TriangleNCT01292603 · OUTCOME
Part 2: Rituximab C Trough Levels at Cycle 5
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- μg/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- +/- 25hours around the 28th day post the 5th Cycle of Rituximab administration
What was measured
Ctrough is defined as the trough or minimum serum concentration in a given cycle of treatment. The objective of Part 2 was to demonstrate the comparability of the observed Ctrough of rituximab SC 1600 mg and rituximab IV 500 mg/m2 at Cycle 5, as assessed by a non-inferiority test with a lower boundary of at least 0.8 for the 90% CI.
Analysis population: Only participants who entered Part 2 of the study and had pharmacokinetic (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 | 69 |
| Part 2: Rituximab SC 1600 mg | 65 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 : Rituximab IV 500 mg/m^2 | 61.50 | 89.54 | Not reported | Not reported | Not reported |
| Part 2: Rituximab SC 1600 mg | 97.53 | 55.27 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.269
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 1.852
- estimate Comment
- Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- A standard non-inferiority margin of 0.8 for the ratio of Ctrough was used. The non-inferiority limit corresponds to a maximal 20 percent (%) loss in Ctrough which is considered acceptable given the high variability and range of Ctrough data, with an 80% power and a one-sided alpha of 0.05.
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- param Type
- Adjusted geometric mean ratio
- param Value
- 1.533
Complete source fields
- analyses
- ci Lower Limit
- 1.269
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 1.852
- estimate Comment
- Ratio based on geometric scale and adjusted for the covariate tumor load at baseline.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- A standard non-inferiority margin of 0.8 for the ratio of Ctrough was used. The non-inferiority limit corresponds to a maximal 20 percent (%) loss in Ctrough which is considered acceptable given the high variability and range of Ctrough data, with an 80% power and a one-sided alpha of 0.05.
- non Inferiority Type
- NON_INFERIORITY_OR_EQUIVALENCE
- param Type
- Adjusted geometric mean ratio
- param Value
- 1.533
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 89.54
- value
- 61.50
- group Id
- OG001
- spread
- 55.27
- value
- 97.53
- denoms
- counts
- group Id
- OG000
- value
- 69
- group Id
- OG001
- value
- 65
- units
- Participants
- description
- Ctrough is defined as the trough or minimum serum concentration in a given cycle of treatment. The objective of Part 2 was to demonstrate the comparability of the observed Ctrough of rituximab SC 1600 mg and rituximab IV 500 mg/m2 at Cycle 5, as assessed by a non-inferiority test with a lower boundary of at least 0.8 for the 90% CI.
- 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 pharmacokinetic (PK) data available were included in the analysis.
- reporting Status
- POSTED
- time Frame
- +/- 25hours around the 28th day post the 5th Cycle of Rituximab administration
- title
- Part 2: Rituximab C Trough Levels at Cycle 5
- type
- PRIMARY
- unit Of Measure
- μg/mL
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Preserved source evidence · Not medical advice