TriangleNCT00090051 · OUTCOME
Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Mean observation time at time of analysis was approximately 26 months
What was measured
Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause, whichever came first. Patients without a PFS event were censored at their last tumor assessment date.
Analysis population: Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.
Groups in this outcome
Fludarabine+Cyclophosphamide (FC)
Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
Fludarabine+Cyclophosphamide+Rituximab (FCR)
Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
| Group | Source count |
|---|---|
| Fludarabine+Cyclophosphamide (FC) | 276 |
| Fludarabine+Cyclophosphamide+Rituximab (FCR) | 276 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Fludarabine+Cyclophosphamide (FC) | 660 | Not reported | 556 | 735 | Not reported |
| Fludarabine+Cyclophosphamide+Rituximab (FCR) | 813 | Not reported | 670 | 947 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.60
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.96
- estimate Comment
- The hazard ratio was estimated using Cox regression. The hazard ratio is relative to the fludarabine+cyclophosphamide(FC) group.
- group Description
- The null hypothesis was that there was no difference between the 2 treatment groups. The alternative hypothesis was that progression-free survival was longer in the fludarabine+cyclophosphamide+rituximab (FCR) group.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0218
- param Type
- Hazard Ratio (HR)
- param Value
- 0.76
- statistical Comment
- non-stratified
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.60
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.96
- estimate Comment
- The hazard ratio was estimated using Cox regression. The hazard ratio is relative to the fludarabine+cyclophosphamide(FC) group.
- group Description
- The null hypothesis was that there was no difference between the 2 treatment groups. The alternative hypothesis was that progression-free survival was longer in the fludarabine+cyclophosphamide+rituximab (FCR) group.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0218
- param Type
- Hazard Ratio (HR)
- param Value
- 0.76
- statistical Comment
- non-stratified
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 556
- upper Limit
- 735
- value
- 660
- group Id
- OG001
- lower Limit
- 670
- upper Limit
- 947
- value
- 813
- denoms
- counts
- group Id
- OG000
- value
- 276
- group Id
- OG001
- value
- 276
- units
- Participants
- description
- Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause, whichever came first. Patients without a PFS event were censored at their last tumor assessment date.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
- id
- OG000
- title
- Fludarabine+Cyclophosphamide (FC)
- description
- Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
- id
- OG001
- title
- Fludarabine+Cyclophosphamide+Rituximab (FCR)
- param Type
- MEDIAN
- population Description
- Intent-to-treat (ITT) population was comprised of all patients randomized in the study, irrespective of whether they received treatment or not.
- reporting Status
- POSTED
- time Frame
- Mean observation time at time of analysis was approximately 26 months
- title
- Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)
- type
- PRIMARY
- unit Of Measure
- Days
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Preserved source evidence · Not medical advice