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_20_EG000
title: Heart rate irregular as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Heart rate irregular as other adverse event
statistic
statisticType: Percentage
quantity: 0.0625
numberOfEvents: 2
numberAffected: 2
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-20-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_20_EG001
title: Heart rate irregular as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Heart rate irregular as other adverse event
statistic
statisticType: Percentage
quantity: 0.06666666666666667
numberOfEvents: 3
numberAffected: 2
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-20

Profile: VariableDefinition
title: Heart rate irregular as other adverse event
status: Active
note:
5 total irregular/fast heartbeat (5/5), mild (5/5), resolved without sequelae (4/5) ongoing at study exit (1/5), unrelated (2/5) unlikely (2/5) possible (1/5), no IP action taken (3/5) permanently discontinued (2/5)

Definitions
- Concept
* Heart rate irregular as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, Investigations
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-21-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_21_EG000
title: Back pain as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Back pain as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-21-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_21_EG001
title: Back pain as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Back pain as other adverse event
statistic
statisticType: Percentage
quantity: 0.03333333333333333
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-21

Profile: VariableDefinition
title: Back pain as other adverse event
status: Active
note:
mild, ongoing at study exit, unlikely relatedness, no IP action taken

Definitions
- Concept
* Back pain as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, Musculoskeletal and connective tissue disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-22-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_22_EG000
title: Muscle cramps/spasms as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Muscle cramps/spasms as other adverse event
statistic
statisticType: Percentage
quantity: 0.03125
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-22-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_22_EG001
title: Muscle cramps/spasms as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Muscle cramps/spasms as other adverse event
statistic
statisticType: Percentage
quantity: 0.03333333333333333
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-22

Profile: VariableDefinition
title: Muscle cramps/spasms as other adverse event
status: Active
note:
2 total mild (1/2) severe (1/2), resolved without sequelae (2/2), unrelated (1/2) unlikely (1/2), no IP action taken (2/2)

Definitions
- Concept
* Muscle cramps/spasms as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, Musculoskeletal and connective tissue disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-23-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_23_EG000
title: Headache as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Headache as other adverse event
statistic
statisticType: Percentage
quantity: 0.15625
numberOfEvents: 6
numberAffected: 5
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-23-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_23_EG001
title: Headache as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Headache as other adverse event
statistic
statisticType: Percentage
quantity: 0.06666666666666667
numberOfEvents: 2
numberAffected: 2
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-23

Profile: VariableDefinition
title: Headache as other adverse event
status: Active
note:
8 total mild (8/8), resolved without sequelae (7/8) ongoing at study exit (1/8), unrelated (4/8) unlikely (3/8) possible (1/8), no IP action taken (6/8) permanently discontinued (2/8)

Definitions
- Concept
* Headache as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, Nervous system disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-24-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_24_EG000
title: Dizziness as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Dizziness as other adverse event
statistic
statisticType: Percentage
quantity: 0.0625
numberOfEvents: 2
numberAffected: 2
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-24-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_24_EG001
title: Dizziness as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Dizziness as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-24

Profile: VariableDefinition
title: Dizziness as other adverse event
status: Active
note:
2 total mild (2/2), resolved without sequelae (2/2), possible relatedness (2/2), no IP action taken (2/2)

Definitions
- Concept
* Dizziness as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, Nervous system disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-25-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_25_EG000
title: Vision blurred as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Vision blurred as other adverse event
statistic
statisticType: Percentage
quantity: 0.03125
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-25-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_25_EG001
title: Vision blurred as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Vision blurred as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-25

Profile: VariableDefinition
title: Vision blurred as other adverse event
status: Active
note:
Blurred vision/vision or hearing changes, mild, resolved without sequelae, unlikely relatedness, permanently discontinued

Definitions
- Concept
* Vision blurred as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, Nervous system disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-26-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_26_EG000
title: Hypoaesthesia as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Hypoaesthesia as other adverse event
statistic
statisticType: Percentage
quantity: 0.03125
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-26-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_26_EG001
title: Hypoaesthesia as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Hypoaesthesia as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-26

Profile: VariableDefinition
title: Hypoaesthesia as other adverse event
status: Active
note:
cold/tingling/numb hands/feet, mild, resolved without sequelae, unrelated, no IP action taken

Definitions
- Concept
* Hypoaesthesia as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, Nervous system disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-27-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_27_EG000
title: Anxiety as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Anxiety as other adverse event
statistic
statisticType: Percentage
quantity: 0.0625
numberOfEvents: 2
numberAffected: 2
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-27-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_27_EG001
title: Anxiety as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Anxiety as other adverse event
statistic
statisticType: Percentage
quantity: 0.03333333333333333
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-27

Profile: VariableDefinition
title: Anxiety as other adverse event
status: Active
note:
3 total mild (3/3), resolved without sequelae (1/3) resolved with sequelae (1/3) ongoing at study exit (1/3), unrelated (2/3) possible (1/3), no IP action taken (3/3)

Definitions
- Concept
* Anxiety as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, Psychiatric disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-28-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_28_EG000
title: Nasopharyngitis as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Nasopharyngitis as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-28-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_28_EG001
title: Nasopharyngitis as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Nasopharyngitis as other adverse event
statistic
statisticType: Percentage
quantity: 0.03333333333333333
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-28

Profile: VariableDefinition
title: Nasopharyngitis as other adverse event
status: Active
note:
Cold symptoms, mild, ongoing at study exit, unrelated, no IP action taken

Definitions
- Concept
* Nasopharyngitis as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, Respiratory, thoracic and mediastinal disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-29-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_29_EG000
title: Cough as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Cough as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-29-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_29_EG001
title: Cough as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Cough as other adverse event
statistic
statisticType: Percentage
quantity: 0.1
numberOfEvents: 3
numberAffected: 3
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-29

Profile: VariableDefinition
title: Cough as other adverse event
status: Active
note:
3 total mild (3/3), resolved without sequelae (1/3) resolved with sequelae (1/3) ongoing at study exit (1/3), unrelated (2/3) unlikely (1/3), no IP action taken (3/3)

Definitions
- Concept
* Cough as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, Respiratory, thoracic and mediastinal disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-30-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_30_EG000
title: Dyspnea as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Dyspnea as other adverse event
statistic
statisticType: Percentage
quantity: 0.09375
numberOfEvents: 4
numberAffected: 3
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-30-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_30_EG001
title: Dyspnea as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Dyspnea as other adverse event
statistic
statisticType: Percentage
quantity: 0.06666666666666667
numberOfEvents: 2
numberAffected: 2
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-30

Profile: VariableDefinition
title: Dyspnea as other adverse event
status: Active
note:
6 total Breathing problems (6/6), mild (5/6) moderate (1/6), resolved without sequelae (3/6) resolved with sequelae (2/6) ongoing at study exit (1/6), unrelated (4/6) unlikely (2/6), no IP action taken (5/6) temporarily withdrawn (1/6)

Definitions
- Concept
* Dyspnea as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, Respiratory, thoracic and mediastinal disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-31-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_31_EG000
title: Respiration Abnormal as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Respiration Abnormal as other adverse event
statistic
statisticType: Percentage
quantity: 0.03125
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-31-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_31_EG001
title: Respiration Abnormal as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Respiration Abnormal as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-31

Profile: VariableDefinition
title: Respiration Abnormal as other adverse event
status: Active
note:
Breathing problem, severe, resolved without sequelae, unlikely relatedness, no IP action taken

Definitions
- Concept
* Respiration Abnormal as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, Respiratory, thoracic and mediastinal disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-32-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_32_EG000
title: Hyperhidrosis as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Hyperhidrosis as other adverse event
statistic
statisticType: Percentage
quantity: 0.03125
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-32-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_32_EG001
title: Hyperhidrosis as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Hyperhidrosis as other adverse event
statistic
statisticType: Percentage
quantity: 0.03333333333333333
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-32

Profile: VariableDefinition
title: Hyperhidrosis as other adverse event
status: Active
note:
2 total Sweating (2/2), mild (2/2), resolved without sequelae (2/2), unrealted (2/2), no IP action taken (1/2) permanently discontinued (1/2)

Definitions
- Concept
* Hyperhidrosis as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, Skin and subcutaneous tissue disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-33-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_33_EG000
title: Rash as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Rash as other adverse event
statistic
statisticType: Percentage
quantity: 0.03125
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-33-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_33_EG001
title: Rash as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Rash as other adverse event
statistic
statisticType: Percentage
quantity: 0
numberOfEvents: 0
numberAffected: 0
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-33

Profile: VariableDefinition
title: Rash as other adverse event
status: Active
note:
Rash, mild, resolved without sequelae, unlikely relatedness, no IP action taken

Definitions
- Concept
* Rash as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, Skin and subcutaneous tissue disorders
Timings
- Text
* 12 weeks

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-34-EG000

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_34_EG000
title: Dizziness as other adverse event for QUARTET LDQT in NCT03640312
status: Active
variableDefinition
description:
QUARTET LDQT

variableRole: Population
observed: Patients randomized to the intervention arm will take 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.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Dizziness as other adverse event
statistic
statisticType: Percentage
quantity: 0.125
numberOfEvents: 4
numberAffected: 4
SampleSizes
- KnownDataCount
* 32

Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-34-EG001

Profile: NonComparativeEvidence
name: NCT03640312_OtherAdverseEvent_34_EG001
title: Dizziness as other adverse event for Candesartan in NCT03640312
status: Active
variableDefinition
description:
Candesartan

variableRole: Population
observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
variableDefinition
note:
Same as clinicaltrials.gov definition.

A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database.

variableRole: Outcome
observed: EvidenceVariable Dizziness as other adverse event
statistic
statisticType: Percentage
quantity: 0.03333333333333333
numberOfEvents: 1
numberAffected: 1
SampleSizes
- KnownDataCount
* 30

Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-34

Profile: VariableDefinition
title: Dizziness as other adverse event
status: Active
note:
5 total Feeling faint/lightheadedness/falling (5/5), mild (4/5) moderate (1/5), resolved without sequelae (5/5), unlikely relatedness (2/5) possible (3/5), no IP action taken (5/5)

Definitions
- Concept
* Dizziness as other adverse event
definitionModifier
code: Adverse event assessment type
value: Systematic Assessment
definitionModifier
code: Source Vocabulary for Adverse Event Definition
value: MedDRA 23.0
handling: boolean variable
classifier: Other Adverse Event, Vascular disorders
Timings
- Text
* 12 weeks