TriangleNCT00773747 · OUTCOME
Time to Progression
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
- Baseline and at the end of each 21-day Cycle assessed up to 32 months (final study analysis)
What was measured
Time to progression was measured from the start of the treatment to the time when the criteria for progression was met or death due to myeloma (whichever is first recorded). Response to study therapy was assessed using European Blood and Marrow Transplantation Group (EBMT) Criteria. A stratified Cox proportional hazards model was used with Efron's likelihood approximation to account for ties in event times.
Analysis population: The analysis population includes all randomized participants.
Groups in this outcome
Vorinostat + Bortezomib
Participants will receive vorinostat four 100 mg capsules (400 mg total) orally 0-30 minutes after a meal on Days 1 through 14 of a 21-day treatment cycle and bortezomib 1.3 mg/m\^2 by intravenous injection on Days 1, 4, 8, and 11 of a 21-day treatment cycle.
Placebo + Bortezomib
Participants will receive four placebo capsules orally 0-30 minutes after a meal on Days 1 through 14 of a 21-day treatment cycle and bortezomib 1.3 mg/m\^2 by intravenous injection on Days 1, 4, 8, and 11 of a 21-day treatment cycle.
| Group | Source count |
|---|---|
| Vorinostat + Bortezomib | 317 |
| Placebo + Bortezomib | 320 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vorinostat + Bortezomib | 7.73 | 7.00 | 7.00 | 8.53 | Not reported |
| Placebo + Bortezomib | 7.03 | 6.33 | 6.33 | 7.73 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.00
- spread
- 7.00
- upper Limit
- 8.53
- value
- 7.73
- group Id
- OG001
- lower Limit
- 6.33
- spread
- 6.33
- upper Limit
- 7.73
- value
- 7.03
- denoms
- counts
- group Id
- OG000
- value
- 317
- group Id
- OG001
- value
- 320
- units
- Participants
- description
- Time to progression was measured from the start of the treatment to the time when the criteria for progression was met or death due to myeloma (whichever is first recorded). Response to study therapy was assessed using European Blood and Marrow Transplantation Group (EBMT) Criteria. A stratified Cox proportional hazards model was used with Efron's likelihood approximation to account for ties in event times.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants will receive vorinostat four 100 mg capsules (400 mg total) orally 0-30 minutes after a meal on Days 1 through 14 of a 21-day treatment cycle and bortezomib 1.3 mg/m\^2 by intravenous injection on Days 1, 4, 8, and 11 of a 21-day treatment cycle.
- id
- OG000
- title
- Vorinostat + Bortezomib
- description
- Participants will receive four placebo capsules orally 0-30 minutes after a meal on Days 1 through 14 of a 21-day treatment cycle and bortezomib 1.3 mg/m\^2 by intravenous injection on Days 1, 4, 8, and 11 of a 21-day treatment cycle.
- id
- OG001
- title
- Placebo + Bortezomib
- param Type
- MEDIAN
- population Description
- The analysis population includes all randomized participants.
- reporting Status
- POSTED
- time Frame
- Baseline and at the end of each 21-day Cycle assessed up to 32 months (final study analysis)
- title
- Time to Progression
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice