TriangleNCT03859427 · OUTCOME
Kaplan-Meier Estimate of Overall Survival (OS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Cycle 1 Day 1 up to approximately 12 months (cycle = 28 days); median treatment duration for the twice-weekly arm was 47.00 weeks and for the once-weekly arm was 47.14 weeks.
What was measured
OS was defined as the time from randomization to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method. 95% CIs were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. Participants still alive or lost to follow-up or withdrawn consent from study by the analysis time were censored at the date on which the participant was last known to be alive.
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 | NA | Not reported | NA | NA | The median and 95% CIs could not be estimated due to too few events. |
| Once-weekly KRd 20/56 mg/m^2 | NA | Not reported | NA | NA | The median and 95% CIs could not be estimated due to too few events. |
Complete source fields
- classes
- categories
- measurements
- comment
- The median and 95% CIs could not be estimated due to too few events.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- The median and 95% CIs could not be estimated due to too few events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 226
- group Id
- OG001
- value
- 228
- units
- Participants
- description
- OS was defined as the time from randomization to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method. 95% CIs were estimated using the method by Klein and Moeschberger (1997) with log-log transformation. Participants still alive or lost to follow-up or withdrawn consent from study by the analysis time were censored at the date on which the participant was last known to be alive.
- 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
- MEDIAN
- population Description
- The ITT population included all randomized participants.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1 up to approximately 12 months (cycle = 28 days); median treatment duration for the twice-weekly arm was 47.00 weeks and for the once-weekly arm was 47.14 weeks.
- title
- Kaplan-Meier Estimate of Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice