TriangleNCT00560352 · OUTCOME
Progression-free Survival
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
- Day 1 to disease progression or death, whichever came first (maximum reached: 14 months)
What was measured
Progression-free survival was defined as the time from start of treatment until progression or death, whichever occurred first. Participants were to be followed-up for 12 months following the last dose of dasatinib for progression and survival. PFS was analyzed for the all-treated population.
Analysis population: All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone
Groups in this outcome
All Treated
Dasatinib taken orally every day, QD or BID, depending on the assigned cohort dose level, in 21-day cycles. In a 21-day cycle, bortezomib was also administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was followed 1-2 hours later by the dose of bortezomib. In the dose-escalation phase (Part 1), participants were enrolled sequentially in groups of 3 and individually assessed for safety and dose-limiting toxicity.
| Group | Source count |
|---|---|
| All Treated | 14 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Treated | 6.3 | Not reported | 2.4 | 14.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.4
- upper Limit
- 14.0
- value
- 6.3
- denoms
- counts
- group Id
- OG000
- value
- 14
- units
- Participants
- description
- Progression-free survival was defined as the time from start of treatment until progression or death, whichever occurred first. Participants were to be followed-up for 12 months following the last dose of dasatinib for progression and survival. PFS was analyzed for the all-treated population.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Dasatinib taken orally every day, QD or BID, depending on the assigned cohort dose level, in 21-day cycles. In a 21-day cycle, bortezomib was also administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was followed 1-2 hours later by the dose of bortezomib. In the dose-escalation phase (Part 1), participants were enrolled sequentially in groups of 3 and individually assessed for safety and dose-limiting toxicity.
- id
- OG000
- title
- All Treated
- param Type
- MEDIAN
- population Description
- All participants who received at least 1 dose of dasatinib and/or bortezomib and/or dexamethasone
- reporting Status
- POSTED
- time Frame
- Day 1 to disease progression or death, whichever came first (maximum reached: 14 months)
- title
- Progression-free Survival
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice