TriangleNCT01938001 · OUTCOME
Kaplan Meier Estimate of Time to Next Anti-Lymphoma Treatment (TTNLT)
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 date of first documented administration of a new anti-lymphoma treatment (Average of 55.71 months and a maximum up to 95.2 months)
What was measured
Time to next anti-lymphoma treatment (TTNLT) was defined as the time from date of randomization to date of first documented administration of a new anti-lymphoma treatment (including chemotherapy, radiotherapy, radioimmunotherapy or immunotherapy). The time to the next anti-lymphoma treatment was of special interest to the study.
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) | 73.1 | Not reported | 43.0 | NA | upper limit not available due to insufficient number of participants with events |
| Rituximab + Placebo | 31.8 | Not reported | 22.2 | 39.4 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.39
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.71
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.53
- 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
- 0.39
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.71
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.53
- 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
- upper limit not available due to insufficient number of participants with events
- group Id
- OG000
- lower Limit
- 43.0
- upper Limit
- NA
- value
- 73.1
- group Id
- OG001
- lower Limit
- 22.2
- upper Limit
- 39.4
- value
- 31.8
- denoms
- counts
- group Id
- OG000
- value
- 178
- group Id
- OG001
- value
- 180
- units
- Participants
- description
- Time to next anti-lymphoma treatment (TTNLT) was defined as the time from date of randomization to date of first documented administration of a new anti-lymphoma treatment (including chemotherapy, radiotherapy, radioimmunotherapy or immunotherapy). The time to the next anti-lymphoma treatment was of special interest to the study.
- 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 date of first documented administration of a new anti-lymphoma treatment (Average of 55.71 months and a maximum up to 95.2 months)
- title
- Kaplan Meier Estimate of Time to Next Anti-Lymphoma Treatment (TTNLT)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice