TriangleNCT00920855 · OUTCOME
Percentage of Participants With An Overall Tumor Response As Assessed By the Investigator
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
- Up to 7.5 months (eight 28-day cycles)
What was measured
Overall tumor response is the sum of a complete response (CR), very good partial response (VGPR), partial response (PR) and minimal response (MR). A modified version of the Bladé criteria for response was used. Abbreviated definitions for the response categories can be found in the description of outcome #3.
Analysis population: Efficacy population
Groups in this outcome
Bendamustine 50 mg/m^2 Cohort
Bortezomib 1.0 mg/m\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
Bendamustine 70 mg/m^2 Cohort
Bortezomib 1.0 mg/m\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
Bendamustine 90 mg/m^2 Cohort
Bortezomib 1.0 mg/m\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
| Group | Source count |
|---|---|
| Bendamustine 50 mg/m^2 Cohort | 5 |
| Bendamustine 70 mg/m^2 Cohort | 4 |
| Bendamustine 90 mg/m^2 Cohort | 31 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bendamustine 50 mg/m^2 Cohort | 40.0 | Not reported | 5.27 | 85.34 | Not reported |
| Bendamustine 70 mg/m^2 Cohort | 25.0 | Not reported | 0.63 | 80.59 | Not reported |
| Bendamustine 90 mg/m^2 Cohort | 51.6 | Not reported | 33.06 | 69.85 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.27
- upper Limit
- 85.34
- value
- 40.0
- group Id
- OG001
- lower Limit
- 0.63
- upper Limit
- 80.59
- value
- 25.0
- group Id
- OG002
- lower Limit
- 33.06
- upper Limit
- 69.85
- value
- 51.6
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 31
- units
- Participants
- description
- Overall tumor response is the sum of a complete response (CR), very good partial response (VGPR), partial response (PR) and minimal response (MR). A modified version of the Bladé criteria for response was used. Abbreviated definitions for the response categories can be found in the description of outcome #3.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Bortezomib 1.0 mg/m\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
- id
- OG000
- title
- Bendamustine 50 mg/m^2 Cohort
- description
- Bortezomib 1.0 mg/m\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
- id
- OG001
- title
- Bendamustine 70 mg/m^2 Cohort
- description
- Bortezomib 1.0 mg/m\^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m\^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
- id
- OG002
- title
- Bendamustine 90 mg/m^2 Cohort
- param Type
- NUMBER
- population Description
- Efficacy population
- reporting Status
- POSTED
- time Frame
- Up to 7.5 months (eight 28-day cycles)
- title
- Percentage of Participants With An Overall Tumor Response As Assessed By the Investigator
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice