http://hl7.org/fhir/uv/ebm/Composition/370505
type: Composition
node role: treeRoot
id:
  v: 370505
meta:
  version id:
    v: 25
  last updated:
    v: 2025-08-18T13:22:42.074Z
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/outcome-measure-report
    l: outcome-measure-report
language:
  v: en
text:
  status:
    v: extensions
  div:
    v: Generated Narrative: Composition 370505 version: 25; Last updated: 2025-08-18 13:22:42+0000; Language: en 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/resources/Composition/370505. 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: Populatio…
contained: EvidenceVariable
  id:
    v: NCT03640312-AllCauseMortality
  meta:
    profile:
      v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
      l: variable-definition
  title:
    v: All-cause mortality (timeframe for NCT03640312)
  status:
    v: active
  definition:
    concept:
      text:
        v: All-cause mortality
  handling:
    v: boolean
  timing:
    text:
      v: 12 weeks
contained: EvidenceVariable
  id:
    v: NCT03640312-SeriousAdverseEvents
  meta:
    profile:
      v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
      l: variable-definition
  title:
    v: Serious Adverse Events (timeframe for NCT03640312)
  status:
    v: active
  definition:
    concept:
      text:
        v: Serious Adverse Events
  handling:
    v: boolean
  timing:
    text:
      v: 12 weeks
contained: EvidenceVariable
  id:
    v: NCT03640312-OtherAdverseEvents
  meta:
    profile:
      v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
      l: variable-definition
  title:
    v: Other Adverse Events (timeframe for NCT03640312)
  status:
    v: active
  definition:
    concept:
      text:
        v: Other Adverse Events
  handling:
    v: boolean
  timing:
    text:
      v: 12 weeks
contained: Evidence
  id:
    v: NCT03640312-AllCauseMortality-EG000
  meta:
    profile:
      v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
      l: non-comparative-evidence
  name:
    v: NCT03640312_AllCauseMortality_EG000
  title:
    v: All-cause mortality for QUARTET LDQT in NCT03640312
  status:
    v: active
  variable definition:
    description:
      v: QUARTET LDQT
    variable role:
      v: population
    observed:
      display:
        v: 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.
  variable definition:
    note:
      text:
        v: 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.
    variable role:
      v: outcome
    observed:
      l: NCT03640312-AllCauseMortality
      reference:
        v: #NCT03640312-AllCauseMortality
      type:
        v: EvidenceVariable
        l: EvidenceVariable
  statistic:
    statistic type:
      text:
        v: Percentage
    quantity:
      value:
        v: 0
    number affected:
      v: 0
    sample size:
      known data count:
        v: 32
contained: Evidence
  id:
    v: NCT03640312-SeriousAdverseEvents-EG000
  meta:
    profile:
      v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
      l: non-comparative-evidence
  name:
    v: NCT03640312_SeriousAdverseEvents_EG000
  title:
    v: Serious Adverse Events for QUARTET LDQT in NCT03640312
  status:
    v: active
  variable definition:
    description:
      v: QUARTET LDQT
    variable role:
      v: population
    observed:
      display:
        v: 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.
  variable definition:
    note:
      text:
        v: 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.
    variable role:
      v: outcome
    observed:
      l: NCT03640312-SeriousAdverseEvents
      reference:
        v: #NCT03640312-SeriousAdverseEvents
      type:
        v: EvidenceVariable
        l: EvidenceVariable
  statistic:
    statistic type:
      text:
        v: Percentage
    quantity:
      value:
        v: 0.0625
    number affected:
      v: 2
    sample size:
      known data count:
        v: 32
contained: Evidence
  id:
    v: NCT03640312-OtherAdverseEvents-EG000
  meta:
    profile:
      v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
      l: non-comparative-evidence
  name:
    v: NCT03640312_OtherAdverseEvents_EG000
  title:
    v: Other Adverse Events for QUARTET LDQT in NCT03640312
  status:
    v: active
  variable definition:
    description:
      v: QUARTET LDQT
    variable role:
      v: population
    observed:
      display:
        v: 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.
  variable definition:
    note:
      text:
        v: 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.
    variable role:
      v: outcome
    observed:
      l: NCT03640312-OtherAdverseEvents
      reference:
        v: #NCT03640312-OtherAdverseEvents
      type:
        v: EvidenceVariable
        l: EvidenceVariable

statistic type:
  text:
    v: Percentage
quantity:
  value:
    v: 0.625
number affected:
  v: 20
sample size:
  known data count:
    v: 32

Evidence
id:
  v: NCT03640312-AllCauseMortality-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_AllCauseMortality_EG001
title:
  v: All-cause mortality for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-AllCauseMortality
    reference:
      v: #NCT03640312-AllCauseMortality
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 30

Evidence
id:
  v: NCT03640312-SeriousAdverseEvents-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_SeriousAdverseEvents_EG001
title:
  v: Serious Adverse Events for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-SeriousAdverseEvents
    reference:
      v: #NCT03640312-SeriousAdverseEvents
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 30

Evidence
id:
  v: NCT03640312-OtherAdverseEvents-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvents_EG001
title:
  v: Other Adverse Events for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvents
    reference:
      v: #NCT03640312-OtherAdverseEvents
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.4666666666666667
  number affected:
    v: 14
  sample size:
    known data count:
      v: 30

Evidence
id:
  v: NCT03640312-SeriousAdverseEvent-0-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_SeriousAdverseEvent_0_EG000
title:
  v: Road Traffic Accident as serious adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-SeriousAdverseEvent-0
    reference:
      v: #NCT03640312-SeriousAdverseEvent-0
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03125
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-SeriousAdverseEvent-0-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_SeriousAdverseEvent_0_EG001
title:
  v: Road Traffic Accident as serious adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-SeriousAdverseEvent-0
    reference:
      v: #NCT03640312-SeriousAdverseEvent-0
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-SeriousAdverseEvent-0
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Road Traffic Accident as serious adverse event
status:
  v: active
note:
  text:
    v: Motor Vehicle Accident. Severity: Severe. Outcome: Resolved with sequelae. Blinded relatedness assessment: Unrelated. Investigational product action taken: Temporarily Withdrawn. Resulted in hospitalization.
definition:
  concept:
    text:
      v: Road Traffic Accident as serious adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Serious Adverse Event
classifier:
  text:
    v: Injury, poisoning and procedural complications
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-SeriousAdverseEvent-1-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_SeriousAdverseEvent_1_EG000
title:
  v: Chest Pain as serious adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-SeriousAdverseEvent-1
    reference:
      v: #NCT03640312-SeriousAdverseEvent-1
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03125
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-SeriousAdverseEvent-1-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_SeriousAdverseEvent_1_EG001
title:
  v: Chest Pain as serious adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-SeriousAdverseEvent-1
    reference:
      v: #NCT03640312-SeriousAdverseEvent-1
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-SeriousAdverseEvent-1
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Chest Pain as serious adverse event
status:
  v: active
note:
  text:
    v: Severity: Severe. Outcome: Resolved with Sequelae. Relatedness Assessment: Unrelated. Investigational Product action taken: Temporarily Withdrawn. Resulted in hospitalization.
definition:
  concept:
    text:
      v: Chest Pain as serious adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Serious Adverse Event
classifier:
  text:
    v: General disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-0-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_0_EG000
title:
  v: Vision blurred as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-0
    reference:
      v: #NCT03640312-OtherAdverseEvent-0
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03125
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-0-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_0_EG001
title:
  v: Vision blurred as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-0
    reference:
      v: #NCT03640312-OtherAdverseEvent-0
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03333333333333333
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-0
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Vision blurred as other adverse event
status:
  v: active
note:
  text:
    v: 2 Total events: 1. Severity: Mild. Outcome: Ongoing at study exit. Relatedness assessment: Unrelated. Investigational product action taken: None. Study arm: Candesartan 2. Severe, resolved without sequelae, unlikely related, no action taken, LDQT
definition:
  concept:
    text:
      v: Vision blurred as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Eye disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-1-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_1_EG000
title:
  v: Palpitations as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-1
    reference:
      v: #NCT03640312-OtherAdverseEvent-1
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-1-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_1_EG001
title:
  v: Palpitations as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-1
    reference:
      v: #NCT03640312-OtherAdverseEvent-1
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03333333333333333
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-1
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Palpitations as other adverse event
status:
  v: active
note:
  text:
    v: Palpitations, mild, resolved without sequelae, possible relatedness, no IP action taken.
definition:
  concept:
    text:
      v: Palpitations as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Cardiac disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-2-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_2_EG000
title:
  v: Tinnitus as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-2
    reference:
      v: #NCT03640312-OtherAdverseEvent-2
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03125
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-2-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_2_EG001
title:
  v: Tinnitus as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-2
    reference:
      v: #NCT03640312-OtherAdverseEvent-2
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-2
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Tinnitus as other adverse event
status:
  v: active
note:
  text:
    v: Ringing in ears, mild, ongoing at study exit, assessed unrelated, no IP action taken.
definition:
  concept:
    text:
      v: Tinnitus as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Ear and labyrinth disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-3-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_3_EG000
title:
  v: Eye pruritis as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-3
    reference:
      v: #NCT03640312-OtherAdverseEvent-3
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03125
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-3-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_3_EG001
title:
  v: Eye pruritis as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-3
    reference:
      v: #NCT03640312-OtherAdverseEvent-3
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-3
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Eye pruritis as other adverse event
status:
  v: active
note:
  text:
    v: Itchy eyes, mild, resolved without sequelae, unlikely relatedness, no IP action taken
definition:
  concept:
    text:
      v: Eye pruritis as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Eye disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-4-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_4_EG000
title:
  v: Diarrhea as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-4
    reference:
      v: #NCT03640312-OtherAdverseEvent-4
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.09375
  number of events:
    v: 3
  number affected:
    v: 3
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-4-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_4_EG001
title:
  v: Diarrhea as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-4
    reference:
      v: #NCT03640312-OtherAdverseEvent-4
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.06666666666666667
  number of events:
    v: 2
  number affected:
    v: 2
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-4
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Diarrhea as other adverse event
status:
  v: active
note:
  text:
    v: 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).
definition:
  concept:
    text:
      v: Diarrhea as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Gastrointestinal disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-5-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_5_EG000
title:
  v: Abdominal pain upper as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-5
    reference:
      v: #NCT03640312-OtherAdverseEvent-5
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03125
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-5-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_5_EG001
title:
  v: Abdominal pain upper as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-5
    reference:
      v: #NCT03640312-OtherAdverseEvent-5
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.06666666666666667
  number of events:
    v: 2
  number affected:
    v: 2
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-5
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Abdominal pain upper as other adverse event
status:
  v: active
note:
  text:
    v: 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)
definition:
  concept:
    text:
      v: Abdominal pain upper as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Gastrointestinal disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-6-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_6_EG000
title:
  v: Dry Mouth as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-6
    reference:
      v: #NCT03640312-OtherAdverseEvent-6
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03125
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-6-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_6_EG001
title:
  v: Dry Mouth as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-6
    reference:
      v: #NCT03640312-OtherAdverseEvent-6
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-6
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Dry Mouth as other adverse event
status:
  v: active
note:
  text:
    v: mild, resolved without sequelae, unrelated, no IP action taken
definition:
  concept:
    text:
      v: Dry Mouth as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Gastrointestinal disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-7-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_7_EG000
title:
  v: Constipation as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-7
    reference:
      v: #NCT03640312-OtherAdverseEvent-7
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03125
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-7-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_7_EG001
title:
  v: Constipation as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-7
    reference:
      v: #NCT03640312-OtherAdverseEvent-7
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-7
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Constipation as other adverse event
status:
  v: active
note:
  text:
    v: mild, resolved without sequelae, unrelated, no IP action taken
definition:
  concept:
    text:
      v: Constipation as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Gastrointestinal disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-8-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_8_EG000
title:
  v: Throat irritation as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-8
    reference:
      v: #NCT03640312-OtherAdverseEvent-8
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03125
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-8-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_8_EG001
title:
  v: Throat irritation as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-8
    reference:
      v: #NCT03640312-OtherAdverseEvent-8
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-8
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Throat irritation as other adverse event
status:
  v: active
note:
  text:
    v: mild, resolved without sequelae, possible relatedness, no IP action taken
definition:
  concept:
    text:
      v: Throat irritation as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Gastrointestinal disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-9-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_9_EG000
title:
  v: Nausea as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-9
    reference:
      v: #NCT03640312-OtherAdverseEvent-9
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-9-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_9_EG001
title:
  v: Nausea as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-9
    reference:
      v: #NCT03640312-OtherAdverseEvent-9
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03333333333333333
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-9
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Nausea as other adverse event
status:
  v: active
note:
  text:
    v: Nausea/vomiting, mild, resolved without sequelae, possible relatedness, permanently discontinued
definition:
  concept:
    text:
      v: Nausea as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Gastrointestinal disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-10-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_10_EG000
title:
  v: Dry throat as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-10
    reference:
      v: #NCT03640312-OtherAdverseEvent-10
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03125
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-10-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_10_EG001
title:
  v: Dry throat as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-10
    reference:
      v: #NCT03640312-OtherAdverseEvent-10
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-10
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Dry throat as other adverse event
status:
  v: active
note:
  text:
    v: mild, resolved without sequelae, possible relatedness, temporarily withdrawn
definition:
  concept:
    text:
      v: Dry throat as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Gastrointestinal disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-11-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_11_EG000
title:
  v: Vomiting as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-11
    reference:
      v: #NCT03640312-OtherAdverseEvent-11
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03125
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-11-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_11_EG001
title:
  v: Vomiting as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-11
    reference:
      v: #NCT03640312-OtherAdverseEvent-11
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-11
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Vomiting as other adverse event
status:
  v: active
note:
  text:
    v: Nausea/Vomiting, mild, resolved without sequelae, unrelated, temporarily withdrawn
definition:
  concept:
    text:
      v: Vomiting as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Gastrointestinal disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-12-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_12_EG000
title:
  v: Feeling Hot as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-12
    reference:
      v: #NCT03640312-OtherAdverseEvent-12
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-12-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_12_EG001
title:
  v: Feeling Hot as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-12
    reference:
      v: #NCT03640312-OtherAdverseEvent-12
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03333333333333333
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-12
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Feeling Hot as other adverse event
status:
  v: active
note:
  text:
    v: Feeling warm, moderate, resolved without sequelae, possible relatedness, permanently discontinued
definition:
  concept:
    text:
      v: Feeling Hot as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: General disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-13-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_13_EG000
title:
  v: Influenza like illness as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-13
    reference:
      v: #NCT03640312-OtherAdverseEvent-13
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-13-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_13_EG001
title:
  v: Influenza like illness as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-13
    reference:
      v: #NCT03640312-OtherAdverseEvent-13
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03333333333333333
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-13
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Influenza like illness as other adverse event
status:
  v: active
note:
  text:
    v: Flu-like symptoms, moderate, ongoing at study exit, unrelated, no IP action taken
definition:
  concept:
    text:
      v: Influenza like illness as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: General disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-14-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_14_EG000
title:
  v: Fatigue as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-14
    reference:
      v: #NCT03640312-OtherAdverseEvent-14
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.0625
  number of events:
    v: 3
  number affected:
    v: 2
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-14-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_14_EG001
title:
  v: Fatigue as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-14
    reference:
      v: #NCT03640312-OtherAdverseEvent-14
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03333333333333333
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-14
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Fatigue as other adverse event
status:
  v: active
note:
  text:
    v: 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)
definition:
  concept:
    text:
      v: Fatigue as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: General disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-15-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_15_EG000
title:
  v: Peripheral swelling as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-15
    reference:
      v: #NCT03640312-OtherAdverseEvent-15
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03125
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-15-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_15_EG001
title:
  v: Peripheral swelling as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-15
    reference:
      v: #NCT03640312-OtherAdverseEvent-15
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.1
  number of events:
    v: 3
  number affected:
    v: 3
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-15
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Peripheral swelling as other adverse event
status:
  v: active
note:
  text:
    v: 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)
definition:
  concept:
    text:
      v: Peripheral swelling as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: General disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-16-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_16_EG000
title:
  v: Chest Pain as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-16
    reference:
      v: #NCT03640312-OtherAdverseEvent-16
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03125
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-16-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_16_EG001
title:
  v: Chest Pain as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-16
    reference:
      v: #NCT03640312-OtherAdverseEvent-16
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-16
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Chest Pain as other adverse event
status:
  v: active
note:
  text:
    v: mild, resolved without sequelae, unrelated, no IP action taken
definition:
  concept:
    text:
      v: Chest Pain as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: General disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-17-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_17_EG000
title:
  v: Asthenia as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-17
    reference:
      v: #NCT03640312-OtherAdverseEvent-17
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03125
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-17-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_17_EG001
title:
  v: Asthenia as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-17
    reference:
      v: #NCT03640312-OtherAdverseEvent-17
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-17
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Asthenia as other adverse event
status:
  v: active
note:
  text:
    v: mild, resolved without sequelae, possible relatedness, temporarily withdrawn
definition:
  concept:
    text:
      v: Asthenia as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: General disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-18-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_18_EG000
title:
  v: Pain as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-18
    reference:
      v: #NCT03640312-OtherAdverseEvent-18
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03125
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-18-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_18_EG001
title:
  v: Pain as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-18
    reference:
      v: #NCT03640312-OtherAdverseEvent-18
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-18
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Pain as other adverse event
status:
  v: active
note:
  text:
    v: Body aches, mild, resolved without sequelae, unrelated, temporarily withdrawn
definition:
  concept:
    text:
      v: Pain as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: General disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-19-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_19_EG000
title:
  v: Blood glucose increased as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-19
    reference:
      v: #NCT03640312-OtherAdverseEvent-19
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03125
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-19-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_19_EG001
title:
  v: Blood glucose increased as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-19
    reference:
      v: #NCT03640312-OtherAdverseEvent-19
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-19
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Blood glucose increased as other adverse event
status:
  v: active
note:
  text:
    v: Elevated blood sugar, mild, ongoing at study exit, unlikely relatedness, no IP action taken
definition:
  concept:
    text:
      v: Blood glucose increased as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Investigations
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-20-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_20_EG000
title:
  v: Heart rate irregular as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-20
    reference:
      v: #NCT03640312-OtherAdverseEvent-20
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.0625
  number of events:
    v: 2
  number affected:
    v: 2
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-20-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_20_EG001
title:
  v: Heart rate irregular as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-20
    reference:
      v: #NCT03640312-OtherAdverseEvent-20
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.06666666666666667
  number of events:
    v: 3
  number affected:
    v: 2
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-20
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Heart rate irregular as other adverse event
status:
  v: active
note:
  text:
    v: 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)
definition:
  concept:
    text:
      v: Heart rate irregular as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Investigations
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-21-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_21_EG000
title:
  v: Back pain as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-21
    reference:
      v: #NCT03640312-OtherAdverseEvent-21
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-21-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_21_EG001
title:
  v: Back pain as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-21
    reference:
      v: #NCT03640312-OtherAdverseEvent-21
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03333333333333333
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-21
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Back pain as other adverse event
status:
  v: active
note:
  text:
    v: mild, ongoing at study exit, unlikely relatedness, no IP action taken
definition:
  concept:
    text:
      v: Back pain as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Musculoskeletal and connective tissue disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-22-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_22_EG000
title:
  v: Muscle cramps/spasms as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-22
    reference:
      v: #NCT03640312-OtherAdverseEvent-22
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03125
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-22-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_22_EG001
title:
  v: Muscle cramps/spasms as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-22
    reference:
      v: #NCT03640312-OtherAdverseEvent-22
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03333333333333333
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-22
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Muscle cramps/spasms as other adverse event
status:
  v: active
note:
  text:
    v: 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)
definition:
  concept:
    text:
      v: Muscle cramps/spasms as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Musculoskeletal and connective tissue disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-23-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_23_EG000
title:
  v: Headache as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-23
    reference:
      v: #NCT03640312-OtherAdverseEvent-23
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.15625
  number of events:
    v: 6
  number affected:
    v: 5
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-23-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_23_EG001
title:
  v: Headache as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-23
    reference:
      v: #NCT03640312-OtherAdverseEvent-23
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.06666666666666667
  number of events:
    v: 2
  number affected:
    v: 2
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-23
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Headache as other adverse event
status:
  v: active
note:
  text:
    v: 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)
definition:
  concept:
    text:
      v: Headache as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Nervous system disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-24-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_24_EG000
title:
  v: Dizziness as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-24
    reference:
      v: #NCT03640312-OtherAdverseEvent-24
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.0625
  number of events:
    v: 2
  number affected:
    v: 2
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-24-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_24_EG001
title:
  v: Dizziness as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-24
    reference:
      v: #NCT03640312-OtherAdverseEvent-24
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-24
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Dizziness as other adverse event
status:
  v: active
note:
  text:
    v: 2 total mild (2/2), resolved without sequelae (2/2), possible relatedness (2/2), no IP action taken (2/2)
definition:
  concept:
    text:
      v: Dizziness as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Nervous system disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-25-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_25_EG000
title:
  v: Vision blurred as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-25
    reference:
      v: #NCT03640312-OtherAdverseEvent-25
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03125
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-25-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_25_EG001
title:
  v: Vision blurred as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-25
    reference:
      v: #NCT03640312-OtherAdverseEvent-25
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-25
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Vision blurred as other adverse event
status:
  v: active
note:
  text:
    v: Blurred vision/vision or hearing changes, mild, resolved without sequelae, unlikely relatedness, permanently discontinued
definition:
  concept:
    text:
      v: Vision blurred as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Nervous system disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-26-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_26_EG000
title:
  v: Hypoaesthesia as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-26
    reference:
      v: #NCT03640312-OtherAdverseEvent-26
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03125
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-26-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_26_EG001
title:
  v: Hypoaesthesia as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-26
    reference:
      v: #NCT03640312-OtherAdverseEvent-26
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-26
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Hypoaesthesia as other adverse event
status:
  v: active
note:
  text:
    v: cold/tingling/numb hands/feet, mild, resolved without sequelae, unrelated, no IP action taken
definition:
  concept:
    text:
      v: Hypoaesthesia as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Nervous system disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-27-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_27_EG000
title:
  v: Anxiety as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-27
    reference:
      v: #NCT03640312-OtherAdverseEvent-27
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.0625
  number of events:
    v: 2
  number affected:
    v: 2
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-27-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_27_EG001
title:
  v: Anxiety as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-27
    reference:
      v: #NCT03640312-OtherAdverseEvent-27
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03333333333333333
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-27
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Anxiety as other adverse event
status:
  v: active
note:
  text:
    v: 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)
definition:
  concept:
    text:
      v: Anxiety as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Psychiatric disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-28-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_28_EG000
title:
  v: Nasopharyngitis as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-28
    reference:
      v: #NCT03640312-OtherAdverseEvent-28
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-28-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_28_EG001
title:
  v: Nasopharyngitis as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-28
    reference:
      v: #NCT03640312-OtherAdverseEvent-28
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03333333333333333
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-28
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Nasopharyngitis as other adverse event
status:
  v: active
note:
  text:
    v: Cold symptoms, mild, ongoing at study exit, unrelated, no IP action taken
definition:
  concept:
    text:
      v: Nasopharyngitis as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Respiratory, thoracic and mediastinal disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-29-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_29_EG000
title:
  v: Cough as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-29
    reference:
      v: #NCT03640312-OtherAdverseEvent-29
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-29-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_29_EG001
title:
  v: Cough as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-29
    reference:
      v: #NCT03640312-OtherAdverseEvent-29
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.1
  number of events:
    v: 3
  number affected:
    v: 3
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-29
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Cough as other adverse event
status:
  v: active
note:
  text:
    v: 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)
definition:
  concept:
    text:
      v: Cough as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Respiratory, thoracic and mediastinal disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-30-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_30_EG000
title:
  v: Dyspnea as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-30
    reference:
      v: #NCT03640312-OtherAdverseEvent-30
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.09375
  number of events:
    v: 4
  number affected:
    v: 3
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-30-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_30_EG001
title:
  v: Dyspnea as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-30
    reference:
      v: #NCT03640312-OtherAdverseEvent-30
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.06666666666666667
  number of events:
    v: 2
  number affected:
    v: 2
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-30
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Dyspnea as other adverse event
status:
  v: active
note:
  text:
    v: 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)
definition:
  concept:
    text:
      v: Dyspnea as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Respiratory, thoracic and mediastinal disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-31-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_31_EG000
title:
  v: Respiration Abnormal as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-31
    reference:
      v: #NCT03640312-OtherAdverseEvent-31
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03125
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-31-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_31_EG001
title:
  v: Respiration Abnormal as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-31
    reference:
      v: #NCT03640312-OtherAdverseEvent-31
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-31
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Respiration Abnormal as other adverse event
status:
  v: active
note:
  text:
    v: Breathing problem, severe, resolved without sequelae, unlikely relatedness, no IP action taken
definition:
  concept:
    text:
      v: Respiration Abnormal as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Respiratory, thoracic and mediastinal disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-32-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_32_EG000
title:
  v: Hyperhidrosis as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-32
    reference:
      v: #NCT03640312-OtherAdverseEvent-32
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03125
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-32-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_32_EG001
title:
  v: Hyperhidrosis as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-32
    reference:
      v: #NCT03640312-OtherAdverseEvent-32
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03333333333333333
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-32
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Hyperhidrosis as other adverse event
status:
  v: active
note:
  text:
    v: 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)
definition:
  concept:
    text:
      v: Hyperhidrosis as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Skin and subcutaneous tissue disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-33-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_33_EG000
title:
  v: Rash as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-33
    reference:
      v: #NCT03640312-OtherAdverseEvent-33
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03125
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-33-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_33_EG001
title:
  v: Rash as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-33
    reference:
      v: #NCT03640312-OtherAdverseEvent-33
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0
  number of events:
    v: 0
  number affected:
    v: 0
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-33
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Rash as other adverse event
status:
  v: active
note:
  text:
    v: Rash, mild, resolved without sequelae, unlikely relatedness, no IP action taken
definition:
  concept:
    text:
      v: Rash as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Skin and subcutaneous tissue disorders
timing:
  text:
    v: 12 weeks

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-34-EG000
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_34_EG000
title:
  v: Dizziness as other adverse event for QUARTET LDQT in NCT03640312
status:
  v: active
variable definition:
  description:
    v: QUARTET LDQT
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-34
    reference:
      v: #NCT03640312-OtherAdverseEvent-34
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.125
  number of events:
    v: 4
  number affected:
    v: 4
  sample size:
    known data count:
      v: 32

Evidence
id:
  v: NCT03640312-OtherAdverseEvent-34-EG001
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/non-comparative-evidence
    l: non-comparative-evidence
name:
  v: NCT03640312_OtherAdverseEvent_34_EG001
title:
  v: Dizziness as other adverse event for Candesartan in NCT03640312
status:
  v: active
variable definition:
  description:
    v: Candesartan
  variable role:
    v: population
  observed:
    display:
      v: 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.
variable definition:
  note:
    text:
      v: 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.
  variable role:
    v: outcome
  observed:
    l: NCT03640312-OtherAdverseEvent-34
    reference:
      v: #NCT03640312-OtherAdverseEvent-34
    type:
      v: EvidenceVariable
      l: EvidenceVariable
statistic:
  statistic type:
    text:
      v: Percentage
  quantity:
    value:
      v: 0.03333333333333333
  number of events:
    v: 1
  number affected:
    v: 1
  sample size:
    known data count:
      v: 30

EvidenceVariable
id:
  v: NCT03640312-OtherAdverseEvent-34
meta:
  profile:
    v: http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition
    l: variable-definition
title:
  v: Dizziness as other adverse event
status:
  v: active
note:
  text:
    v: 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)
definition:
  concept:
    text:
      v: Dizziness as other adverse event
definition modifier:
  code:
    text:
      v: Adverse event assessment type
  value: CodeableConcept
    coding:
      system:
        v: http://hl7.org/fhir/definition-method
        l: definition-method
      code:
        v: systematic-assessment
      display:
        v: Systematic Assessment
definition modifier:
  code:
    text:
      v: Source Vocabulary for Adverse Event Definition
  value: CodeableConcept
    text:
      v: MedDRA 23.0
handling:
  v: boolean
classifier:
  text:
    v: Other Adverse Event
classifier:
  text:
    v: Vascular disorders
timing:
  text:
    v: 12 weeks

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

type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/v2-0203
      l: v2-0203
    code:
      v: ACSN
    display:
      v: Accession ID
  text:
    v: FEvIR Object Identifier
system:
  v: https://fevir.net/FOI
  l: FOI
value:
  v: 370505
assigner:
  display:
    v: Computable Publishing LLC

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

v: final

coding:
  system:
    v: https://fevir.net/resources/CodeSystem/179423
    l: https://fevir.net/resources/CodeSystem/179423
  code:
    v: OutcomeMeasureReport
  display:
    v: OutcomeMeasureReport
text:
  v: Outcome Measure Report

v: 2025-08-18T13:22:42.074Z

display:
  v: [No author listed.]

v: Adverse Events Report for NCT03640312

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

type:
  v: cite-as
target: Markdown
  v: 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/resources/Composition/370505.

title:
  v: Events Frequency Threshold
code:
  text:
    v: EventsFrequencyThreshold
text:
  status:
    v: generated
  div:
    v: 0%

title:
  v: Events Time Frame
code:
  text:
    v: EventsTimeFrame
text:
  status:
    v: generated
  div:
    v: 12 weeks

title:
  v: Events Description
code:
  text:
    v: EventsDescription
text:
  status:
    v: generated
  div:
    v: 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.

title:
  v: QUARTET LDQT
code:
  text:
    v: EG000 QUARTET LDQT
section:
  title:
    v: Event Group Description
  code:
    text:
      v: EventGroupDescription
  text:
    status:
      v: generated
    div:
      v: 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.

title:
  v: Candesartan
code:
  text:
    v: EG001 Candesartan
section:
  title:
    v: Event Group Description
  code:
    text:
      v: EventGroupDescription
  text:
    status:
      v: generated
    div:
      v: 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.

title:
  v: Total Mortality
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
  text:
    v: Total Mortality
focus:
  l: NCT03640312-AllCauseMortality
  reference:
    v: #NCT03640312-AllCauseMortality
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: All-cause mortality (timeframe for NCT03640312)
entry:
  l: NCT03640312-AllCauseMortality-EG000
  reference:
    v: #NCT03640312-AllCauseMortality-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: All-cause mortality for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-AllCauseMortality-EG001
  reference:
    v: #NCT03640312-AllCauseMortality-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: All-cause mortality for Candesartan in NCT03640312

title:
  v: Total Serious Events
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
  text:
    v: Total Serious Events
focus:
  l: NCT03640312-SeriousAdverseEvents
  reference:
    v: #NCT03640312-SeriousAdverseEvents
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Serious Adverse Events (timeframe for NCT03640312)
entry:
  l: NCT03640312-SeriousAdverseEvents-EG000
  reference:
    v: #NCT03640312-SeriousAdverseEvents-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Serious Adverse Events for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-SeriousAdverseEvents-EG001
  reference:
    v: #NCT03640312-SeriousAdverseEvents-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Serious Adverse Events for Candesartan in NCT03640312

title:
  v: Total Other Events
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
  text:
    v: Total Other Events
focus:
  l: NCT03640312-OtherAdverseEvents
  reference:
    v: #NCT03640312-OtherAdverseEvents
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Other Adverse Events (timeframe for NCT03640312)
entry:
  l: NCT03640312-OtherAdverseEvents-EG000
  reference:
    v: #NCT03640312-OtherAdverseEvents-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Other Adverse Events for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-OtherAdverseEvents-EG001
  reference:
    v: #NCT03640312-OtherAdverseEvents-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Other Adverse Events for Candesartan in NCT03640312

title:
  v: Serious Event List
code:
  text:
    v: SeriousEventList
section:
  title:
    v: Road Traffic Accident
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: results
      display:
        v: Results
  focus:
    l: NCT03640312-SeriousAdverseEvent-0
    reference:
      v: #NCT03640312-SeriousAdverseEvent-0
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    display:
      v: Road Traffic Accident as serious adverse event
  entry:
    l: NCT03640312-SeriousAdverseEvent-0-EG000
    reference:
      v: #NCT03640312-SeriousAdverseEvent-0-EG000
    type:
      v: Evidence
      l: Evidence
    display:
      v: Road Traffic Accident as serious adverse event for QUARTET LDQT in NCT03640312
  entry:
    l: NCT03640312-SeriousAdverseEvent-0-EG001
    reference:
      v: #NCT03640312-SeriousAdverseEvent-0-EG001
    type:
      v: Evidence
      l: Evidence
    display:
      v: Road Traffic Accident as serious adverse event for Candesartan in NCT03640312
section:
  title:
    v: Chest Pain
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: results
      display:
        v: Results
  focus:
    l: NCT03640312-SeriousAdverseEvent-1
    reference:
      v: #NCT03640312-SeriousAdverseEvent-1
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    display:
      v: Chest Pain as serious adverse event
  entry:
    l: NCT03640312-SeriousAdverseEvent-1-EG000
    reference:
      v: #NCT03640312-SeriousAdverseEvent-1-EG000
    type:
      v: Evidence
      l: Evidence
    display:
      v: Chest Pain as serious adverse event for QUARTET LDQT in NCT03640312
  entry:
    l: NCT03640312-SeriousAdverseEvent-1-EG001
    reference:
      v: #NCT03640312-SeriousAdverseEvent-1-EG001
    type:
      v: Evidence
      l: Evidence
    display:
      v: Chest Pain as serious adverse event for Candesartan in NCT03640312

title:
  v: Other Event List
code:
  text:
    v: OtherEventList
section:
  title:
    v: Vision blurred
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: results
      display:
        v: Results
  focus:
    l: NCT03640312-OtherAdverseEvent-0
    reference:
      v: #NCT03640312-OtherAdverseEvent-0
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    display:
      v: Vision blurred as other adverse event
  entry:
    l: NCT03640312-OtherAdverseEvent-0-EG000
    reference:
      v: #NCT03640312-OtherAdverseEvent-0-EG000
    type:
      v: Evidence
      l: Evidence
    display:
      v: Vision blurred as other adverse event for QUARTET LDQT in NCT03640312
  entry:
    l: NCT03640312-OtherAdverseEvent-0-EG001
    reference:
      v: #NCT03640312-OtherAdverseEvent-0-EG001
    type:
      v: Evidence
      l: Evidence
    display:
      v: Vision blurred as other adverse event for Candesartan in NCT03640312
section:
  title:
    v: Palpitations
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: results
      display:
        v: Results
  focus:
    l: NCT03640312-OtherAdverseEvent-1
    reference:
      v: #NCT03640312-OtherAdverseEvent-1
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    display:
      v: Palpitations as other adverse event
  entry:
    l: NCT03640312-OtherAdverseEvent-1-EG000
    reference:
      v: #NCT03640312-OtherAdverseEvent-1-EG000
    type:
      v: Evidence
      l: Evidence
    display:
      v: Palpitations as other adverse event for QUARTET LDQT in NCT03640312
  entry:
    l: NCT03640312-OtherAdverseEvent-1-EG001
    reference:
      v: #NCT03640312-OtherAdverseEvent-1-EG001
    type:
      v: Evidence
      l: Evidence
    display:
      v: Palpitations as other adverse event for Candesartan in NCT03640312
section:
  title:
    v: Tinnitus
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: results
      display:
        v: Results
  focus:
    l: NCT03640312-OtherAdverseEvent-2
    reference:
      v: #NCT03640312-OtherAdverseEvent-2
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    display:
      v: Tinnitus as other adverse event
  entry:
    l: NCT03640312-OtherAdverseEvent-2-EG000
    reference:
      v: #NCT03640312-OtherAdverseEvent-2-EG000
    type:
      v: Evidence
      l: Evidence
    display:
      v: Tinnitus as other adverse event for QUARTET LDQT in NCT03640312
  entry:
    l: NCT03640312-OtherAdverseEvent-2-EG001
    reference:
      v: #NCT03640312-OtherAdverseEvent-2-EG001
    type:
      v: Evidence
      l: Evidence
    display:
      v: Tinnitus as other adverse event for Candesartan in NCT03640312
section:
  title:
    v: Eye pruritis
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: results
      display:
        v: Results
  focus:
    l: NCT03640312-OtherAdverseEvent-3
    reference:
      v: #NCT03640312-OtherAdverseEvent-3
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    display:
      v: Eye pruritis as other adverse event
  entry:
    l: NCT03640312-OtherAdverseEvent-3-EG000
    reference:
      v: #NCT03640312-OtherAdverseEvent-3-EG000
    type:
      v: Evidence
      l: Evidence
    display:
      v: Eye pruritis as other adverse event for QUARTET LDQT in NCT03640312
  entry:
    l: NCT03640312-OtherAdverseEvent-3-EG001
    reference:
      v: #NCT03640312-OtherAdverseEvent-3-EG001
    type:
      v: Evidence
      l: Evidence
    display:
      v: Eye pruritis as other adverse event for Candesartan in NCT03640312
section:
  title:
    v: Diarrhea
  code:
    coding:
      system:
        v: https://fevir.net/resources/CodeSystem/179423
        l: https://fevir.net/resources/CodeSystem/179423
      code:
        v: results
      display:
        v: Results
  focus:
    l: NCT03640312-OtherAdverseEvent-4
    reference:
      v: #NCT03640312-OtherAdverseEvent-4
    type:
      v: EvidenceVariable
      l: EvidenceVariable
    display:
      v: Diarrhea as other adverse event
  entry:
    l: NCT03640312-OtherAdverseEvent-4-EG000
    reference:
      v: #NCT03640312-OtherAdverseEvent-4-EG000
    type:
      v: Evidence
      l: Evidence
    display:
      v: Diarrhea as other adverse event for QUARTET LDQT in NCT03640312
  entry:
    l: NCT03640312-OtherAdverseEvent-4-EG001
    reference:
      v: #NCT03640312-OtherAdverseEvent-4-EG001
    type:
      v: Evidence
      l: Evidence
    display:
      v: Diarrhea as other adverse event for Candesartan in NCT03640312

title:
  v: Abdominal pain upper
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03640312-OtherAdverseEvent-5
  reference:
    v: #NCT03640312-OtherAdverseEvent-5
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Abdominal pain upper as other adverse event
entry:
  l: NCT03640312-OtherAdverseEvent-5-EG000
  reference:
    v: #NCT03640312-OtherAdverseEvent-5-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Abdominal pain upper as other adverse event for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-OtherAdverseEvent-5-EG001
  reference:
    v: #NCT03640312-OtherAdverseEvent-5-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Abdominal pain upper as other adverse event for Candesartan in NCT03640312

title:
  v: Dry Mouth
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03640312-OtherAdverseEvent-6
  reference:
    v: #NCT03640312-OtherAdverseEvent-6
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Dry Mouth as other adverse event
entry:
  l: NCT03640312-OtherAdverseEvent-6-EG000
  reference:
    v: #NCT03640312-OtherAdverseEvent-6-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Dry Mouth as other adverse event for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-OtherAdverseEvent-6-EG001
  reference:
    v: #NCT03640312-OtherAdverseEvent-6-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Dry Mouth as other adverse event for Candesartan in NCT03640312

title:
  v: Constipation
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03640312-OtherAdverseEvent-7
  reference:
    v: #NCT03640312-OtherAdverseEvent-7
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Constipation as other adverse event
entry:
  l: NCT03640312-OtherAdverseEvent-7-EG000
  reference:
    v: #NCT03640312-OtherAdverseEvent-7-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Constipation as other adverse event for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-OtherAdverseEvent-7-EG001
  reference:
    v: #NCT03640312-OtherAdverseEvent-7-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Constipation as other adverse event for Candesartan in NCT03640312

title:
  v: Throat irritation
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03640312-OtherAdverseEvent-8
  reference:
    v: #NCT03640312-OtherAdverseEvent-8
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Throat irritation as other adverse event
entry:
  l: NCT03640312-OtherAdverseEvent-8-EG000
  reference:
    v: #NCT03640312-OtherAdverseEvent-8-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Throat irritation as other adverse event for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-OtherAdverseEvent-8-EG001
  reference:
    v: #NCT03640312-OtherAdverseEvent-8-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Throat irritation as other adverse event for Candesartan in NCT03640312

title:
  v: Nausea
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03640312-OtherAdverseEvent-9
  reference:
    v: #NCT03640312-OtherAdverseEvent-9
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Nausea as other adverse event
entry:
  l: NCT03640312-OtherAdverseEvent-9-EG000
  reference:
    v: #NCT03640312-OtherAdverseEvent-9-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Nausea as other adverse event for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-OtherAdverseEvent-9-EG001
  reference:
    v: #NCT03640312-OtherAdverseEvent-9-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Nausea as other adverse event for Candesartan in NCT03640312

title:
  v: Dry throat
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03640312-OtherAdverseEvent-10
  reference:
    v: #NCT03640312-OtherAdverseEvent-10
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Dry throat as other adverse event
entry:
  l: NCT03640312-OtherAdverseEvent-10-EG000
  reference:
    v: #NCT03640312-OtherAdverseEvent-10-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Dry throat as other adverse event for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-OtherAdverseEvent-10-EG001
  reference:
    v: #NCT03640312-OtherAdverseEvent-10-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Dry throat as other adverse event for Candesartan in NCT03640312

title:
  v: Vomiting
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03640312-OtherAdverseEvent-11
  reference:
    v: #NCT03640312-OtherAdverseEvent-11
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Vomiting as other adverse event
entry:
  l: NCT03640312-OtherAdverseEvent-11-EG000
  reference:
    v: #NCT03640312-OtherAdverseEvent-11-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Vomiting as other adverse event for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-OtherAdverseEvent-11-EG001
  reference:
    v: #NCT03640312-OtherAdverseEvent-11-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Vomiting as other adverse event for Candesartan in NCT03640312

title:
  v: Feeling Hot
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03640312-OtherAdverseEvent-12
  reference:
    v: #NCT03640312-OtherAdverseEvent-12
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Feeling Hot as other adverse event
entry:
  l: NCT03640312-OtherAdverseEvent-12-EG000
  reference:
    v: #NCT03640312-OtherAdverseEvent-12-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Feeling Hot as other adverse event for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-OtherAdverseEvent-12-EG001
  reference:
    v: #NCT03640312-OtherAdverseEvent-12-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Feeling Hot as other adverse event for Candesartan in NCT03640312

title:
  v: Influenza like illness
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03640312-OtherAdverseEvent-13
  reference:
    v: #NCT03640312-OtherAdverseEvent-13
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Influenza like illness as other adverse event
entry:
  l: NCT03640312-OtherAdverseEvent-13-EG000
  reference:
    v: #NCT03640312-OtherAdverseEvent-13-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Influenza like illness as other adverse event for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-OtherAdverseEvent-13-EG001
  reference:
    v: #NCT03640312-OtherAdverseEvent-13-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Influenza like illness as other adverse event for Candesartan in NCT03640312

title:
  v: Fatigue
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03640312-OtherAdverseEvent-14
  reference:
    v: #NCT03640312-OtherAdverseEvent-14
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Fatigue as other adverse event
entry:
  l: NCT03640312-OtherAdverseEvent-14-EG000
  reference:
    v: #NCT03640312-OtherAdverseEvent-14-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Fatigue as other adverse event for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-OtherAdverseEvent-14-EG001
  reference:
    v: #NCT03640312-OtherAdverseEvent-14-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Fatigue as other adverse event for Candesartan in NCT03640312

title:
  v: Peripheral swelling
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03640312-OtherAdverseEvent-15
  reference:
    v: #NCT03640312-OtherAdverseEvent-15
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Peripheral swelling as other adverse event
entry:
  l: NCT03640312-OtherAdverseEvent-15-EG000
  reference:
    v: #NCT03640312-OtherAdverseEvent-15-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Peripheral swelling as other adverse event for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-OtherAdverseEvent-15-EG001
  reference:
    v: #NCT03640312-OtherAdverseEvent-15-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Peripheral swelling as other adverse event for Candesartan in NCT03640312

title:
  v: Chest Pain
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03640312-OtherAdverseEvent-16
  reference:
    v: #NCT03640312-OtherAdverseEvent-16
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Chest Pain as other adverse event
entry:
  l: NCT03640312-OtherAdverseEvent-16-EG000
  reference:
    v: #NCT03640312-OtherAdverseEvent-16-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Chest Pain as other adverse event for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-OtherAdverseEvent-16-EG001
  reference:
    v: #NCT03640312-OtherAdverseEvent-16-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Chest Pain as other adverse event for Candesartan in NCT03640312

title:
  v: Asthenia
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03640312-OtherAdverseEvent-17
  reference:
    v: #NCT03640312-OtherAdverseEvent-17
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Asthenia as other adverse event
entry:
  l: NCT03640312-OtherAdverseEvent-17-EG000
  reference:
    v: #NCT03640312-OtherAdverseEvent-17-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Asthenia as other adverse event for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-OtherAdverseEvent-17-EG001
  reference:
    v: #NCT03640312-OtherAdverseEvent-17-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Asthenia as other adverse event for Candesartan in NCT03640312

title:
  v: Pain
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03640312-OtherAdverseEvent-18
  reference:
    v: #NCT03640312-OtherAdverseEvent-18
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Pain as other adverse event
entry:
  l: NCT03640312-OtherAdverseEvent-18-EG000
  reference:
    v: #NCT03640312-OtherAdverseEvent-18-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Pain as other adverse event for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-OtherAdverseEvent-18-EG001
  reference:
    v: #NCT03640312-OtherAdverseEvent-18-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Pain as other adverse event for Candesartan in NCT03640312

title:
  v: Blood glucose increased
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03640312-OtherAdverseEvent-19
  reference:
    v: #NCT03640312-OtherAdverseEvent-19
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Blood glucose increased as other adverse event
entry:
  l: NCT03640312-OtherAdverseEvent-19-EG000
  reference:
    v: #NCT03640312-OtherAdverseEvent-19-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Blood glucose increased as other adverse event for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-OtherAdverseEvent-19-EG001
  reference:
    v: #NCT03640312-OtherAdverseEvent-19-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Blood glucose increased as other adverse event for Candesartan in NCT03640312

title:
  v: Heart rate irregular
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03640312-OtherAdverseEvent-20
  reference:
    v: #NCT03640312-OtherAdverseEvent-20
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Heart rate irregular as other adverse event
entry:
  l: NCT03640312-OtherAdverseEvent-20-EG000
  reference:
    v: #NCT03640312-OtherAdverseEvent-20-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Heart rate irregular as other adverse event for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-OtherAdverseEvent-20-EG001
  reference:
    v: #NCT03640312-OtherAdverseEvent-20-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Heart rate irregular as other adverse event for Candesartan in NCT03640312

title:
  v: Back pain
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03640312-OtherAdverseEvent-21
  reference:
    v: #NCT03640312-OtherAdverseEvent-21
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Back pain as other adverse event
entry:
  l: NCT03640312-OtherAdverseEvent-21-EG000
  reference:
    v: #NCT03640312-OtherAdverseEvent-21-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Back pain as other adverse event for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-OtherAdverseEvent-21-EG001
  reference:
    v: #NCT03640312-OtherAdverseEvent-21-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Back pain as other adverse event for Candesartan in NCT03640312

title:
  v: Muscle cramps/spasms
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03640312-OtherAdverseEvent-22
  reference:
    v: #NCT03640312-OtherAdverseEvent-22
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Muscle cramps/spasms as other adverse event
entry:
  l: NCT03640312-OtherAdverseEvent-22-EG000
  reference:
    v: #NCT03640312-OtherAdverseEvent-22-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Muscle cramps/spasms as other adverse event for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-OtherAdverseEvent-22-EG001
  reference:
    v: #NCT03640312-OtherAdverseEvent-22-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Muscle cramps/spasms as other adverse event for Candesartan in NCT03640312

