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NCT01200758 · OUTCOME

Stage I and II (Pooled): Rituximab Levels 12 Weeks, 24 Weeks, and 36 Weeks After the Last Rituximab Administration

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
MEDIAN
Unit
mcg/mL
Interval / dispersion
Full Range
Time frame
12 weeks, 24 weeks, and 36 weeks after the last rituximab administration (up to data cutoff of 11 Jan 2016 [up to 6 years])

Analysis population: Safety Analysis Population included all participants who received at least one dose of rituximab, either IV or SC. Participants were analyzed as treated. 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)117
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)118

Reported measurements

Week 12: Follow-up Visit 1 (n = 117, 118)
Values in mcg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)15.60Not reported0.7080.40Not reported
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)22.35Not reported0.65107.00Not reported
Week 24: Follow-up Visit 2 (n = 88, 96)
Values in mcg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)2.89Not reported0.5817.40Not reported
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)5.19Not reported0.6962.10Not reported
Week 36: Follow-up Visit 3 (n = 38, 53)
Values in mcg/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)1.08Not reported0.5251.40Not reported
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)2.02Not reported0.5333.90Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.70
        upper Limit
        80.40
        value
        15.60
      2. group Id
        OG001
        lower Limit
        0.65
        upper Limit
        107.00
        value
        22.35
    title
    Week 12: Follow-up Visit 1 (n = 117, 118)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.58
        upper Limit
        17.40
        value
        2.89
      2. group Id
        OG001
        lower Limit
        0.69
        upper Limit
        62.10
        value
        5.19
    title
    Week 24: Follow-up Visit 2 (n = 88, 96)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.52
        upper Limit
        51.40
        value
        1.08
      2. group Id
        OG001
        lower Limit
        0.53
        upper Limit
        33.90
        value
        2.02
    title
    Week 36: Follow-up Visit 3 (n = 38, 53)
denoms
  1. counts
    1. group Id
      OG000
      value
      117
    2. group Id
      OG001
      value
      118
    units
    Participants
dispersion Type
Full Range
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
MEDIAN
population Description
Safety Analysis Population included all participants who received at least one dose of rituximab, either IV or SC. Participants were analyzed as treated. 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
12 weeks, 24 weeks, and 36 weeks after the last rituximab administration (up to data cutoff of 11 Jan 2016 [up to 6 years])
title
Stage I and II (Pooled): Rituximab Levels 12 Weeks, 24 Weeks, and 36 Weeks After the Last Rituximab Administration
type
SECONDARY
unit Of Measure
mcg/mL

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Preserved source evidence · Not medical advice