TriangleNCT01088984 · OUTCOME
Best Overall Tumor Response Rate, by Phase
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
- At each treatment cycle (21 to 35 days), for a maximum of 12 cycles
What was measured
Biological activity of bendamustine was defined as achieving a best response of partial response (PR), CRp, or CR. Rate was calculated as follows: number of participants in the primary analysis set achieving a best overall response of PR, CRp, or CR, divided by the number of participants in the primary analysis set. The most positive response for each patient during the study was counted. The 95% CI was calculated using binomial parameter exact method. Response was determined by the investigator, and evaluated per Jeha et al, 2006: A PR had to meet the following criteria: complete disappearance of circulating blasts and an M2 marrow (≥ 5% and ≤ 25% bone marrow blasts) and appearance of normal progenitor cells or an M1 marrow that did not qualify for CR or CRp. See Outcome Measure 2 for full definitions for CRp and CR.
Analysis population: The safety analysis set included all participants treated at any dose of bendamustine.
Groups in this outcome
Phase 1: Bendamustine 90 or 120 mg/m^2
Bendamustine 90 or 120 mg/m\^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of a 21-day Induction Cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
Phase 2: Bendamustine 120 mg/m^2
Bendamustine 120 mg/m\^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
Total
Bendamustine 90 or 120 mg/m\^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
| Group | Source count |
|---|---|
| Phase 1: Bendamustine 90 or 120 mg/m^2 | 11 |
| Phase 2: Bendamustine 120 mg/m^2 | 32 |
| Total | 43 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Bendamustine 90 or 120 mg/m^2 | 18 | Not reported | 2.28 | 51.78 | Not reported |
| Phase 2: Bendamustine 120 mg/m^2 | 6 | Not reported | 0.77 | 20.81 | Not reported |
| Total | 9 | Not reported | 2.59 | 22.14 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.28
- upper Limit
- 51.78
- value
- 18
- group Id
- OG001
- lower Limit
- 0.77
- upper Limit
- 20.81
- value
- 6
- group Id
- OG002
- lower Limit
- 2.59
- upper Limit
- 22.14
- value
- 9
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 32
- group Id
- OG002
- value
- 43
- units
- Participants
- description
- Biological activity of bendamustine was defined as achieving a best response of partial response (PR), CRp, or CR. Rate was calculated as follows: number of participants in the primary analysis set achieving a best overall response of PR, CRp, or CR, divided by the number of participants in the primary analysis set. The most positive response for each patient during the study was counted. The 95% CI was calculated using binomial parameter exact method. Response was determined by the investigator, and evaluated per Jeha et al, 2006: A PR had to meet the following criteria: complete disappearance of circulating blasts and an M2 marrow (≥ 5% and ≤ 25% bone marrow blasts) and appearance of normal progenitor cells or an M1 marrow that did not qualify for CR or CRp. See Outcome Measure 2 for full definitions for CRp and CR.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Bendamustine 90 or 120 mg/m\^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of a 21-day Induction Cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
- id
- OG000
- title
- Phase 1: Bendamustine 90 or 120 mg/m^2
- description
- Bendamustine 120 mg/m\^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
- id
- OG001
- title
- Phase 2: Bendamustine 120 mg/m^2
- description
- Bendamustine 90 or 120 mg/m\^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
- id
- OG002
- title
- Total
- param Type
- NUMBER
- population Description
- The safety analysis set included all participants treated at any dose of bendamustine.
- reporting Status
- POSTED
- time Frame
- At each treatment cycle (21 to 35 days), for a maximum of 12 cycles
- title
- Best Overall Tumor Response Rate, by Phase
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice