TriangleNCT00773747 · OUTCOME
Progression-Free Survival (PFS)
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
- From randomization to event of disease progression or death assessed up to 32 months (final study analysis)
What was measured
Progression-free survival was measured from the start of the treatment to the time when the criteria for progression was met or death due to any cause (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 | 7.63 | 6.87 | 6.87 | 8.40 | Not reported |
| Placebo + Bortezomib | 6.83 | 5.67 | 5.67 | 7.73 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.636
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.941
- group Description
- Cox model stratified by myeloma stage at enrollment, history of a bone marrow transplant, and number of prior treatment regimens, with a single treatment covariate.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- = 0.0100
- param Type
- Cox Proportional Hazard
- param Value
- 0.774
- statistical Method
- Regression, Cox
Complete source fields
- analyses
- ci Lower Limit
- 0.636
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.941
- group Description
- Cox model stratified by myeloma stage at enrollment, history of a bone marrow transplant, and number of prior treatment regimens, with a single treatment covariate.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- = 0.0100
- param Type
- Cox Proportional Hazard
- param Value
- 0.774
- statistical Method
- Regression, Cox
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.87
- spread
- 6.87
- upper Limit
- 8.40
- value
- 7.63
- group Id
- OG001
- lower Limit
- 5.67
- spread
- 5.67
- upper Limit
- 7.73
- value
- 6.83
- denoms
- counts
- group Id
- OG000
- value
- 317
- group Id
- OG001
- value
- 320
- units
- Participants
- description
- Progression-free survival was measured from the start of the treatment to the time when the criteria for progression was met or death due to any cause (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
- From randomization to event of disease progression or death assessed up to 32 months (final study analysis)
- title
- Progression-Free Survival (PFS)
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice