TriangleNCT00773747 · OUTCOME
Objective Response Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- 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
Objective response rate was measured as the proportion of patients who achieved a confirmed partial response or better during the course of the study. Response to study therapy was assessed using EBMT Criteria and confirmed by Independent Adjudication Review.
Analysis population: The analysis population includes all randomized participants who received ≥1 dose of study medication.
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 | 315 |
| Placebo + Bortezomib | 320 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Vorinostat + Bortezomib | 56.2 | 50.5 | 50.5 | 61.7 | Not reported |
| Placebo + Bortezomib | 40.6 | 35.2 | 35.2 | 46.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 50.5
- spread
- 50.5
- upper Limit
- 61.7
- value
- 56.2
- group Id
- OG001
- lower Limit
- 35.2
- spread
- 35.2
- upper Limit
- 46.2
- value
- 40.6
- denoms
- counts
- group Id
- OG000
- value
- 315
- group Id
- OG001
- value
- 320
- units
- Participants
- description
- Objective response rate was measured as the proportion of patients who achieved a confirmed partial response or better during the course of the study. Response to study therapy was assessed using EBMT Criteria and confirmed by Independent Adjudication Review.
- 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 who received ≥1 dose of study medication.
- reporting Status
- POSTED
- time Frame
- Baseline and at the end of each 21-day Cycle assessed up to 32 months (final study analysis)
- title
- Objective Response Rate
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice