TriangleNCT04191616 · 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
- 90% Confidence Interval
- Time frame
- From day 1 cycle 1 until the EOS; the mean duration of KPd treatment was 55.3 weeks.
What was measured
OS was defined as the time from the start of treatment until death from any cause. Medians and percentiles were estimated using the Kaplan-Meier method. 90% CIs for medians were estimated using the method by Klein and Moeschberger (1997) with log-log transformation.
Analysis population: The safety analysis set included all participants who received at least 1 dose of carfilzomib.
Groups in this outcome
Carfilzomib With Pomalidomide and Dexamethasone (KPd)
Carfilzomib was administered intravenously on days 1, 8, and 15 (± 2 days) of each 28-day cycle for up to 12 cycles or progression or end of study. A dose of 20 mg/m\^2 was administered on day 1 of cycle 1; all subsequent doses were 56 mg/m\^2. From cycle 13, the frequency of carfilzomib administration was reduced to days 1 and 15 (± 2 days) per cycle until progression or end of study. Dexamethasone was administered orally or intravenously at a dose of 40 mg on days 1, 8, 15, and 22 of each cycle during cycles 1 to 12, and at a dose of 20 mg on days 1 and 15 from cycle 13 until progression or end of study. Pomalidomide 4 mg was administered orally on days 1 to 21 of each cycle until progression or end of study.
| Group | Source count |
|---|---|
| Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 52 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib With Pomalidomide and Dexamethasone (KPd) | 17.6 | Not reported | 11.2 | 23.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.2
- upper Limit
- 23.5
- value
- 17.6
- denoms
- counts
- group Id
- OG000
- value
- 52
- units
- Participants
- description
- OS was defined as the time from the start of treatment until death from any cause. Medians and percentiles were estimated using the Kaplan-Meier method. 90% CIs for medians were estimated using the method by Klein and Moeschberger (1997) with log-log transformation.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Carfilzomib was administered intravenously on days 1, 8, and 15 (± 2 days) of each 28-day cycle for up to 12 cycles or progression or end of study. A dose of 20 mg/m\^2 was administered on day 1 of cycle 1; all subsequent doses were 56 mg/m\^2. From cycle 13, the frequency of carfilzomib administration was reduced to days 1 and 15 (± 2 days) per cycle until progression or end of study. Dexamethasone was administered orally or intravenously at a dose of 40 mg on days 1, 8, 15, and 22 of each cycle during cycles 1 to 12, and at a dose of 20 mg on days 1 and 15 from cycle 13 until progression or end of study. Pomalidomide 4 mg was administered orally on days 1 to 21 of each cycle until progression or end of study.
- id
- OG000
- title
- Carfilzomib With Pomalidomide and Dexamethasone (KPd)
- param Type
- MEDIAN
- population Description
- The safety analysis set included all participants who received at least 1 dose of carfilzomib.
- reporting Status
- POSTED
- time Frame
- From day 1 cycle 1 until the EOS; the mean duration of KPd treatment was 55.3 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