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NCT01200758 · OUTCOME

Overall Survival (OS)

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
days
Interval / dispersion
95% Confidence Interval
Time frame
Baseline up to death (up to data cutoff of 31 Oct 2017 [up to 6 years])

What was measured

OS was defined as the time from randomization to death due to any cause. Participants without event were censored at the time of last follow-up information for survival, ie, at the last time known to be alive.

Analysis population: ITT population.

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 of rituximab IV infusion (375 mg/m\^2) + 7 cycles of rituximab 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 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)205
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)205

Reported measurements

Source class 1
Values in days · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)NANot reportedNANAData for median and corresponding 95% CI were not reached due to low number (\<10%) of participants with event of interest.
Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)NANot reportedNANAData for median and corresponding 95% CI were not reached due to low number (\<10%) of participants with event of interest.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Data for median and corresponding 95% CI were not reached due to low number (\<10%) of participants with event of interest.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Data for median and corresponding 95% CI were not reached due to low number (\<10%) of participants with event of interest.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      205
    2. group Id
      OG001
      value
      205
    units
    Participants
description
OS was defined as the time from randomization to death due to any cause. Participants without event were censored at the time of last follow-up information for survival, ie, at the last time known to be alive.
dispersion Type
95% Confidence Interval
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 of rituximab IV infusion (375 mg/m\^2) + 7 cycles of rituximab 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 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
ITT population.
reporting Status
POSTED
time Frame
Baseline up to death (up to data cutoff of 31 Oct 2017 [up to 6 years])
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
days

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice