TriangleNCT01292603 · OUTCOME
Part 2: Observed Area Under the Serum Concentration-Curve (AUC) of Rituximab at Cycle 6
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- μg*day/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6
What was measured
AUC values were calculated by numerical integration using the linear trapezoidal rule. AUC levels were analyzed using the model below: Ln(AUC) = μ + τi + BlTLij + εij wherein, Ln is the natural log, μ denotes the overall mean effect, τi the effect in each treatment group, BlTLij the tumor load at baseline for each patient and εij a random error variable with normal distribution and mean 0. The treatment effect therein was based on a contrast statement in the model to calculate 90 % confidence intervals for ln(AUC SC)- ln(AUC IV).
Analysis population: Only participants who entered Part 2 of the study and had PK data available were included in the analysis.
Groups in this outcome
Part 2 : Rituximab IV 500 mg/m^2
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
Part 2: Rituximab SC 1600 mg
Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
| Group | Source count |
|---|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 58 |
| Part 2: Rituximab SC 1600 mg | 51 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 3630.43 | 38.61 | Not reported | Not reported | Not reported |
| Part 2: Rituximab SC 1600 mg | 4088.78 | 37.52 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.979
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 1.242
- estimate Comment
- Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- param Type
- Adjusted geometric mean ratio
- param Value
- 1.102
Complete source fields
- analyses
- ci Lower Limit
- 0.979
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 1.242
- estimate Comment
- Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- param Type
- Adjusted geometric mean ratio
- param Value
- 1.102
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 38.61
- value
- 3630.43
- group Id
- OG001
- spread
- 37.52
- value
- 4088.78
- denoms
- counts
- group Id
- OG000
- value
- 58
- group Id
- OG001
- value
- 51
- units
- Participants
- description
- AUC values were calculated by numerical integration using the linear trapezoidal rule. AUC levels were analyzed using the model below: Ln(AUC) = μ + τi + BlTLij + εij wherein, Ln is the natural log, μ denotes the overall mean effect, τi the effect in each treatment group, BlTLij the tumor load at baseline for each patient and εij a random error variable with normal distribution and mean 0. The treatment effect therein was based on a contrast statement in the model to calculate 90 % confidence intervals for ln(AUC SC)- ln(AUC IV).
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: IV rituximab 500 mg/m\^2 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
- id
- OG000
- title
- Part 2 : Rituximab IV 500 mg/m^2
- description
- Participants received the following in 28-day cycles. Cycle 1: IV rituximab 375 mg/m\^2 on Day 0 Cycles 2-6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m\^2 on Days 1-3 (or as an oral dose of 24 mg/m\^2 on Days 1-5 or 30-40 mg/m\^2 on Days 1-3), and IV cyclophosphamide 250 mg/m\^2 on Days 1-3 (or as an oral dose of 150 mg/m\^2 on Days 1-5 or 200-250 mg/m\^2 on Days 1-3).
- id
- OG001
- title
- Part 2: Rituximab SC 1600 mg
- param Type
- GEOMETRIC_MEAN
- population Description
- Only participants who entered Part 2 of the study and had PK data available were included in the analysis.
- reporting Status
- POSTED
- time Frame
- Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6
- title
- Part 2: Observed Area Under the Serum Concentration-Curve (AUC) of Rituximab at Cycle 6
- type
- SECONDARY
- unit Of Measure
- μg*day/mL
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Preserved source evidence · Not medical advice