TriangleNCT00773747 · OUTCOME
Overall Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Events/100-person Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization up to 32 months (final study analysis)
What was measured
Overall survival was measured from the start of the treatment to death due to any cause. Overall Survival is represented as the number of deaths per 100-person- months and was computed by dividing the number of participants with an event of death that occurred during the study follow-up period by the total duration of follow-up (in 100 months) for all the participants in each cohort since participants had different lengths of follow-up.
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 | 1.7 | 1.56 | 1.56 | 1.84 | Not reported |
| Placebo + Bortezomib | 1.9 | 1.75 | 1.75 | 2.05 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.622
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.184
- 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
- 0.3496
- param Type
- Cox Proportional Hazard
- param Value
- 0.858
- statistical Method
- Regression, Cox
Complete source fields
- analyses
- ci Lower Limit
- 0.622
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.184
- 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
- 0.3496
- param Type
- Cox Proportional Hazard
- param Value
- 0.858
- statistical Method
- Regression, Cox
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.56
- spread
- 1.56
- upper Limit
- 1.84
- value
- 1.7
- group Id
- OG001
- lower Limit
- 1.75
- spread
- 1.75
- upper Limit
- 2.05
- value
- 1.9
- denoms
- counts
- group Id
- OG000
- value
- 317
- group Id
- OG001
- value
- 320
- units
- Participants
- description
- Overall survival was measured from the start of the treatment to death due to any cause. Overall Survival is represented as the number of deaths per 100-person- months and was computed by dividing the number of participants with an event of death that occurred during the study follow-up period by the total duration of follow-up (in 100 months) for all the participants in each cohort since participants had different lengths of follow-up.
- 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
- NUMBER
- population Description
- The analysis population includes all randomized participants.
- reporting Status
- POSTED
- time Frame
- From randomization up to 32 months (final study analysis)
- title
- Overall Survival
- type
- SECONDARY
- unit Of Measure
- Events/100-person Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice