TriangleNCT01200758 · OUTCOME
Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Maintenance Treatment 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
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Stage I and II: Baseline up to 57 days after last maintenance dose (last maintenance dose: maintenance Cy12/Study Cy20 [30 months]) (up to data cutoff of 31 Oct 2017 [up to 6 years]) (1 Cy=8 weeks)
What was measured
Overall Response comprised of CR, CRu, or PR . A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by \>75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.
Analysis population: ITT population; only participants who entered the maintenance phase and received at least 1 cycle of rituximab maintenance treatment from Cycle 9 to Cycle 20 were included in the analysis.
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) | 178 |
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 172 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 78.1 | Not reported | 71.3 | 83.9 | Not reported |
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 77.9 | Not reported | 71.0 | 83.9 | Not reported |
Source statistical analyses
- ci Lower Limit
- -9.2
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 8.8
- estimate Comment
- The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.9671
- param Type
- Difference in response rates
- param Value
- -0.18
- statistical Method
- Chi-squared
- ci Lower Limit
- 0.60
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.64
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- param Type
- Odds Ratio (OR)
- param Value
- 0.99
Complete source fields
- analyses
- ci Lower Limit
- -9.2
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 8.8
- estimate Comment
- The 95% CI for the difference in response rates was estimated using the Hauck-Anderson method.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.9671
- param Type
- Difference in response rates
- param Value
- -0.18
- statistical Method
- Chi-squared
- ci Lower Limit
- 0.60
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.64
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- param Type
- Odds Ratio (OR)
- param Value
- 0.99
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 71.3
- upper Limit
- 83.9
- value
- 78.1
- group Id
- OG001
- lower Limit
- 71.0
- upper Limit
- 83.9
- value
- 77.9
- denoms
- counts
- group Id
- OG000
- value
- 178
- group Id
- OG001
- value
- 172
- units
- Participants
- description
- Overall Response comprised of CR, CRu, or PR . A participant was defined as a responder if they sustained a CR, CRu or PR at the end of induction treatment. Response assessment was based on clinical examination and CT scans. Assessment of tumor response was performed according to the International Working Group response criteria for NHL. CR: complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy; CRu: CR along with regression in lymph node mass by \>75% in SPD. The 95% CI for the response rates was estimated for one sample binomial using Pearson-Clopper.
- 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
- NUMBER
- population Description
- ITT population; only participants who entered the maintenance phase and received at least 1 cycle of rituximab maintenance treatment from Cycle 9 to Cycle 20 were included in the analysis.
- reporting Status
- POSTED
- time Frame
- Stage I and II: Baseline up to 57 days after last maintenance dose (last maintenance dose: maintenance Cy12/Study Cy20 [30 months]) (up to data cutoff of 31 Oct 2017 [up to 6 years]) (1 Cy=8 weeks)
- title
- Stage I and II (Pooled): Percentage of Participants With Overall Response at the End of Maintenance Treatment Assessed Using International Working Group Response Criteria for NHL
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice