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NCT01200758 · OUTCOME

Stage I: Maximum Serum Concentrations (Cmax) of IV and SC Rituximab

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 (Induction): Predose (within 2hr) up to data cutoff of 11 Apr 2012 [up to 26 months]) (See detailed timeframe in Outcome Measure description)

What was measured

Predose (within 2 hr) and 24 hrs postdose on Cy7 (D1,3,7,15), predose (0 hr) on Cy8 D1 (1 Cy=3 weeks); additionally within 15 minutes after end of infusion (infusion duration=30 minutes) on Cy7 D1 for rituximab IV (up to data cutoff of 11 Apr 2012 \[up to 26 months\])

Analysis population: Stage 1 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 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: Rituximab IV + Chemotherapy (CHOP/CVP)58
Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)59

Reported measurements

Source class 1
Values in mcg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)250.6319.66Not reportedNot reportedNot reported
Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)236.8231.45Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.872
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.015
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Geometric mean ratio
    param Value
    0.941
Complete source fields
analyses
  1. ci Lower Limit
    0.872
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.015
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Geometric mean ratio
    param Value
    0.941
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.66
        value
        250.63
      2. group Id
        OG001
        spread
        31.45
        value
        236.82
denoms
  1. counts
    1. group Id
      OG000
      value
      58
    2. group Id
      OG001
      value
      59
    units
    Participants
description
Predose (within 2 hr) and 24 hrs postdose on Cy7 (D1,3,7,15), predose (0 hr) on Cy8 D1 (1 Cy=3 weeks); additionally within 15 minutes after end of infusion (infusion duration=30 minutes) on Cy7 D1 for rituximab IV (up to data cutoff of 11 Apr 2012 \[up to 26 months\])
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: Rituximab IV + Chemotherapy (CHOP/CVP)
  2. 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 1 PK Evaluable Population. Here, number of participants analyzed = participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Stage I (Induction): Predose (within 2hr) up to data cutoff of 11 Apr 2012 [up to 26 months]) (See detailed timeframe in Outcome Measure description)
title
Stage I: Maximum Serum Concentrations (Cmax) of IV and SC Rituximab
type
SECONDARY
unit Of Measure
mcg/mL

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Preserved source evidence · Not medical advice