TriangleNCT00422383 · OUTCOME
Maximum Observed Serum Concentrations Following the 2nd Infusion of Rituximab (Csecond) in the 1st and 2nd Courses of Treatment in µg/mL
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- µg/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Days 1 and 15 (before infusion and 30 minutes following infusion) and Weeks 4, 8, 16, 24, 26, 28, 32, 40, and 48 or early withdrawal and at Weeks 24 and 48 of safety follow-up (1 year period following the completion of study treatment).
What was measured
Csecond values were estimated from rituximab serum concentrations by non-compartmental methods using the software WinNonlin Enterprise Version 5.2.
Analysis population: ITT-M2 population, n = number of participants assessed for the given parameter at the specified timepoint.
Groups in this outcome
Rituximab Low Dose + Methotrexate
Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
Rituximab Escalated Dose + Methotrexate
Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
Rituximab High Dose + Methotrexate
Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
| Group | Source count |
|---|---|
| Rituximab Low Dose + Methotrexate | 130 |
| Rituximab Escalated Dose + Methotrexate | 116 |
| Rituximab High Dose + Methotrexate | 90 |
Reported measurements
First course (n=130,116,90)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab Low Dose + Methotrexate | 194 | 65 | Not reported | Not reported | Not reported |
| Rituximab Escalated Dose + Methotrexate | 190 | 57 | Not reported | Not reported | Not reported |
| Rituximab High Dose + Methotrexate | 373 | 116 | Not reported | Not reported | Not reported |
Second course (n=121,107,88)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Rituximab Low Dose + Methotrexate | 209 | 70 | Not reported | Not reported | Not reported |
| Rituximab Escalated Dose + Methotrexate | 380 | 139 | Not reported | Not reported | Not reported |
| Rituximab High Dose + Methotrexate | 392 | 123 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 65
- value
- 194
- group Id
- OG001
- spread
- 57
- value
- 190
- group Id
- OG002
- spread
- 116
- value
- 373
- title
- First course (n=130,116,90)
- categories
- measurements
- group Id
- OG000
- spread
- 70
- value
- 209
- group Id
- OG001
- spread
- 139
- value
- 380
- group Id
- OG002
- spread
- 123
- value
- 392
- title
- Second course (n=121,107,88)
- denoms
- counts
- group Id
- OG000
- value
- 130
- group Id
- OG001
- value
- 116
- group Id
- OG002
- value
- 90
- units
- Participants
- description
- Csecond values were estimated from rituximab serum concentrations by non-compartmental methods using the software WinNonlin Enterprise Version 5.2.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
- id
- OG000
- title
- Rituximab Low Dose + Methotrexate
- description
- Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
- id
- OG001
- title
- Rituximab Escalated Dose + Methotrexate
- description
- Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
- id
- OG002
- title
- Rituximab High Dose + Methotrexate
- param Type
- MEAN
- population Description
- ITT-M2 population, n = number of participants assessed for the given parameter at the specified timepoint.
- reporting Status
- POSTED
- time Frame
- Days 1 and 15 (before infusion and 30 minutes following infusion) and Weeks 4, 8, 16, 24, 26, 28, 32, 40, and 48 or early withdrawal and at Weeks 24 and 48 of safety follow-up (1 year period following the completion of study treatment).
- title
- Maximum Observed Serum Concentrations Following the 2nd Infusion of Rituximab (Csecond) in the 1st and 2nd Courses of Treatment in µg/mL
- type
- SECONDARY
- unit Of Measure
- µg/mL
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Preserved source evidence · Not medical advice