TriangleNCT03828292 · OUTCOME
Part 2: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Heart Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline (Day 1) and up to approximately 212 weeks
What was measured
Heart rate was measured after resting for at least 5 minutes. The abnormal ranges for heart rate were (low \<60 beats per minute \[bpm\] and high \>100 bpm). Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits. Data for participants with worst case change from baseline was presented as Baseline to low, Baseline to Normal or No change and Baseline to High.
Analysis population: All treated population.
Groups in this outcome
Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter\^2 (m\^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles.
Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression.
| Group | Source count |
|---|---|
| Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | 3 |
| Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | 4 |
Reported measurements
Source class 1
Decrease to Low (<60 bpm)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | 1 | Not reported | Not reported | Not reported | Not reported |
| Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | 1 | Not reported | Not reported | Not reported | Not reported |
Change to Normal or No Change
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | 0 | Not reported | Not reported | Not reported | Not reported |
| Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | 3 | Not reported | Not reported | Not reported | Not reported |
Increase to High (>100 bpm)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex) | 2 | Not reported | Not reported | Not reported | Not reported |
| Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- title
- Decrease to Low (<60 bpm)
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 3
- title
- Change to Normal or No Change
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- title
- Increase to High (>100 bpm)
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- units
- Participants
- description
- Heart rate was measured after resting for at least 5 minutes. The abnormal ranges for heart rate were (low \<60 beats per minute \[bpm\] and high \>100 bpm). Baseline was defined as the latest pre-dose assessment within 21 days prior to first dose with a non-missing value, including those from unscheduled visits. Data for participants with worst case change from baseline was presented as Baseline to low, Baseline to Normal or No change and Baseline to High.
- groups
- description
- Participants with RRMM received belantamab mafodotin as dose of 2.5mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression. Bortezomib was administered subcutaneously (SC) as 1.3 mg/meter\^2 (m\^2) on Day 1, Day 4, Day 8, and Day 11 of every 21-day cycle maximum up to 8 cycles. Dexamethasone was administered orally as dose of 20 mg on Day 1, Day 2, Day 4, Day 5, Day 8, Day 9, Day 11, and Day 12 of every 21-day cycle maximum up to 8 cycles.
- id
- OG000
- title
- Main Study - Part 2: ArmA-Belantamab Mafodotin 2.5 mg/kg + Bortezomib and Dexamethasone (Bor/Dex)
- description
- Participants with RRMM received belantamab mafodotin at a dose of 2.5 mg/kg via IV infusion on Day 1 of each 28-day cycle in cycle 1, and at a dose of 1.9 mg/kg from cycle 2 onwards maximum up to disease progression. Along with belantamab mafodotin, Pomalidomide was administered orally as dose of 4 mg per day on Day 1 to Day 21 of 28-day cycles maximum up to disease progression. Dexamethasone orally as dose of 40 mg per day on Day 1, Day 8, Day 15, and Day 22 of each 28-day maximum up to disease progression.
- id
- OG001
- title
- Main Study - Part2: ArmB- Belantamab Mafodotin 2.5 mg/kg + Pomalidomide and Dexamethasone (Pom/Dex)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All treated population.
- reporting Status
- POSTED
- time Frame
- Baseline (Day 1) and up to approximately 212 weeks
- title
- Part 2: Number of Participants With Worst-case Change Post-baseline in Vital Sign Parameters: Heart Rate
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice