TriangleNCT01564537 · OUTCOME
Time to Progression (TTP) as Assessed by the IRC
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 of each cycle (every 4 weeks) until disease progression up to approximately 27 months (approximate median follow-up 15 months)
What was measured
TTP was measured as the time in months from the first dose of study treatment to the date of the first documented progressive disease (PD) as assessed by the IRC using IMWG criteria.
Analysis population: ITT population included all randomized participants
Groups in this outcome
Ixazomib+ Lenalidomide + Dexamethasone
Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first up to EOT (up to approximately 42.9 months).
Placebo + Lenalidomide + Dexamethasone
Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first (up to approximately 41 months).
| Group | Source count |
|---|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 360 |
| Placebo + Lenalidomide + Dexamethasone | 362 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ixazomib+ Lenalidomide + Dexamethasone | 22.4 | Not reported | 18.73 | 27.66 | Not reported |
| Placebo + Lenalidomide + Dexamethasone | 17.6 | Not reported | 14.52 | 20.27 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 18.73
- upper Limit
- 27.66
- value
- 22.4
- group Id
- OG001
- lower Limit
- 14.52
- upper Limit
- 20.27
- value
- 17.6
- denoms
- counts
- group Id
- OG000
- value
- 360
- group Id
- OG001
- value
- 362
- units
- Participants
- description
- TTP was measured as the time in months from the first dose of study treatment to the date of the first documented progressive disease (PD) as assessed by the IRC using IMWG criteria.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first up to EOT (up to approximately 42.9 months).
- id
- OG000
- title
- Ixazomib+ Lenalidomide + Dexamethasone
- description
- Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first (up to approximately 41 months).
- id
- OG001
- title
- Placebo + Lenalidomide + Dexamethasone
- param Type
- MEDIAN
- population Description
- ITT population included all randomized participants
- reporting Status
- POSTED
- time Frame
- Day 1 of each cycle (every 4 weeks) until disease progression up to approximately 27 months (approximate median follow-up 15 months)
- title
- Time to Progression (TTP) as Assessed by the IRC
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice