TriangleNCT02165397 · OUTCOME
Overall Survival (OS) - Kaplan Meier Landmark Estimates at Month 54
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
- Month 54 (median time on study: 49.7 months [Ibr+R and Pbo+R] and 57.9 months [Open-Label Ibr])
What was measured
OS, defined as the time from the date of randomization to the date of death from any cause. All deaths observed as the time of the analysis were considered as events. For participants who were not known to have died at the time of the analysis, OS data were censored at the date last known alive. As the median OS was not reached in any treatment arm at the time of the analysis, Kaplan Meier point estimates of the OS rate (that is, the estimated percentage of participants still surviving at Month 54) are presented.
Analysis population: Intent to Treat population: all randomized/enrolled participants
Groups in this outcome
Ibrutinib + Rituximab
Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Rituximab: 375 mg/m\^2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab.
Placebo + Rituximab
Placebo: 3 capsules of placebo orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Rituximab: 375 mg/m\^2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab.
Open-Label Substudy: Ibrutinib
Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Participants (rituximab refractory) were treated in an open-label substudy independently of the 2 randomized main treatment arms.
| Group | Source count |
|---|---|
| Ibrutinib + Rituximab | 75 |
| Placebo + Rituximab | 75 |
| Open-Label Substudy: Ibrutinib | 31 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ibrutinib + Rituximab | 86.4 | Not reported | 73.7 | 93.3 | Not reported |
| Placebo + Rituximab | 84.2 | Not reported | 71.3 | 91.6 | Not reported |
| Open-Label Substudy: Ibrutinib | 73.4 | Not reported | 53.7 | 85.7 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.328
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.99
- estimate Comment
- Hazard ratio is estimated using unstratified Cox regression model with treatment as the only covariate.
- group Description
- Data cutoff 18 December 2019
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.643
- p Value Comment
- P-value is from unstratified log rank test.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.808
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.328
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.99
- estimate Comment
- Hazard ratio is estimated using unstratified Cox regression model with treatment as the only covariate.
- group Description
- Data cutoff 18 December 2019
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.643
- p Value Comment
- P-value is from unstratified log rank test.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.808
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 73.7
- upper Limit
- 93.3
- value
- 86.4
- group Id
- OG001
- lower Limit
- 71.3
- upper Limit
- 91.6
- value
- 84.2
- group Id
- OG002
- lower Limit
- 53.7
- upper Limit
- 85.7
- value
- 73.4
- denoms
- counts
- group Id
- OG000
- value
- 75
- group Id
- OG001
- value
- 75
- group Id
- OG002
- value
- 31
- units
- Participants
- description
- OS, defined as the time from the date of randomization to the date of death from any cause. All deaths observed as the time of the analysis were considered as events. For participants who were not known to have died at the time of the analysis, OS data were censored at the date last known alive. As the median OS was not reached in any treatment arm at the time of the analysis, Kaplan Meier point estimates of the OS rate (that is, the estimated percentage of participants still surviving at Month 54) are presented.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Rituximab: 375 mg/m\^2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab.
- id
- OG000
- title
- Ibrutinib + Rituximab
- description
- Placebo: 3 capsules of placebo orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Rituximab: 375 mg/m\^2 IV per package insert weekly for four consecutive weeks (Day 1 of Weeks 1-4), followed by a second four-weekly rituximab course after a three-month interval (Weeks 17-20) for a total of 8 infusions of rituximab.
- id
- OG001
- title
- Placebo + Rituximab
- description
- Ibrutinib: 420 mg (3 capsules) orally administered daily beginning from Day 1 in Week 1 until progression, discontinuation due to toxicity or other reasons to discontinue treatment. Participants (rituximab refractory) were treated in an open-label substudy independently of the 2 randomized main treatment arms.
- id
- OG002
- title
- Open-Label Substudy: Ibrutinib
- param Type
- NUMBER
- population Description
- Intent to Treat population: all randomized/enrolled participants
- reporting Status
- POSTED
- time Frame
- Month 54 (median time on study: 49.7 months [Ibr+R and Pbo+R] and 57.9 months [Open-Label Ibr])
- title
- Overall Survival (OS) - Kaplan Meier Landmark Estimates at Month 54
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice