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: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable All-cause mortality (timeframe for NCT03640312) statistic statisticType: Percentage quantity: 0 numberAffected: 0 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-SeriousAdverseEvents-EG000 Profile: NonComparativeEvidence name: NCT03640312_SeriousAdverseEvents_EG000 title: Serious Adverse Events for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Serious Adverse Events (timeframe for NCT03640312) statistic statisticType: Percentage quantity: 0.0625 numberAffected: 2 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvents-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvents_EG000 title: Other Adverse Events for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Other Adverse Events (timeframe for NCT03640312) statistic statisticType: Percentage quantity: 0.625 numberAffected: 20 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-AllCauseMortality-EG001 Profile: NonComparativeEvidence name: NCT03640312_AllCauseMortality_EG001 title: All-cause mortality for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable All-cause mortality (timeframe for NCT03640312) statistic statisticType: Percentage quantity: 0 numberAffected: 0 SampleSizes - KnownDataCount * 30 Generated Narrative: Evidence #NCT03640312-SeriousAdverseEvents-EG001 Profile: NonComparativeEvidence name: NCT03640312_SeriousAdverseEvents_EG001 title: Serious Adverse Events for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Serious Adverse Events (timeframe for NCT03640312) statistic statisticType: Percentage quantity: 0 numberAffected: 0 SampleSizes - KnownDataCount * 30 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvents-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvents_EG001 title: Other Adverse Events for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Other Adverse Events (timeframe for NCT03640312) statistic statisticType: Percentage quantity: 0.4666666666666667 numberAffected: 14 SampleSizes - KnownDataCount * 30 Generated Narrative: Evidence #NCT03640312-SeriousAdverseEvent-0-EG000 Profile: NonComparativeEvidence name: NCT03640312_SeriousAdverseEvent_0_EG000 title: Road Traffic Accident as serious adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Road Traffic Accident as serious adverse event statistic statisticType: Percentage quantity: 0.03125 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-SeriousAdverseEvent-0-EG001 Profile: NonComparativeEvidence name: NCT03640312_SeriousAdverseEvent_0_EG001 title: Road Traffic Accident as serious adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Road Traffic Accident as serious adverse event statistic SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-SeriousAdverseEvent-0 Profile: VariableDefinition title: Road Traffic Accident as serious adverse event status: Active note: Motor Vehicle Accident. Severity: Severe. Outcome: Resolved with sequelae. Blinded relatedness assessment: Unrelated. Investigational product action taken: Temporarily Withdrawn. Resulted in hospitalization. Definitions - Concept * Road Traffic Accident as serious adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Serious Adverse Event, Injury, poisoning and procedural complications Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-SeriousAdverseEvent-1-EG000 Profile: NonComparativeEvidence name: NCT03640312_SeriousAdverseEvent_1_EG000 title: Chest Pain as serious adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Chest Pain as serious adverse event statistic statisticType: Percentage quantity: 0.03125 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-SeriousAdverseEvent-1-EG001 Profile: NonComparativeEvidence name: NCT03640312_SeriousAdverseEvent_1_EG001 title: Chest Pain as serious adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Chest Pain as serious adverse event statistic SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-SeriousAdverseEvent-1 Profile: VariableDefinition title: Chest Pain as serious adverse event status: Active note: Severity: Severe. Outcome: Resolved with Sequelae. Relatedness Assessment: Unrelated. Investigational Product action taken: Temporarily Withdrawn. Resulted in hospitalization. Definitions - Concept * Chest Pain as serious adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Serious Adverse Event, General disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-0-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_0_EG000 title: Vision blurred as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Vision blurred as other adverse event statistic statisticType: Percentage quantity: 0.03125 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-0-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_0_EG001 title: Vision blurred as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Vision blurred as other adverse event statistic statisticType: Percentage quantity: 0.03333333333333333 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-0 Profile: VariableDefinition title: Vision blurred as other adverse event status: Active note: 2 Total events: Severity: Mild. Outcome: Ongoing at study exit. Relatedness assessment: Unrelated. Investigational product action taken: None. Study arm: Candesartan Severe, resolved without sequelae, unlikely related, no action taken, LDQT Definitions - Concept * Vision blurred as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, Eye disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-1-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_1_EG000 title: Palpitations as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Palpitations as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-1-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_1_EG001 title: Palpitations as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Palpitations as other adverse event statistic statisticType: Percentage quantity: 0.03333333333333333 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-1 Profile: VariableDefinition title: Palpitations as other adverse event status: Active note: Palpitations, mild, resolved without sequelae, possible relatedness, no IP action taken. Definitions - Concept * Palpitations as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, Cardiac disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-2-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_2_EG000 title: Tinnitus as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Tinnitus