TriangleNCT01059630 · OUTCOME
Duration of Response (DoR) as Assessed by IRC
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 5 years)
What was measured
DoR: time from first objective response of CR/PR to first occurrence of PD/relapse/death from any cause. CR: Complete disappearance of all detectable evidence of disease \& disease-related symptoms if present before therapy; liver, spleen returned to normal size; if bone marrow involved by lymphoma before treatment, infiltrate must be cleared on repeat bone marrow biopsy. PR: at least 50% measurable disease regressed vs. to baseline scan and no new sites; no increase in size of other nodes/liver/spleen, exception: splenic, hepatic nodules; other organs involved is usually assessable; no measurable disease present. PD: any new lesion \>1.5 cm in any axis appear during or at end of therapy, even if other lesions are decreasing in size; at least 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions. DoR estimated using Kaplan-Meier method. IRC review performed up to clinical cutoff date 1 May 2015.
Analysis population: ITT population. Here, number of participants analyzed signified those participants who had objective response at any time during the study.
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 | 165 |
| Obinutuzumab + Bendamustine | 158 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Bendamustine Alone | 12.7 | Not reported | 10.4 | 14.1 | Not reported |
| Obinutuzumab + Bendamustine | 38.5 | Not reported | 25.4 | NA | Upper limit of 95% confidence interval could not be reached due to low number of participants with events. |
Source statistical analyses
- ci Lower Limit
- 0.31
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.61
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- param Type
- Hazard Ratio (HR)
- param Value
- 0.43
Complete source fields
- analyses
- ci Lower Limit
- 0.31
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.61
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- param Type
- Hazard Ratio (HR)
- param Value
- 0.43
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.4
- upper Limit
- 14.1
- value
- 12.7
- comment
- Upper limit of 95% confidence interval could not be reached due to low number of participants with events.
- group Id
- OG001
- lower Limit
- 25.4
- upper Limit
- NA
- value
- 38.5
- denoms
- counts
- group Id
- OG000
- value
- 165
- group Id
- OG001
- value
- 158
- units
- Participants
- description
- DoR: time from first objective response of CR/PR to first occurrence of PD/relapse/death from any cause. CR: Complete disappearance of all detectable evidence of disease \& disease-related symptoms if present before therapy; liver, spleen returned to normal size; if bone marrow involved by lymphoma before treatment, infiltrate must be cleared on repeat bone marrow biopsy. PR: at least 50% measurable disease regressed vs. to baseline scan and no new sites; no increase in size of other nodes/liver/spleen, exception: splenic, hepatic nodules; other organs involved is usually assessable; no measurable disease present. PD: any new lesion \>1.5 cm in any axis appear during or at end of therapy, even if other lesions are decreasing in size; at least 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions. DoR estimated using Kaplan-Meier method. IRC review performed up to clinical cutoff date 1 May 2015.
- 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 objective response at any time during the study.
- reporting Status
- POSTED
- time Frame
- Baseline until PD or death, whichever occurred first (up to approximately 5 years)
- title
- Duration of Response (DoR) as Assessed by IRC
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice