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NCT01200758 · OUTCOME

Stage I and II (Pooled): Ctrough of Rituximab at Each Maintenance 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 (maintenance): Predose (within 2hr) up to data cutoff of 11 Jan 2016 [up to 6 years]) (See detailed timeframe in Outcome Measure description)

What was measured

Stage I and II (maintenance): D29 of Cy8 (induction; 1 Cy=4 weeks), predose (within 2 hr) on D1 of Cy9 to 19 (maintenance Cy1 to 12 \[1 Cy=8 weeks\]; up to data cutoff of 11 Jan 2016 \[up to 6 years\])

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

GroupSource count
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)174
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)170

Reported measurements

Cycle 8 (n = 174, 170)
Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)37.6994.30Not reportedNot reportedNot reported
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)61.3165.52Not reportedNot reportedNot reported
Cycle 9 (n = 171, 168)
Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)30.3575.03Not reportedNot reportedNot reported
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)49.4781.23Not reportedNot reportedNot reported
Cycle 10 (n = 164, 160)
Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)28.4484.64Not reportedNot reportedNot reported
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)47.2773.03Not reportedNot reportedNot reported
Cycle 11 (n = 164, 157)
Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)28.7765.28Not reportedNot reportedNot reported
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)46.7066.80Not reportedNot reportedNot reported
Cycle 12 (n = 160, 150)
Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)28.8056.97Not reportedNot reportedNot reported
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)44.7268.74Not reportedNot reportedNot reported
Cycle 13 (n = 157, 150)
Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)28.8454.04Not reportedNot reportedNot reported
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)44.3267.67Not reportedNot reportedNot reported
Cycle 14 (n = 153, 147)
Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)28.0955.61Not reportedNot reportedNot reported
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)43.3267.97Not reportedNot reportedNot reported
Cycle 15 (n = 148, 143)
Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)28.1952.69Not reportedNot reportedNot reported
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)44.1167.92Not reportedNot reportedNot reported
Cycle 16 (n = 150, 145)
Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)28.0557.19Not reportedNot reportedNot reported
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)42.9664.32Not reportedNot reportedNot reported
Cycle 17 (n = 149, 143)
Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)28.2457.51Not reportedNot reportedNot reported
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)42.8265.67Not reportedNot reportedNot reported
Cycle 18 (n = 143, 132)
Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)28.5962.06Not reportedNot reportedNot reported
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)44.7968.56Not reportedNot reportedNot reported
Cycle 19 (n = 138, 131)
Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)27.7578.26Not reportedNot reportedNot reported
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)43.6969.02Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        94.30
        value
        37.69
      2. group Id
        OG001
        spread
        65.52
        value
        61.31
    title
    Cycle 8 (n = 174, 170)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        75.03
        value
        30.35
      2. group Id
        OG001
        spread
        81.23
        value
        49.47
    title
    Cycle 9 (n = 171, 168)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        84.64
        value
        28.44
      2. group Id
        OG001
        spread
        73.03
        value
        47.27
    title
    Cycle 10 (n = 164, 160)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        65.28
        value
        28.77
      2. group Id
        OG001
        spread
        66.80
        value
        46.70
    title
    Cycle 11 (n = 164, 157)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        56.97
        value
        28.80
      2. group Id
        OG001
        spread
        68.74
        value
        44.72
    title
    Cycle 12 (n = 160, 150)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        54.04
        value
        28.84
      2. group Id
        OG001
        spread
        67.67
        value
        44.32
    title
    Cycle 13 (n = 157, 150)
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        55.61
        value
        28.09
      2. group Id
        OG001
        spread
        67.97
        value
        43.32
    title
    Cycle 14 (n = 153, 147)
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        52.69
        value
        28.19
      2. group Id
        OG001
        spread
        67.92
        value
        44.11
    title
    Cycle 15 (n = 148, 143)
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        57.19
        value
        28.05
      2. group Id
        OG001
        spread
        64.32
        value
        42.96
    title
    Cycle 16 (n = 150, 145)
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        57.51
        value
        28.24
      2. group Id
        OG001
        spread
        65.67
        value
        42.82
    title
    Cycle 17 (n = 149, 143)
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        62.06
        value
        28.59
      2. group Id
        OG001
        spread
        68.56
        value
        44.79
    title
    Cycle 18 (n = 143, 132)
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        78.26
        value
        27.75
      2. group Id
        OG001
        spread
        69.02
        value
        43.69
    title
    Cycle 19 (n = 138, 131)
denoms
  1. counts
    1. group Id
      OG000
      value
      174
    2. group Id
      OG001
      value
      170
    units
    Participants
description
Stage I and II (maintenance): D29 of Cy8 (induction; 1 Cy=4 weeks), predose (within 2 hr) on D1 of Cy9 to 19 (maintenance Cy1 to 12 \[1 Cy=8 weeks\]; up to data cutoff of 11 Jan 2016 \[up to 6 years\])
dispersion Type
Geometric Coefficient of Variation
groups
  1. 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)
  2. 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 (maintenance): Predose (within 2hr) up to data cutoff of 11 Jan 2016 [up to 6 years]) (See detailed timeframe in Outcome Measure description)
title
Stage I and II (Pooled): Ctrough of Rituximab at Each Maintenance Treatment Cycle
type
SECONDARY
unit Of Measure
mcg/mL

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Preserved source evidence · Not medical advice