as other adverse event statistic statisticType: Percentage quantity: 0.03125 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-2-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_2_EG001 title: Tinnitus as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Tinnitus as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-2 Profile: VariableDefinition title: Tinnitus as other adverse event status: Active note: Ringing in ears, mild, ongoing at study exit, assessed unrelated, no IP action taken. Definitions - Concept * Tinnitus as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, Ear and labyrinth disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-3-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_3_EG000 title: Eye pruritis as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Eye pruritis as other adverse event statistic statisticType: Percentage quantity: 0.03125 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-3-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_3_EG001 title: Eye pruritis as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Eye pruritis as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-3 Profile: VariableDefinition title: Eye pruritis as other adverse event status: Active note: Itchy eyes, mild, resolved without sequelae, unlikely relatedness, no IP action taken Definitions - Concept * Eye pruritis as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, Eye disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-4-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_4_EG000 title: Diarrhea as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Diarrhea as other adverse event statistic statisticType: Percentage quantity: 0.09375 numberOfEvents: 3 numberAffected: 3 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-4-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_4_EG001 title: Diarrhea as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Diarrhea as other adverse event statistic statisticType: Percentage quantity: 0.06666666666666667 numberOfEvents: 2 numberAffected: 2 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-4 Profile: VariableDefinition title: Diarrhea as other adverse event status: Active note: 5 total events (2 control, 3 LDQT) Diarrhea, mild (5/5), resolved w/o sequelae (4/5) ongoing at study exit (1/5), unlikely (2/5) unrelated (3/5), no IP action taken (4/5) temporarily withdrawn (1/5). Definitions - Concept * Diarrhea as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, Gastrointestinal disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-5-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_5_EG000 title: Abdominal pain upper as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Abdominal pain upper as other adverse event statistic statisticType: Percentage quantity: 0.03125 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-5-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_5_EG001 title: Abdominal pain upper as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Abdominal pain upper as other adverse event statistic statisticType: Percentage quantity: 0.06666666666666667 numberOfEvents: 2 numberAffected: 2 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-5 Profile: VariableDefinition title: Abdominal pain upper as other adverse event status: Active note: 3 total Stomach cramping (1/3) stomach gas/pain (2/3), mild (3/3), resolved without sequelae (2/3) ongoing at study exit (1/3), unrelated (3/3), no IP action taken (1/3) temporarily withdrawn (1/3) permanently discontinued (1/3) Definitions - Concept * Abdominal pain upper as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, Gastrointestinal disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-6-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_6_EG000 title: Dry Mouth as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Dry Mouth as other adverse event statistic statisticType: Percentage quantity: 0.03125 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-6-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_6_EG001 title: Dry Mouth as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Dry Mouth as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-6 Profile: VariableDefinition title: Dry Mouth as other adverse event status: Active note: mild, resolved without sequelae, unrelated, no IP action taken Definitions - Concept * Dry Mouth as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, Gastrointestinal disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-7-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_7_EG000 title: Constipation as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Constipation as other adverse event statistic statisticType: Percentage quantity: 0.03125 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-7-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_7_EG001 title: Constipation as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Constipation as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-7 Profile: VariableDefinition title: Constipation as other adverse event status: Active note: mild, resolved without sequelae, unrelated, no IP action taken Definitions - Concept * Constipation as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, Gastrointestinal disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-8-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_8_EG000 title: Throat irritation as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Throat irritation as other adverse event statistic statisticType: Percentage quantity: 0.03125 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-8-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_8_EG001 title: Throat irritation as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Throat irritation as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-8 Profile: VariableDefinition title: Throat irritation as other adverse event status: Active note: mild, resolved without sequelae, possible relatedness, no IP action taken Definitions - Concept * Throat irritation as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, Gastrointestinal disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-9-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_9_EG000 title: Nausea as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Nausea as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-9-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_9_EG001 title: Nausea as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Nausea as other adverse event statistic statisticType: Percentage quantity: 0.03333333333333333 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-9 Profile: VariableDefinition title: Nausea as other adverse event status: Active note: Nausea/vomiting, mild, resolved without sequelae, possible relatedness, permanently discontinued Definitions - Concept * Nausea as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, Gastrointestinal disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-10-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_10_EG000 title: Dry throat as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Dry throat as other adverse event statistic statisticType: Percentage quantity: 0.03125 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-10-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_10_EG001 title: Dry throat as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Dry throat as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-10 Profile: VariableDefinition title: Dry throat as other adverse event status: Active note: mild, resolved without sequelae, possible relatedness, temporarily withdrawn Definitions - Concept * Dry throat as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, Gastrointestinal disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-11-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_11_EG000 title: Vomiting as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Vomiting as other adverse event statistic statisticType: Percentage quantity: 0.03125 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-11-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_11_EG001 title: Vomiting as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Vomiting as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-11 Profile: VariableDefinition title: Vomiting as other adverse event status: Active note: Nausea/Vomiting, mild, resolved without sequelae, unrelated, temporarily withdrawn Definitions - Concept * Vomiting as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, Gastrointestinal disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-12-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_12_EG000 title: Feeling Hot as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Feeling Hot as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-12-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_12_EG001 title: Feeling Hot as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Feeling Hot as other adverse event statistic statisticType: Percentage quantity: 0.03333333333333333 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-12 Profile: VariableDefinition title: Feeling Hot as other adverse event status: Active note: Feeling warm, moderate, resolved without sequelae, possible relatedness, permanently discontinued Definitions - Concept * Feeling Hot as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, General disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-13-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_13_EG000 title: Influenza like illness as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Influenza like illness as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-13-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_13_EG001 title: Influenza like illness as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Influenza like illness as other adverse event statistic statisticType: Percentage quantity: 0.03333333333333333 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-13 Profile: VariableDefinition title: Influenza like illness as other adverse event status: Active note: Flu-like symptoms, moderate, ongoing at study exit, unrelated, no IP action taken Definitions - Concept * Influenza like illness as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, General disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-14-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_14_EG000 title: Fatigue as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Fatigue as other adverse event statistic statisticType: Percentage quantity: 0.0625 numberOfEvents: 3 numberAffected: 2 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-14-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_14_EG001 title: Fatigue as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Fatigue as other adverse event statistic statisticType: Percentage quantity: 0.03333333333333333 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-14 Profile: VariableDefinition title: Fatigue as other adverse event status: Active note: 4 total mild (4/4), resolved without sequelae (4/4), unrelated (1/4) unlikely (2/4), possible (1/4), no IP action taken (4/4) Definitions - Concept * Fatigue as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, General disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-15-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_15_EG000 title: Peripheral swelling as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Peripheral swelling as other adverse event statistic statisticType: Percentage quantity: 0.03125 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-15-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_15_EG001 title: Peripheral swelling as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Peripheral swelling as other adverse event statistic statisticType: Percentage quantity: 0.1 numberOfEvents: 3 numberAffected: 3 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-15 Profile: VariableDefinition title: Peripheral swelling as other adverse event status: Active note: 4 total Swelling of legs/ankles (2/4) swelling of hands/feet (2/4), mild (4/4), resolved without sequelae (3/4) ongoing at study exit (1/4), unrelated (2/4) possible (2/4), no IP action taken (3/4) permanently discontinued (1/4) Definitions - Concept * Peripheral swelling as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, General disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-16-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_16_EG000 title: Chest Pain as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Chest Pain as other adverse event statistic statisticType: Percentage quantity: 0.03125 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-16-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_16_EG001 title: Chest Pain as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Chest Pain as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-16 Profile: VariableDefinition title: Chest Pain as other adverse event status: Active note: mild, resolved without sequelae, unrelated, no IP action taken Definitions - Concept * Chest Pain as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, General disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-17-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_17_EG000 title: Asthenia as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Asthenia as other adverse event statistic statisticType: Percentage quantity: 0.03125 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-17-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_17_EG001 title: Asthenia as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Asthenia as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-17 Profile: VariableDefinition title: Asthenia as other adverse event status: Active note: mild, resolved without sequelae, possible relatedness, temporarily withdrawn Definitions - Concept * Asthenia as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, General disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-18-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_18_EG000 title: Pain as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Pain as other adverse event statistic statisticType: Percentage quantity: 0.03125 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-18-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_18_EG001 title: Pain as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Pain as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-18 Profile: VariableDefinition title: Pain as other adverse event status: Active note: Body aches, mild, resolved without sequelae, unrelated, temporarily withdrawn Definitions - Concept * Pain as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, General disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-19-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_19_EG000 title: Blood glucose increased as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Blood glucose increased as other adverse event statistic statisticType: Percentage quantity: 0.03125 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-19-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_19_EG001 title: Blood glucose increased as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Blood glucose increased as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-19 Profile: VariableDefinition title: Blood glucose increased as other adverse event status: Active note: Elevated blood sugar, mild, ongoing at study exit, unlikely relatedness, no IP action taken Definitions - Concept * Blood glucose increased as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, Investigations Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-20-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_20_EG000 title: Heart rate irregular as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Heart rate irregular as other adverse event statistic statisticType: Percentage quantity: 0.0625 numberOfEvents: 2 numberAffected: 2 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-20-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_20_EG001 title: Heart rate irregular as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Heart rate irregular as other adverse event statistic statisticType: Percentage quantity: 0.06666666666666667 numberOfEvents: 3 numberAffected: 2 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-20 Profile: VariableDefinition title: Heart rate irregular as other adverse event status: Active note: 5 total irregular/fast heartbeat (5/5), mild (5/5), resolved without sequelae (4/5) ongoing at study exit (1/5), unrelated (2/5) unlikely (2/5) possible (1/5), no IP action taken (3/5) permanently discontinued (2/5) Definitions - Concept * Heart rate irregular as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, Investigations Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-21-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_21_EG000 title: Back pain as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Back pain as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-21-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_21_EG001 title: Back pain as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Back pain as other adverse event statistic statisticType: Percentage quantity: 0.03333333333333333 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-21 Profile: VariableDefinition title: Back pain as other adverse event status: Active note: mild, ongoing at study exit, unlikely relatedness, no IP action taken Definitions - Concept * Back pain as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, Musculoskeletal and connective tissue disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-22-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_22_EG000 title: Muscle cramps/spasms as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Muscle cramps/spasms as other adverse event statistic statisticType: Percentage quantity: 0.03125 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-22-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_22_EG001 title: Muscle cramps/spasms as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Muscle cramps/spasms as other adverse event statistic statisticType: Percentage quantity: 0.03333333333333333 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-22 Profile: VariableDefinition title: Muscle cramps/spasms as other adverse event status: Active note: 2 total mild (1/2) severe (1/2), resolved without sequelae (2/2), unrelated (1/2) unlikely (1/2), no IP action taken (2/2) Definitions - Concept * Muscle cramps/spasms as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, Musculoskeletal and connective tissue disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-23-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_23_EG000 title: Headache as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Headache as other adverse event statistic statisticType: Percentage quantity: 0.15625 numberOfEvents: 6 numberAffected: 5 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-23-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_23_EG001 title: Headache as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Headache as other adverse event statistic statisticType: Percentage quantity: 0.06666666666666667 numberOfEvents: 2 numberAffected: 2 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-23 Profile: VariableDefinition title: Headache as other adverse event status: Active note: 8 total mild (8/8), resolved without sequelae (7/8) ongoing at study exit (1/8), unrelated (4/8) unlikely (3/8) possible (1/8), no IP action taken (6/8) permanently discontinued (2/8) Definitions - Concept * Headache as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, Nervous system disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-24-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_24_EG000 title: Dizziness as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Dizziness as other adverse event statistic statisticType: Percentage quantity: 0.0625 numberOfEvents: 2 numberAffected: 2 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-24-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_24_EG001 title: Dizziness as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Dizziness as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-24 Profile: VariableDefinition title: Dizziness as other adverse event status: Active note: 2 total mild (2/2), resolved without sequelae (2/2), possible relatedness (2/2), no IP action taken (2/2) Definitions - Concept * Dizziness as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, Nervous system disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-25-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_25_EG000 title: Vision blurred as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Vision blurred as other adverse event statistic statisticType: Percentage quantity: 0.03125 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-25-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_25_EG001 title: Vision blurred as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Vision blurred as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-25 Profile: VariableDefinition title: Vision blurred as other adverse event status: Active note: Blurred vision/vision or hearing changes, mild, resolved without sequelae, unlikely relatedness, permanently discontinued Definitions - Concept * Vision blurred as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, Nervous system disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-26-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_26_EG000 title: Hypoaesthesia as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Hypoaesthesia as other adverse event statistic statisticType: Percentage quantity: 0.03125 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-26-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_26_EG001 title: Hypoaesthesia as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Hypoaesthesia as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-26 Profile: VariableDefinition title: Hypoaesthesia as other adverse event status: Active note: cold/tingling/numb hands/feet, mild, resolved without sequelae, unrelated, no IP action taken Definitions - Concept * Hypoaesthesia as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, Nervous system disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-27-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_27_EG000 title: Anxiety as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Anxiety as other adverse event statistic statisticType: Percentage quantity: 0.0625 numberOfEvents: 2 numberAffected: 2 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-27-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_27_EG001 title: Anxiety as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Anxiety as other adverse event statistic statisticType: Percentage quantity: 0.03333333333333333 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-27 Profile: VariableDefinition title: Anxiety as other adverse event status: Active note: 3 total mild (3/3), resolved without sequelae (1/3) resolved with sequelae (1/3) ongoing at study exit (1/3), unrelated (2/3) possible (1/3), no IP action taken (3/3) Definitions - Concept * Anxiety as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, Psychiatric disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-28-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_28_EG000 title: Nasopharyngitis as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Nasopharyngitis as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-28-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_28_EG001 title: Nasopharyngitis as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Nasopharyngitis as other adverse event statistic statisticType: Percentage quantity: 0.03333333333333333 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-28 Profile: VariableDefinition title: Nasopharyngitis as other adverse event status: Active note: Cold symptoms, mild, ongoing at study exit, unrelated, no IP action taken Definitions - Concept * Nasopharyngitis as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, Respiratory, thoracic and mediastinal disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-29-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_29_EG000 title: Cough as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Cough as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-29-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_29_EG001 title: Cough as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Cough as other adverse event statistic statisticType: Percentage quantity: 0.1 numberOfEvents: 3 numberAffected: 3 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-29 Profile: VariableDefinition title: Cough as other adverse event status: Active note: 3 total mild (3/3), resolved without sequelae (1/3) resolved with sequelae (1/3) ongoing at study exit (1/3), unrelated (2/3) unlikely (1/3), no IP action taken (3/3) Definitions - Concept * Cough as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, Respiratory, thoracic and mediastinal disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-30-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_30_EG000 title: Dyspnea as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Dyspnea as other adverse event statistic statisticType: Percentage quantity: 0.09375 numberOfEvents: 4 numberAffected: 3 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-30-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_30_EG001 title: Dyspnea as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Dyspnea as other adverse event statistic statisticType: Percentage quantity: 0.06666666666666667 numberOfEvents: 2 numberAffected: 2 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-30 Profile: VariableDefinition title: Dyspnea as other adverse event status: Active note: 6 total Breathing problems (6/6), mild (5/6) moderate (1/6), resolved without sequelae (3/6) resolved with sequelae (2/6) ongoing at study exit (1/6), unrelated (4/6) unlikely (2/6), no IP action taken (5/6) temporarily withdrawn (1/6) Definitions - Concept * Dyspnea as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, Respiratory, thoracic and mediastinal disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-31-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_31_EG000 title: Respiration Abnormal as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Respiration Abnormal as other adverse event statistic statisticType: Percentage quantity: 0.03125 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-31-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_31_EG001 title: Respiration Abnormal as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Respiration Abnormal as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-31 Profile: VariableDefinition title: Respiration Abnormal as other adverse event status: Active note: Breathing problem, severe, resolved without sequelae, unlikely relatedness, no IP action taken Definitions - Concept * Respiration Abnormal as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, Respiratory, thoracic and mediastinal disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-32-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_32_EG000 title: Hyperhidrosis as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Hyperhidrosis as other adverse event statistic statisticType: Percentage quantity: 0.03125 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-32-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_32_EG001 title: Hyperhidrosis as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Hyperhidrosis as other adverse event statistic statisticType: Percentage quantity: 0.03333333333333333 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-32 Profile: VariableDefinition title: Hyperhidrosis as other adverse event status: Active note: 2 total Sweating (2/2), mild (2/2), resolved without sequelae (2/2), unrealted (2/2), no IP action taken (1/2) permanently discontinued (1/2) Definitions - Concept * Hyperhidrosis as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, Skin and subcutaneous tissue disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-33-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_33_EG000 title: Rash as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Rash as other adverse event statistic statisticType: Percentage quantity: 0.03125 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-33-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_33_EG001 title: Rash as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Rash as other adverse event statistic statisticType: Percentage quantity: 0 numberOfEvents: 0 numberAffected: 0 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-33 Profile: VariableDefinition title: Rash as other adverse event status: Active note: Rash, mild, resolved without sequelae, unlikely relatedness, no IP action taken Definitions - Concept * Rash as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, Skin and subcutaneous tissue disorders Timings - Text * 12 weeks Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-34-EG000 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_34_EG000 title: Dizziness as other adverse event for QUARTET LDQT in NCT03640312 status: Active variableDefinition description: QUARTET LDQT variableRole: Population observed: Patients randomized to the intervention arm will take a once daily ultra-low-dose quadruple combination therapy (QUARTET LDQT). The LDQT is an overencapsulated combination pill comprising four types of blood pressure lowering medications each at ¼ standard doses. QUARTET includes candesartan 2mg, amlodipine besylate 1.25mg, indapamide 0.625mg, and bisoprolol 2.5mg. The individual components are currently approved and marketed within the United States. QUARTET LDQT: Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Dizziness as other adverse event statistic statisticType: Percentage quantity: 0.125 numberOfEvents: 4 numberAffected: 4 SampleSizes - KnownDataCount * 32 Generated Narrative: Evidence #NCT03640312-OtherAdverseEvent-34-EG001 Profile: NonComparativeEvidence name: NCT03640312_OtherAdverseEvent_34_EG001 title: Dizziness as other adverse event for Candesartan in NCT03640312 status: Active variableDefinition description: Candesartan variableRole: Population observed: Patients randomized to the comparison arm will take a once daily 8mg candesartan. Candesartan: Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks. variableDefinition note: Same as clinicaltrials.gov definition. A known side effects checklist (included in protocol and consent) was used as a dropdown list for site staff to populate as appropriate at each participant encounter. Any reported side effects from this list were documented as an AE. If an AE did not meet any of these pre-specified terms, the site staff would document 'other' and specify. At specified intervals, a blinded third party MedDRA coder would enter the MedDRA terms into the safety database. variableRole: Outcome observed: EvidenceVariable Dizziness as other adverse event statistic statisticType: Percentage quantity: 0.03333333333333333 numberOfEvents: 1 numberAffected: 1 SampleSizes - KnownDataCount * 30 Generated Narrative: EvidenceVariable #NCT03640312-OtherAdverseEvent-34 Profile: VariableDefinition title: Dizziness as other adverse event status: Active note: 5 total Feeling faint/lightheadedness/falling (5/5), mild (4/5) moderate (1/5), resolved without sequelae (5/5), unlikely relatedness (2/5) possible (3/5), no IP action taken (5/5) Definitions - Concept * Dizziness as other adverse event definitionModifier code: Adverse event assessment type value: Systematic Assessment definitionModifier code: Source Vocabulary for Adverse Event Definition value: MedDRA 23.0 handling: boolean variable classifier: Other Adverse Event, Vascular disorders Timings - Text * 12 weeks
All-cause mortality (timeframe for NCT03640312)
Serious Adverse Events (timeframe for NCT03640312)
Other Adverse Events (timeframe for NCT03640312)
All-cause mortality for QUARTET LDQT in NCT03640312
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.
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.
Serious Adverse Events for QUARTET LDQT in NCT03640312
Other Adverse Events for QUARTET LDQT in NCT03640312
All-cause mortality for Candesartan in NCT03640312
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.
Serious Adverse Events for Candesartan in NCT03640312
Other Adverse Events for Candesartan in NCT03640312
Road Traffic Accident as serious adverse event for QUARTET LDQT in NCT03640312
Road Traffic Accident as serious adverse event for Candesartan in NCT03640312
Road Traffic Accident as serious adverse event
Motor Vehicle Accident. Severity: Severe. Outcome: Resolved with sequelae. Blinded relatedness assessment: Unrelated. Investigational product action taken: Temporarily Withdrawn. Resulted in hospitalization.
Source Vocabulary for Adverse Event Definition
Injury, poisoning and procedural complications
Chest Pain as serious adverse event for QUARTET LDQT in NCT03640312
Chest Pain as serious adverse event for Candesartan in NCT03640312
Severity: Severe. Outcome: Resolved with Sequelae. Relatedness Assessment: Unrelated. Investigational Product action taken: Temporarily Withdrawn. Resulted in hospitalization.
Vision blurred as other adverse event for QUARTET LDQT in NCT03640312
Vision blurred as other adverse event for Candesartan in NCT03640312
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
Palpitations as other adverse event for QUARTET LDQT in NCT03640312
Palpitations as other adverse event for Candesartan in NCT03640312
Palpitations, mild, resolved without sequelae, possible relatedness, no IP action taken.
Tinnitus as other adverse event for QUARTET LDQT in NCT03640312
Tinnitus as other adverse event for Candesartan in NCT03640312
Ringing in ears, mild, ongoing at study exit, assessed unrelated, no IP action taken.
Eye pruritis as other adverse event for QUARTET LDQT in NCT03640312
Eye pruritis as other adverse event for Candesartan in NCT03640312
Itchy eyes, mild, resolved without sequelae, unlikely relatedness, no IP action taken
Diarrhea as other adverse event for QUARTET LDQT in NCT03640312
Diarrhea as other adverse event for Candesartan in NCT03640312
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).
Abdominal pain upper as other adverse event for QUARTET LDQT in NCT03640312
Abdominal pain upper as other adverse event for Candesartan in NCT03640312
Abdominal pain upper as other adverse event
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)
Dry Mouth as other adverse event for QUARTET LDQT in NCT03640312
Dry Mouth as other adverse event for Candesartan in NCT03640312
mild, resolved without sequelae, unrelated, no IP action taken
Constipation as other adverse event for QUARTET LDQT in NCT03640312
Constipation as other adverse event for Candesartan in NCT03640312
Throat irritation as other adverse event for QUARTET LDQT in NCT03640312
Throat irritation as other adverse event for Candesartan in NCT03640312
Throat irritation as other adverse event
mild, resolved without sequelae, possible relatedness, no IP action taken
Nausea as other adverse event for QUARTET LDQT in NCT03640312
Nausea as other adverse event for Candesartan in NCT03640312
Nausea/vomiting, mild, resolved without sequelae, possible relatedness, permanently discontinued
Dry throat as other adverse event for QUARTET LDQT in NCT03640312
Dry throat as other adverse event for Candesartan in NCT03640312
mild, resolved without sequelae, possible relatedness, temporarily withdrawn
Vomiting as other adverse event for QUARTET LDQT in NCT03640312
Vomiting as other adverse event for Candesartan in NCT03640312
Nausea/Vomiting, mild, resolved without sequelae, unrelated, temporarily withdrawn
Feeling Hot as other adverse event for QUARTET LDQT in NCT03640312
Feeling Hot as other adverse event for Candesartan in NCT03640312
Feeling warm, moderate, resolved without sequelae, possible relatedness, permanently discontinued
Influenza like illness as other adverse event for QUARTET LDQT in NCT03640312
Influenza like illness as other adverse event for Candesartan in NCT03640312
Influenza like illness as other adverse event
Flu-like symptoms, moderate, ongoing at study exit, unrelated, no IP action taken
Fatigue as other adverse event for QUARTET LDQT in NCT03640312
Fatigue as other adverse event for Candesartan in NCT03640312
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)
Peripheral swelling as other adverse event for QUARTET LDQT in NCT03640312
Peripheral swelling as other adverse event for Candesartan in NCT03640312
Peripheral swelling as other adverse event
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)
Chest Pain as other adverse event for QUARTET LDQT in NCT03640312
Chest Pain as other adverse event for Candesartan in NCT03640312
Asthenia as other adverse event for QUARTET LDQT in NCT03640312
Asthenia as other adverse event for Candesartan in NCT03640312
Pain as other adverse event for QUARTET LDQT in NCT03640312
Pain as other adverse event for Candesartan in NCT03640312
Body aches, mild, resolved without sequelae, unrelated, temporarily withdrawn
Blood glucose increased as other adverse event for QUARTET LDQT in NCT03640312
Blood glucose increased as other adverse event for Candesartan in NCT03640312
Blood glucose increased as other adverse event
Elevated blood sugar, mild, ongoing at study exit, unlikely relatedness, no IP action taken
Heart rate irregular as other adverse event for QUARTET LDQT in NCT03640312
Heart rate irregular as other adverse event for Candesartan in NCT03640312
Heart rate irregular as other adverse event
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)
Back pain as other adverse event for QUARTET LDQT in NCT03640312
Back pain as other adverse event for Candesartan in NCT03640312
mild, ongoing at study exit, unlikely relatedness, no IP action taken
Musculoskeletal and connective tissue disorders
Muscle cramps/spasms as other adverse event for QUARTET LDQT in NCT03640312
Muscle cramps/spasms as other adverse event for Candesartan in NCT03640312
Muscle cramps/spasms as other adverse event
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)
Headache as other adverse event for QUARTET LDQT in NCT03640312
Headache as other adverse event for Candesartan in NCT03640312
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)
Dizziness as other adverse event for QUARTET LDQT in NCT03640312
Dizziness as other adverse event for Candesartan in NCT03640312
2 total mild (2/2), resolved without sequelae (2/2), possible relatedness (2/2), no IP action taken (2/2)
Blurred vision/vision or hearing changes, mild, resolved without sequelae, unlikely relatedness, permanently discontinued
Hypoaesthesia as other adverse event for QUARTET LDQT in NCT03640312
Hypoaesthesia as other adverse event for Candesartan in NCT03640312
cold/tingling/numb hands/feet, mild, resolved without sequelae, unrelated, no IP action taken
Anxiety as other adverse event for QUARTET LDQT in NCT03640312
Anxiety as other adverse event for Candesartan in NCT03640312
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)
Nasopharyngitis as other adverse event for QUARTET LDQT in NCT03640312
Nasopharyngitis as other adverse event for Candesartan in NCT03640312
Cold symptoms, mild, ongoing at study exit, unrelated, no IP action taken
Respiratory, thoracic and mediastinal disorders
Cough as other adverse event for QUARTET LDQT in NCT03640312
Cough as other adverse event for Candesartan in NCT03640312
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)
Dyspnea as other adverse event for QUARTET LDQT in NCT03640312
Dyspnea as other adverse event for Candesartan in NCT03640312
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)
Respiration Abnormal as other adverse event for QUARTET LDQT in NCT03640312
Respiration Abnormal as other adverse event for Candesartan in NCT03640312
Respiration Abnormal as other adverse event
Breathing problem, severe, resolved without sequelae, unlikely relatedness, no IP action taken
Hyperhidrosis as other adverse event for QUARTET LDQT in NCT03640312
Hyperhidrosis as other adverse event for Candesartan in NCT03640312
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)
Rash as other adverse event for QUARTET LDQT in NCT03640312
Rash as other adverse event for Candesartan in NCT03640312
Rash, mild, resolved without sequelae, unlikely relatedness, no IP action taken
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)
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.
12 weeks