TriangleNCT00722137 · OUTCOME
Time to Progression (TTP)
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
- Median duration of follow-up of 40 months
What was measured
Time to progression was defined as the duration from the date of randomization until the date of first documented evidence of progressive disease (PD) or date of relapse for subjects who experienced complete response (CR) or complete response, unconfirmed (CRu). PD and response were based on the assessment of an Independent Review Committee.
Analysis population: The population consisted of all randomized participants.
Groups in this outcome
R-CHOP
Rituximab 375 mg/m\^2, Cyclophosphamide 750 mg/m\^2, Doxorubicin 50 mg/m\^2, Vincristine 1.4 mg/m\^2 and Prednisone 100 mg/m\^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles Vincristine: Vincristine intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
VcR-CAP
Rituximab 375 mg/m\^2, Cyclophosphamide 750 mg/m\^2, Doxorubicin 50 mg/m\^2, VELCADE 1.3 mg/m\^2, and Prednisone 100 mg/m\^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles.
| Group | Source count |
|---|---|
| R-CHOP | 244 |
| VcR-CAP | 243 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| R-CHOP | 490.0 | Not reported | 417.0 | 550.0 | Not reported |
| VcR-CAP | 929.0 | Not reported | 696.0 | 1245.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.45
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.74
- estimate Comment
- Hazards ratio estimate is based on a Cox´s model stratified by IPI risk and stage of disease. A hazard ratio \< 1 indicates an advantage for VcR-CAP.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.58
- statistical Comment
- Based on Log rank test stratified with IPI risk and stage of disease.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.45
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.74
- estimate Comment
- Hazards ratio estimate is based on a Cox´s model stratified by IPI risk and stage of disease. A hazard ratio \< 1 indicates an advantage for VcR-CAP.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.58
- statistical Comment
- Based on Log rank test stratified with IPI risk and stage of disease.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 417.0
- upper Limit
- 550.0
- value
- 490.0
- group Id
- OG001
- lower Limit
- 696.0
- upper Limit
- 1245.0
- value
- 929.0
- denoms
- counts
- group Id
- OG000
- value
- 244
- group Id
- OG001
- value
- 243
- units
- Participants
- description
- Time to progression was defined as the duration from the date of randomization until the date of first documented evidence of progressive disease (PD) or date of relapse for subjects who experienced complete response (CR) or complete response, unconfirmed (CRu). PD and response were based on the assessment of an Independent Review Committee.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Rituximab 375 mg/m\^2, Cyclophosphamide 750 mg/m\^2, Doxorubicin 50 mg/m\^2, Vincristine 1.4 mg/m\^2 and Prednisone 100 mg/m\^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles Vincristine: Vincristine intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles.
- id
- OG000
- title
- R-CHOP
- description
- Rituximab 375 mg/m\^2, Cyclophosphamide 750 mg/m\^2, Doxorubicin 50 mg/m\^2, VELCADE 1.3 mg/m\^2, and Prednisone 100 mg/m\^2 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles.
- id
- OG001
- title
- VcR-CAP
- param Type
- MEDIAN
- population Description
- The population consisted of all randomized participants.
- reporting Status
- POSTED
- time Frame
- Median duration of follow-up of 40 months
- title
- Time to Progression (TTP)
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice