TriangleNCT01200758 · OUTCOME
Stage I: Observed Area Under the Serum Concentration-Time Curve (AUC) of Rituximab
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- mcg*day/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Stage I (Induction): Predose (within 2 hour [hr]) up to data cutoff of 11 Apr 2012 [up to 26 months]) (See detailed timeframe in Outcome Measure description)
What was measured
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Predose (within 2 hr) and 24 hrs postdose on Cy 7 (D1,3,7,15), predose (0 hr) on Cy 8 D1 (1 Cy=3 weeks); additionally within 15 minutes after end of infusion (infusion duration=30 minutes) on Cy 7 D1 for rituximab IV (up to data cutoff of 11 Apr 2012 \[up to 26 months\])
Analysis population: Stage I PK evaluable population. Here, number of participants analyzed = participants evaluable for this outcome measure.
Groups in this outcome
Stage I: 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: Rituximab SC + Chemotherapy (CHOP/CVP)
First cycle of rituximab IV (375 mg/m\^2) + 7 cycles of rituximab subcutaneously (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 during induction, entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
| Group | Source count |
|---|---|
| Stage I: Rituximab IV + Chemotherapy (CHOP/CVP) | 58 |
| Stage I: Rituximab SC + Chemotherapy (CHOP/CVP) | 55 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Stage I: Rituximab IV + Chemotherapy (CHOP/CVP) | 2734.21 | 32.51 | Not reported | Not reported | Not reported |
| Stage I: Rituximab SC + Chemotherapy (CHOP/CVP) | 3778.93 | 37.59 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 1.24
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 1.53
- group Description
- The ratio of observed rituximab serum was determined as AUC SC/AUC IV during Cycle 7 of induction treatment.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- param Type
- Geometric mean ratio
- param Value
- 1.38
Complete source fields
- analyses
- ci Lower Limit
- 1.24
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 1.53
- group Description
- The ratio of observed rituximab serum was determined as AUC SC/AUC IV during Cycle 7 of induction treatment.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- param Type
- Geometric mean ratio
- param Value
- 1.38
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 32.51
- value
- 2734.21
- group Id
- OG001
- spread
- 37.59
- value
- 3778.93
- denoms
- counts
- group Id
- OG000
- value
- 58
- group Id
- OG001
- value
- 55
- units
- Participants
- description
- AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. Predose (within 2 hr) and 24 hrs postdose on Cy 7 (D1,3,7,15), predose (0 hr) on Cy 8 D1 (1 Cy=3 weeks); additionally within 15 minutes after end of infusion (infusion duration=30 minutes) on Cy 7 D1 for rituximab IV (up to data cutoff of 11 Apr 2012 \[up to 26 months\])
- dispersion Type
- Geometric Coefficient of Variation
- 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: Rituximab IV + Chemotherapy (CHOP/CVP)
- description
- First cycle of rituximab IV (375 mg/m\^2) + 7 cycles of rituximab subcutaneously (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 during induction, entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
- id
- OG001
- title
- Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)
- param Type
- GEOMETRIC_MEAN
- population Description
- Stage I PK evaluable population. Here, number of participants analyzed = participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Stage I (Induction): Predose (within 2 hour [hr]) up to data cutoff of 11 Apr 2012 [up to 26 months]) (See detailed timeframe in Outcome Measure description)
- title
- Stage I: Observed Area Under the Serum Concentration-Time Curve (AUC) of Rituximab
- type
- SECONDARY
- unit Of Measure
- mcg*day/mL
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Preserved source evidence · Not medical advice