TriangleNCT01938001 · OUTCOME
Kaplan Meier Estimate of Event Free Survival as Assessed by the IRC According to the 2007 IWGRC
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
- From date of randomization to data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months).
What was measured
Event-free survival (EFS) was defined as the time from date of randomization to date of first documented progression, relapse, institution of new anti-lymphoma treatment (chemotherapy, radiotherapy or immunotherapy) or death from any cause. Responding participants and those who were lost to follow up were censored at their last tumor assessment date.
Analysis population: The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.
Groups in this outcome
Rituximab + Lenalidomide (R^2)
Participants received rituximab 375 mg/m\^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but \< 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.
Rituximab + Placebo
Participants received rituximab 375 mg/m\^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
| Group | Source count |
|---|---|
| Rituximab + Lenalidomide (R^2) | 178 |
| Rituximab + Placebo | 180 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab + Lenalidomide (R^2) | 27.6 | Not reported | 22.1 | NA | Not enough events had occurred at the time of the data cut-off date |
| Rituximab + Placebo | 13.9 | Not reported | 11.4 | 16.7 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.38
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.67
- estimate Comment
- Hazard ratio and its CI were estimated from Cox proportional hazard model adjusting for the stratification factors noted above.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.51
- statistical Comment
- Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).
- statistical Method
- Stratified Log-Rank Test
Complete source fields
- analyses
- ci Lower Limit
- 0.38
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.67
- estimate Comment
- Hazard ratio and its CI were estimated from Cox proportional hazard model adjusting for the stratification factors noted above.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.51
- statistical Comment
- Stratified by 3 factors: previous rituximab treatment, time since last antilymphoma therapy (≤ 2, \> 2 years), and disease histology (FL, MZL).
- statistical Method
- Stratified Log-Rank Test
- classes
- categories
- measurements
- comment
- Not enough events had occurred at the time of the data cut-off date
- group Id
- OG000
- lower Limit
- 22.1
- upper Limit
- NA
- value
- 27.6
- group Id
- OG001
- lower Limit
- 11.4
- upper Limit
- 16.7
- value
- 13.9
- denoms
- counts
- group Id
- OG000
- value
- 178
- group Id
- OG001
- value
- 180
- units
- Participants
- description
- Event-free survival (EFS) was defined as the time from date of randomization to date of first documented progression, relapse, institution of new anti-lymphoma treatment (chemotherapy, radiotherapy or immunotherapy) or death from any cause. Responding participants and those who were lost to follow up were censored at their last tumor assessment date.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received rituximab 375 mg/m\^2 intravenously (IV) every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from Cycles 2 to 5 plus lenalidomide 20 mg by mouth (PO) once daily on Days 1 to 21 every 28 days up to 12 cycles (21-day treatment and 7-day rest period); if creatinine clearance (CrCl) was ≥ 30 mL/min but \< 60 mL/min, participants received lenalidomide 10 mg capsules on days 1 to 21 every 28 days.
- id
- OG000
- title
- Rituximab + Lenalidomide (R^2)
- description
- Participants received rituximab 375 mg/m\^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) and on Day 1 of every 28-day cycle from cycle 2 to 5 plus placebo (identically matched capsule) once daily on Days 1 to 21 of every 28-day cycle up to 12 cycles.
- id
- OG001
- title
- Rituximab + Placebo
- param Type
- MEDIAN
- population Description
- The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.
- reporting Status
- POSTED
- time Frame
- From date of randomization to data cut-off date of 22 June 2018; overall median follow-up time for all participants was 28.30 months (range: 0.1 to 51.3 months).
- title
- Kaplan Meier Estimate of Event Free Survival as Assessed by the IRC According to the 2007 IWGRC
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice