TriangleNCT03859427 · OUTCOME
Percentage of Participants Who Reported Convenience as Measured by the Patient-reported Convenience With Carfilzomib-dosing Schedule Question
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Day 28 of Cycle 4
What was measured
Patient-reported convenience was measured by the Patient-reported Convenience with Carfilzomib-dosing Schedule Question. The items in the questionnaire were categorized as 'Convenient', which included responses of 'Very Convenient' and 'Convenient', and 'Inconvenient' which included responses of 'Inconvenient' and 'Very Inconvenient'. The 95% CIs were estimated using the Clopper-Pearson method.
Analysis population: The ITT population included all randomized participants.
Groups in this outcome
Twice-weekly KRd 20/27 mg/m^2
Carfilzomib was administered twice-weekly intravenously as a 10 ± 5 minute infusion using an infusion pump on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. The dose was 20 mg/m\^2 on Days 1 and 2 of Cycle 1 and 27 mg/m\^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles.
Once-weekly KRd 20/56 mg/m^2
Carfilzomib was administered once-weekly intravenously as a 30 ± 5 minute infusion using an infusion pump on Days 1, 8, and 15 of each 28-day cycle. The dose was 20 mg/m\^2 on Day 1 of Cycle 1 and 56 mg/m\^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles.
| Group | Source count |
|---|---|
| Twice-weekly KRd 20/27 mg/m^2 | 226 |
| Once-weekly KRd 20/56 mg/m^2 | 228 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Twice-weekly KRd 20/27 mg/m^2 | 80.5 | Not reported | 74.8 | 85.5 | Not reported |
| Once-weekly KRd 20/56 mg/m^2 | 81.6 | Not reported | 75.9 | 86.4 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.653
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.683
- estimate Comment
- Odds ratio and 95% CIs were estimated by a stratified analysis using the Cochran-Mantel-Haenszel method.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- param Type
- Odds Ratio (OR)
- param Value
- 1.049
Complete source fields
- analyses
- ci Lower Limit
- 0.653
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.683
- estimate Comment
- Odds ratio and 95% CIs were estimated by a stratified analysis using the Cochran-Mantel-Haenszel method.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- param Type
- Odds Ratio (OR)
- param Value
- 1.049
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 74.8
- upper Limit
- 85.5
- value
- 80.5
- group Id
- OG001
- lower Limit
- 75.9
- upper Limit
- 86.4
- value
- 81.6
- denoms
- counts
- group Id
- OG000
- value
- 226
- group Id
- OG001
- value
- 228
- units
- Participants
- description
- Patient-reported convenience was measured by the Patient-reported Convenience with Carfilzomib-dosing Schedule Question. The items in the questionnaire were categorized as 'Convenient', which included responses of 'Very Convenient' and 'Convenient', and 'Inconvenient' which included responses of 'Inconvenient' and 'Very Inconvenient'. The 95% CIs were estimated using the Clopper-Pearson method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Carfilzomib was administered twice-weekly intravenously as a 10 ± 5 minute infusion using an infusion pump on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. The dose was 20 mg/m\^2 on Days 1 and 2 of Cycle 1 and 27 mg/m\^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles.
- id
- OG000
- title
- Twice-weekly KRd 20/27 mg/m^2
- description
- Carfilzomib was administered once-weekly intravenously as a 30 ± 5 minute infusion using an infusion pump on Days 1, 8, and 15 of each 28-day cycle. The dose was 20 mg/m\^2 on Day 1 of Cycle 1 and 56 mg/m\^2 beginning on Day 8 of Cycle 1 and thereafter. Participants also received lenalidomide 25 mg daily orally on Days 1 to 21 of each cycle and dexamethasone 40 mg weekly orally or intravenously. Participants were treated for up to 12 28-day cycles.
- id
- OG001
- title
- Once-weekly KRd 20/56 mg/m^2
- param Type
- NUMBER
- population Description
- The ITT population included all randomized participants.
- reporting Status
- POSTED
- time Frame
- Day 28 of Cycle 4
- title
- Percentage of Participants Who Reported Convenience as Measured by the Patient-reported Convenience With Carfilzomib-dosing Schedule Question
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice