TriangleNCT01059630 · OUTCOME
Percentage of Participants With BOR at the End of Induction Treatment as Assessed by 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
- Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1)
What was measured
BOR: best response for a participant, observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present, SD: Failing to attain criteria needed for a CR or PR, but not fulfilling those for PD, PD: appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules).
Analysis population: ITT population. Here, number of participants analyzed signified those participants who had reached the end of induction treatment response assessment.
Groups in this outcome
Bendamustine Alone
Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
Obinutuzumab + Bendamustine
Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
| Group | Source count |
|---|---|
| Bendamustine Alone | 209 |
| Obinutuzumab + Bendamustine | 204 |
Reported measurements
CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bendamustine Alone | 15.8 | Not reported | 11.12 | 21.45 | Not reported |
| Obinutuzumab + Bendamustine | 17.2 | Not reported | 12.25 | 23.04 | Not reported |
PR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bendamustine Alone | 53.1 | Not reported | 46.10 | 60.03 | Not reported |
| Obinutuzumab + Bendamustine | 60.3 | Not reported | 53.23 | 67.06 | Not reported |
SD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bendamustine Alone | 4.3 | Not reported | 1.99 | 8.02 | Not reported |
| Obinutuzumab + Bendamustine | 3.9 | Not reported | 1.71 | 7.58 | Not reported |
PD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bendamustine Alone | 12.0 | Not reported | 7.89 | 17.15 | Not reported |
| Obinutuzumab + Bendamustine | 9.3 | Not reported | 5.70 | 14.16 | Not reported |
Unable to Evaluate
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bendamustine Alone | 2.9 | Not reported | 1.06 | 6.14 | Not reported |
| Obinutuzumab + Bendamustine | 0.5 | Not reported | 0.01 | 2.70 | Not reported |
Missing
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bendamustine Alone | 12.0 | Not reported | 7.89 | 17.15 | Not reported |
| Obinutuzumab + Bendamustine | 8.8 | Not reported | 5.31 | 13.59 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.12
- upper Limit
- 21.45
- value
- 15.8
- group Id
- OG001
- lower Limit
- 12.25
- upper Limit
- 23.04
- value
- 17.2
- title
- CR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 46.10
- upper Limit
- 60.03
- value
- 53.1
- group Id
- OG001
- lower Limit
- 53.23
- upper Limit
- 67.06
- value
- 60.3
- title
- PR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.99
- upper Limit
- 8.02
- value
- 4.3
- group Id
- OG001
- lower Limit
- 1.71
- upper Limit
- 7.58
- value
- 3.9
- title
- SD
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.89
- upper Limit
- 17.15
- value
- 12.0
- group Id
- OG001
- lower Limit
- 5.70
- upper Limit
- 14.16
- value
- 9.3
- title
- PD
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.06
- upper Limit
- 6.14
- value
- 2.9
- group Id
- OG001
- lower Limit
- 0.01
- upper Limit
- 2.70
- value
- 0.5
- title
- Unable to Evaluate
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.89
- upper Limit
- 17.15
- value
- 12.0
- group Id
- OG001
- lower Limit
- 5.31
- upper Limit
- 13.59
- value
- 8.8
- title
- Missing
- denoms
- counts
- group Id
- OG000
- value
- 209
- group Id
- OG001
- value
- 204
- units
- Participants
- description
- BOR: best response for a participant, observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present, SD: Failing to attain criteria needed for a CR or PR, but not fulfilling those for PD, PD: appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
- id
- OG000
- title
- Bendamustine Alone
- description
- Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
- id
- OG001
- title
- Obinutuzumab + Bendamustine
- param Type
- NUMBER
- population Description
- ITT population. Here, number of participants analyzed signified those participants who had reached the end of induction treatment response assessment.
- reporting Status
- POSTED
- time Frame
- Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1)
- title
- Percentage of Participants With BOR at the End of Induction Treatment as Assessed by Investigator
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Independent clinical review pending · Not medical advice