TriangleNCT01200758 · OUTCOME
Stage II: Percentage of Participants With Complete Response at the End of Induction 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 II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
What was measured
Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu 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: Stage II ITT Population.
Groups in this outcome
Stage 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 entered rituximab IV maintenance therapy (375 mg/m\^2) once every 8 weeks for 24 months.
Stage II: Rituximab SC + Chemotherapy (CHOP/CVP)
First cycle of rituximab IV infusion (375 mg/m\^2) + 7 cycles of rituximab SC (1400 mg; 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 entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
| Group | Source count |
|---|---|
| Stage II: Rituximab IV + Chemotherapy (CHOP/CVP) | 141 |
| Stage II: Rituximab SC + Chemotherapy (CHOP/CVP) | 142 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stage II: Rituximab IV + Chemotherapy (CHOP/CVP) | 34.8 | Not reported | 26.9 | 43.2 | Not reported |
| Stage II: Rituximab SC + Chemotherapy (CHOP/CVP) | 28.2 | Not reported | 20.9 | 36.3 | Not reported |
Source statistical analyses
- ci Lower Limit
- -17.8
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.6
- 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
- 0.2331
- param Type
- Difference in response rates
- param Value
- -6.58
- statistical Method
- Chi-squared
- ci Lower Limit
- 0.44
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.22
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- param Type
- Odds Ratio (OR)
- param Value
- 0.74
Complete source fields
- analyses
- ci Lower Limit
- -17.8
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.6
- 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
- 0.2331
- param Type
- Difference in response rates
- param Value
- -6.58
- statistical Method
- Chi-squared
- ci Lower Limit
- 0.44
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.22
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- param Type
- Odds Ratio (OR)
- param Value
- 0.74
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 26.9
- upper Limit
- 43.2
- value
- 34.8
- group Id
- OG001
- lower Limit
- 20.9
- upper Limit
- 36.3
- value
- 28.2
- denoms
- counts
- group Id
- OG000
- value
- 141
- group Id
- OG001
- value
- 142
- units
- Participants
- description
- Complete Response comprised of CR and CRu. A participant was defined as a responder if they sustained a CR or CRu 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 entered rituximab IV maintenance therapy (375 mg/m\^2) once every 8 weeks for 24 months.
- id
- OG000
- title
- Stage II: Rituximab IV + Chemotherapy (CHOP/CVP)
- description
- First cycle of rituximab IV infusion (375 mg/m\^2) + 7 cycles of rituximab SC (1400 mg; 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 entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
- id
- OG001
- title
- Stage II: Rituximab SC + Chemotherapy (CHOP/CVP)
- param Type
- NUMBER
- population Description
- Stage II ITT Population.
- reporting Status
- POSTED
- time Frame
- Stage II: Baseline up to end of induction treatment Cy8 (24 weeks) (1 Cy=3 weeks)
- title
- Stage II: Percentage of Participants With Complete Response at the End of Induction 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