TriangleNCT01200758 · OUTCOME
Stage I and II (Pooled): Event-Free Survival Assessed Using International Working Group Response Criteria for NHL
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
- Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description)
What was measured
Event-free survival was defined as the time from randomization to disease progression/relapse, death or initiation of new NHL therapy. If the specified event (progression/relapse, death or new anti-lymphoma treatment) did not occur, event-free survival was censored at the last tumor assessment date either during treatment or follow up. Event-free survival analysis was performed using Kaplan-Meier curves. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 \& 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to a median of 27 months; up to data cutoff of 31 Oct 2017 \[up to 6 years\])
Analysis population: ITT population.
Groups in this outcome
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)
Eight cycles of rituximab IV infusion (375 mg/m\^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m\^2) once every 8 weeks for 24 months.
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)
First cycle rituximab IV infusion (375 mg/m\^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
| Group | Source count |
|---|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 205 |
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 205 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | NA | Not reported | 2126 | NA | Data for upper limit of 95% CI was not reached due to low number (\<50%) of participants with event of interest. |
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | NA | Not reported | NA | NA | Data for median and upper limit of 95% CI were not reached due to low number (\<50%) of participants with event of interest. |
Source statistical analyses
- ci Lower Limit
- 0.71
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.36
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.9115
- param Type
- Hazard Ratio (HR)
- param Value
- 0.98
- statistical Method
- Wald test
Complete source fields
- analyses
- ci Lower Limit
- 0.71
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.36
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.9115
- param Type
- Hazard Ratio (HR)
- param Value
- 0.98
- statistical Method
- Wald test
- classes
- categories
- measurements
- comment
- Data for upper limit of 95% CI was not reached due to low number (\<50%) of participants with event of interest.
- group Id
- OG000
- lower Limit
- 2126
- upper Limit
- NA
- value
- NA
- comment
- Data for median and upper limit of 95% CI were not reached due to low number (\<50%) of participants with event of interest.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 205
- group Id
- OG001
- value
- 205
- units
- Participants
- description
- Event-free survival was defined as the time from randomization to disease progression/relapse, death or initiation of new NHL therapy. If the specified event (progression/relapse, death or new anti-lymphoma treatment) did not occur, event-free survival was censored at the last tumor assessment date either during treatment or follow up. Event-free survival analysis was performed using Kaplan-Meier curves. Baseline, D1 of all cycles (Cy 1-20) (1 Cy=3 weeks for Cy1-8 \& 8 weeks for Cy9-20), at early withdrawal, at follow-up, every 12 weeks for 96 weeks or until documented disease progression/relapse or death (up to a median of 27 months; up to data cutoff of 31 Oct 2017 \[up to 6 years\])
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Eight cycles of rituximab IV infusion (375 mg/m\^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m\^2) once every 8 weeks for 24 months.
- id
- OG000
- title
- Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)
- description
- First cycle rituximab IV infusion (375 mg/m\^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
- id
- OG001
- title
- Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)
- param Type
- MEDIAN
- population Description
- ITT population.
- reporting Status
- POSTED
- time Frame
- Baseline up to disease progression or death up to data cutoff of 31 Oct 2017 (up to 6 years) (See detailed timeframe in Outcome Measure description)
- title
- Stage I and II (Pooled): Event-Free Survival Assessed Using International Working Group Response Criteria for NHL
- type
- SECONDARY
- unit Of Measure
- days
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Preserved source evidence · Not medical advice