TriangleNCT01059630 · OUTCOME
Disease-Free Survival (DFS) in Participants With CR as Assessed by Investigator
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline until PD or death, whichever occurred first (up to approximately 8.5 years)
What was measured
DFS was defined as the time from the first occurrence of a documented CR until progression on the basis of the IRC assessments (as per modified response criteria for iNHL \[Modified Cheson et al, 2007\]) or death from any cause on study. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PD: appearance of any new lesion \>1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in a single involved node, or size of other lesions. DFS was estimated using Kaplan-Meier method.
Analysis population: ITT population. Here, number of participants analyzed signified those participants who had an objective response of CR.
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
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bendamustine Alone | 20.0 | Not reported | 8.6 | 31.0 | Not reported |
| Obinutuzumab + Bendamustine | 36.0 | Not reported | 26.6 | 68.2 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.29
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.81
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- param Type
- Hazard Ratio (HR)
- param Value
- 0.48
Complete source fields
- analyses
- ci Lower Limit
- 0.29
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.81
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- param Type
- Hazard Ratio (HR)
- param Value
- 0.48
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.6
- upper Limit
- 31.0
- value
- 20.0
- group Id
- OG001
- lower Limit
- 26.6
- upper Limit
- 68.2
- value
- 36.0
- denoms
- counts
- group Id
- OG000
- value
- 209
- group Id
- OG001
- value
- 204
- units
- Participants
- description
- DFS was defined as the time from the first occurrence of a documented CR until progression on the basis of the IRC assessments (as per modified response criteria for iNHL \[Modified Cheson et al, 2007\]) or death from any cause on study. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PD: appearance of any new lesion \>1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in a single involved node, or size of other lesions. DFS was estimated using Kaplan-Meier method.
- 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
- MEDIAN
- population Description
- ITT population. Here, number of participants analyzed signified those participants who had an objective response of CR.
- reporting Status
- POSTED
- time Frame
- Baseline until PD or death, whichever occurred first (up to approximately 8.5 years)
- title
- Disease-Free Survival (DFS) in Participants With CR as Assessed by Investigator
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice