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NCT01059630 · OUTCOME

Overall Survival (OS)

A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN) · Source last updated 2020-01-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Baseline until death (up to 8.5 years overall)

What was measured

OS was defined as the time between the date of randomization and the date of death from any cause. OS was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley.

Analysis population: ITT population.

Groups in this outcome

Bendamustine Alone

Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.

Obinutuzumab + Bendamustine

Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Bendamustine Alone209
Obinutuzumab + Bendamustine204

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Bendamustine Alone65.6Not reported48.587.8Not reported
Obinutuzumab + Bendamustine88.3Not reported71.1NAData could not be estimated due to higher (\>50%) number of censored participants.

Source statistical analyses

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

  1. ci Lower Limit
    0.57
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.03
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0810
    param Type
    Hazard Ratio (HR)
    param Value
    0.77
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.57
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.03
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0810
    param Type
    Hazard Ratio (HR)
    param Value
    0.77
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        48.5
        upper Limit
        87.8
        value
        65.6
      2. comment
        Data could not be estimated due to higher (\>50%) number of censored participants.
        group Id
        OG001
        lower Limit
        71.1
        upper Limit
        NA
        value
        88.3
denoms
  1. counts
    1. group Id
      OG000
      value
      209
    2. group Id
      OG001
      value
      204
    units
    Participants
description
OS was defined as the time between the date of randomization and the date of death from any cause. OS was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
    id
    OG000
    title
    Bendamustine Alone
  2. description
    Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
    id
    OG001
    title
    Obinutuzumab + Bendamustine
param Type
MEDIAN
population Description
ITT population.
reporting Status
POSTED
time Frame
Baseline until death (up to 8.5 years overall)
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Independent clinical review pending · Not medical advice