title:
  v: Headache
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03640312-OtherAdverseEvent-23
  reference:
    v: #NCT03640312-OtherAdverseEvent-23
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Headache as other adverse event
entry:
  l: NCT03640312-OtherAdverseEvent-23-EG000
  reference:
    v: #NCT03640312-OtherAdverseEvent-23-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Headache as other adverse event for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-OtherAdverseEvent-23-EG001
  reference:
    v: #NCT03640312-OtherAdverseEvent-23-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Headache as other adverse event for Candesartan in NCT03640312

title:
  v: Dizziness
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03640312-OtherAdverseEvent-24
  reference:
    v: #NCT03640312-OtherAdverseEvent-24
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Dizziness as other adverse event
entry:
  l: NCT03640312-OtherAdverseEvent-24-EG000
  reference:
    v: #NCT03640312-OtherAdverseEvent-24-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Dizziness as other adverse event for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-OtherAdverseEvent-24-EG001
  reference:
    v: #NCT03640312-OtherAdverseEvent-24-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Dizziness as other adverse event for Candesartan in NCT03640312

title:
  v: Vision blurred
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03640312-OtherAdverseEvent-25
  reference:
    v: #NCT03640312-OtherAdverseEvent-25
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Vision blurred as other adverse event
entry:
  l: NCT03640312-OtherAdverseEvent-25-EG000
  reference:
    v: #NCT03640312-OtherAdverseEvent-25-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Vision blurred as other adverse event for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-OtherAdverseEvent-25-EG001
  reference:
    v: #NCT03640312-OtherAdverseEvent-25-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Vision blurred as other adverse event for Candesartan in NCT03640312

title:
  v: Hypoaesthesia
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03640312-OtherAdverseEvent-26
  reference:
    v: #NCT03640312-OtherAdverseEvent-26
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Hypoaesthesia as other adverse event
entry:
  l: NCT03640312-OtherAdverseEvent-26-EG000
  reference:
    v: #NCT03640312-OtherAdverseEvent-26-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Hypoaesthesia as other adverse event for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-OtherAdverseEvent-26-EG001
  reference:
    v: #NCT03640312-OtherAdverseEvent-26-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Hypoaesthesia as other adverse event for Candesartan in NCT03640312

title:
  v: Anxiety
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03640312-OtherAdverseEvent-27
  reference:
    v: #NCT03640312-OtherAdverseEvent-27
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Anxiety as other adverse event
entry:
  l: NCT03640312-OtherAdverseEvent-27-EG000
  reference:
    v: #NCT03640312-OtherAdverseEvent-27-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Anxiety as other adverse event for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-OtherAdverseEvent-27-EG001
  reference:
    v: #NCT03640312-OtherAdverseEvent-27-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Anxiety as other adverse event for Candesartan in NCT03640312

title:
  v: Nasopharyngitis
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03640312-OtherAdverseEvent-28
  reference:
    v: #NCT03640312-OtherAdverseEvent-28
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Nasopharyngitis as other adverse event
entry:
  l: NCT03640312-OtherAdverseEvent-28-EG000
  reference:
    v: #NCT03640312-OtherAdverseEvent-28-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Nasopharyngitis as other adverse event for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-OtherAdverseEvent-28-EG001
  reference:
    v: #NCT03640312-OtherAdverseEvent-28-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Nasopharyngitis as other adverse event for Candesartan in NCT03640312

title:
  v: Cough
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03640312-OtherAdverseEvent-29
  reference:
    v: #NCT03640312-OtherAdverseEvent-29
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Cough as other adverse event
entry:
  l: NCT03640312-OtherAdverseEvent-29-EG000
  reference:
    v: #NCT03640312-OtherAdverseEvent-29-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Cough as other adverse event for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-OtherAdverseEvent-29-EG001
  reference:
    v: #NCT03640312-OtherAdverseEvent-29-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Cough as other adverse event for Candesartan in NCT03640312

title:
  v: Dyspnea
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03640312-OtherAdverseEvent-30
  reference:
    v: #NCT03640312-OtherAdverseEvent-30
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Dyspnea as other adverse event
entry:
  l: NCT03640312-OtherAdverseEvent-30-EG000
  reference:
    v: #NCT03640312-OtherAdverseEvent-30-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Dyspnea as other adverse event for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-OtherAdverseEvent-30-EG001
  reference:
    v: #NCT03640312-OtherAdverseEvent-30-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Dyspnea as other adverse event for Candesartan in NCT03640312

title:
  v: Respiration Abnormal
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03640312-OtherAdverseEvent-31
  reference:
    v: #NCT03640312-OtherAdverseEvent-31
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Respiration Abnormal as other adverse event
entry:
  l: NCT03640312-OtherAdverseEvent-31-EG000
  reference:
    v: #NCT03640312-OtherAdverseEvent-31-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Respiration Abnormal as other adverse event for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-OtherAdverseEvent-31-EG001
  reference:
    v: #NCT03640312-OtherAdverseEvent-31-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Respiration Abnormal as other adverse event for Candesartan in NCT03640312

title:
  v: Hyperhidrosis
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03640312-OtherAdverseEvent-32
  reference:
    v: #NCT03640312-OtherAdverseEvent-32
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Hyperhidrosis as other adverse event
entry:
  l: NCT03640312-OtherAdverseEvent-32-EG000
  reference:
    v: #NCT03640312-OtherAdverseEvent-32-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Hyperhidrosis as other adverse event for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-OtherAdverseEvent-32-EG001
  reference:
    v: #NCT03640312-OtherAdverseEvent-32-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Hyperhidrosis as other adverse event for Candesartan in NCT03640312

title:
  v: Rash
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03640312-OtherAdverseEvent-33
  reference:
    v: #NCT03640312-OtherAdverseEvent-33
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Rash as other adverse event
entry:
  l: NCT03640312-OtherAdverseEvent-33-EG000
  reference:
    v: #NCT03640312-OtherAdverseEvent-33-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Rash as other adverse event for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-OtherAdverseEvent-33-EG001
  reference:
    v: #NCT03640312-OtherAdverseEvent-33-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Rash as other adverse event for Candesartan in NCT03640312

title:
  v: Dizziness
code:
  coding:
    system:
      v: https://fevir.net/resources/CodeSystem/179423
      l: https://fevir.net/resources/CodeSystem/179423
    code:
      v: results
    display:
      v: Results
focus:
  l: NCT03640312-OtherAdverseEvent-34
  reference:
    v: #NCT03640312-OtherAdverseEvent-34
  type:
    v: EvidenceVariable
    l: EvidenceVariable
  display:
    v: Dizziness as other adverse event
entry:
  l: NCT03640312-OtherAdverseEvent-34-EG000
  reference:
    v: #NCT03640312-OtherAdverseEvent-34-EG000
  type:
    v: Evidence
    l: Evidence
  display:
    v: Dizziness as other adverse event for QUARTET LDQT in NCT03640312
entry:
  l: NCT03640312-OtherAdverseEvent-34-EG001
  reference:
    v: #NCT03640312-OtherAdverseEvent-34-EG001
  type:
    v: Evidence
    l: Evidence
  display:
    v: Dizziness as other adverse event for Candesartan in NCT03640312