NCT01200758 · OUTCOME
Stage I and II (Pooled): Ctrough of Rituximab at Each Induction Treatment Cycle
A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabThera) Intravenous in Participannts With Follicular Non-Hodgkin's Lymphoma · Source last updated 2018-11-27
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- mcg/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Stage I and II (Pooled): Predose (within 2hr) up to data cutoff of 31 Oct 2013 [up to 32 months]) (See detailed timeframe in Outcome Measure description)
What was measured
Stage I and II (Induction): Rituximab IV: Predose (within 2 hr) on D1 of Cy1-8 (1 Cy=3 weeks \& 4 weeks for Cy8); Rituximab SC: Predose (within 2 hr) on D1 of Cy1 \& Cy3-8 (1 Cy=3 weeks and 4 weeks for Cy8), predose (within 2 hr) on D0 of Cy2 (up to data cutoff of 31 Oct 2013 \[up to 32 months\])
Analysis population: ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here "n" = number of participants evaluable for this outcome measure at specified timepoint.
Groups in this outcome
Stage I and 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 during induction, entered rituximab IV maintenance therapy (375 mg/m\^2) once every 8 weeks for 24 months.
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)
First cycle rituximab IV infusion (375 mg/m\^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 198 |
|---|
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 193 |
|---|
Reported measurements
Cycle 1 (n = 198, 193)
Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 14.00 | 157.53 | Not reported | Not reported | Not reported |
|---|
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 12.88 | 189.70 | Not reported | Not reported | Not reported |
|---|
Cycle 2 (n = 197, 190)
Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 30.13 | 145.36 | Not reported | Not reported | Not reported |
|---|
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 40.00 | 124.50 | Not reported | Not reported | Not reported |
|---|
Cycle 3 (n = 192, 190)
Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 45.25 | 110.35 | Not reported | Not reported | Not reported |
|---|
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 63.83 | 101.83 | Not reported | Not reported | Not reported |
|---|
Cycle 4 (n = 186, 185)
Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 54.06 | 108.90 | Not reported | Not reported | Not reported |
|---|
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 81.71 | 92.28 | Not reported | Not reported | Not reported |
|---|
Cycle 5 (n = 185, 185)
Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 64.68 | 89.90 | Not reported | Not reported | Not reported |
|---|
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 98.00 | 71.91 | Not reported | Not reported | Not reported |
|---|
Cycle 6 (n = 187, 180)
Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 71.02 | 87.60 | Not reported | Not reported | Not reported |
|---|
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 109.56 | 58.74 | Not reported | Not reported | Not reported |
|---|
Cycle 7 (n = 183, 172)
Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 78.31 | 77.76 | Not reported | Not reported | Not reported |
|---|
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 120.75 | 55.60 | Not reported | Not reported | Not reported |
|---|
Cycle 8 (n = 52, 54)
Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP) | 77.60 | 70.53 | Not reported | Not reported | Not reported |
|---|
| Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP) | 131.48 | 50.20 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 157.53
- value
- 14.00
- group Id
- OG001
- spread
- 189.70
- value
- 12.88
- title
- Cycle 1 (n = 198, 193)
- categories
- measurements
- group Id
- OG000
- spread
- 145.36
- value
- 30.13
- group Id
- OG001
- spread
- 124.50
- value
- 40.00
- title
- Cycle 2 (n = 197, 190)
- categories
- measurements
- group Id
- OG000
- spread
- 110.35
- value
- 45.25
- group Id
- OG001
- spread
- 101.83
- value
- 63.83
- title
- Cycle 3 (n = 192, 190)
- categories
- measurements
- group Id
- OG000
- spread
- 108.90
- value
- 54.06
- group Id
- OG001
- spread
- 92.28
- value
- 81.71
- title
- Cycle 4 (n = 186, 185)
- categories
- measurements
- group Id
- OG000
- spread
- 89.90
- value
- 64.68
- group Id
- OG001
- spread
- 71.91
- value
- 98.00
- title
- Cycle 5 (n = 185, 185)
- categories
- measurements
- group Id
- OG000
- spread
- 87.60
- value
- 71.02
- group Id
- OG001
- spread
- 58.74
- value
- 109.56
- title
- Cycle 6 (n = 187, 180)
- categories
- measurements
- group Id
- OG000
- spread
- 77.76
- value
- 78.31
- group Id
- OG001
- spread
- 55.60
- value
- 120.75
- title
- Cycle 7 (n = 183, 172)
- categories
- measurements
- group Id
- OG000
- spread
- 70.53
- value
- 77.60
- group Id
- OG001
- spread
- 50.20
- value
- 131.48
- title
- Cycle 8 (n = 52, 54)
- denoms
- counts
- group Id
- OG000
- value
- 198
- group Id
- OG001
- value
- 193
- units
- Participants
- description
- Stage I and II (Induction): Rituximab IV: Predose (within 2 hr) on D1 of Cy1-8 (1 Cy=3 weeks \& 4 weeks for Cy8); Rituximab SC: Predose (within 2 hr) on D1 of Cy1 \& Cy3-8 (1 Cy=3 weeks and 4 weeks for Cy8), predose (within 2 hr) on D0 of Cy2 (up to data cutoff of 31 Oct 2013 \[up to 32 months\])
- 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 and II: Rituximab IV + Chemotherapy (CHOP/CVP)
- description
- First cycle rituximab IV infusion (375 mg/m\^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy 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 I and II: Rituximab SC + Chemotherapy (CHOP/CVP)
- param Type
- GEOMETRIC_MEAN
- population Description
- ITT Population. Here, number of participants analyzed = participants evaluable for the outcome measure. Here "n" = number of participants evaluable for this outcome measure at specified timepoint.
- reporting Status
- POSTED
- time Frame
- Stage I and II (Pooled): Predose (within 2hr) up to data cutoff of 31 Oct 2013 [up to 32 months]) (See detailed timeframe in Outcome Measure description)
- title
- Stage I and II (Pooled): Ctrough of Rituximab at Each Induction Treatment Cycle
- type
- SECONDARY
- unit Of Measure
- mcg/mL
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Preserved source evidence · Not medical advice
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