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NCT01332968 · OUTCOME

Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population)

A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Rituximab Plus Chemotherapy Followed by Obinutuzumab or Rituximab Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM) · Source last updated 2022-08-11

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

Measure
MEAN
Unit
units on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)

What was measured

The FACT-Lym Total Score for the follicular lymphoma population was derived from the following 5 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Social/Family Well-being (range: 0-28), Emotional Well-being (range: 0-24),Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym Total Score is the sum of all 5 individual subscales (range 0-168). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement.

Analysis population: The FL ITT population was defined as all randomized participants with follicular histology grouped according to their randomized treatment arm regardless of what treatments were actually received.

Groups in this outcome

Rituximab+Chemotherapy

Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.

Obinutuzumab+Chemotherapy

Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.

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

Analysis denominator · Participants

GroupSource count
Rituximab+Chemotherapy552
Obinutuzumab+Chemotherapy559

Reported measurements

Total Score, Baseline

Analysis denominator · Participants

GroupSource count
Rituximab+Chemotherapy552
Obinutuzumab+Chemotherapy559
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab+Chemotherapy127.4022.43Not reportedNot reportedNot reported
Obinutuzumab+Chemotherapy128.4222.16Not reportedNot reportedNot reported
Total Score Change, Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Rituximab+Chemotherapy499
Obinutuzumab+Chemotherapy484
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab+Chemotherapy1.9817.01Not reportedNot reportedNot reported
Obinutuzumab+Chemotherapy3.2117.12Not reportedNot reportedNot reported
Total Score Change, End Induction

Analysis denominator · Participants

GroupSource count
Rituximab+Chemotherapy471
Obinutuzumab+Chemotherapy471
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab+Chemotherapy4.1819.75Not reportedNot reportedNot reported
Obinutuzumab+Chemotherapy5.1020.03Not reportedNot reportedNot reported
Total Score Change, Maint Month 2

Analysis denominator · Participants

GroupSource count
Rituximab+Chemotherapy356
Obinutuzumab+Chemotherapy392
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab+Chemotherapy8.4019.16Not reportedNot reportedNot reported
Obinutuzumab+Chemotherapy8.1319.80Not reportedNot reportedNot reported
Total Score Change, Maint Month 12

Analysis denominator · Participants

GroupSource count
Rituximab+Chemotherapy358
Obinutuzumab+Chemotherapy396
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab+Chemotherapy8.8719.31Not reportedNot reportedNot reported
Obinutuzumab+Chemotherapy7.9019.55Not reportedNot reportedNot reported
Total Score Change, End Maint

Analysis denominator · Participants

GroupSource count
Rituximab+Chemotherapy401
Obinutuzumab+Chemotherapy433
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Rituximab+Chemotherapy7.4319.88Not reportedNot reportedNot reported
Obinutuzumab+Chemotherapy8.8020.57Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        22.43
        value
        127.40
      2. group Id
        OG001
        spread
        22.16
        value
        128.42
    denoms
    1. counts
      1. group Id
        OG000
        value
        552
      2. group Id
        OG001
        value
        559
      units
      Participants
    title
    Total Score, Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        17.01
        value
        1.98
      2. group Id
        OG001
        spread
        17.12
        value
        3.21
    denoms
    1. counts
      1. group Id
        OG000
        value
        499
      2. group Id
        OG001
        value
        484
      units
      Participants
    title
    Total Score Change, Cycle 3 Day 1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.75
        value
        4.18
      2. group Id
        OG001
        spread
        20.03
        value
        5.10
    denoms
    1. counts
      1. group Id
        OG000
        value
        471
      2. group Id
        OG001
        value
        471
      units
      Participants
    title
    Total Score Change, End Induction
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.16
        value
        8.40
      2. group Id
        OG001
        spread
        19.80
        value
        8.13
    denoms
    1. counts
      1. group Id
        OG000
        value
        356
      2. group Id
        OG001
        value
        392
      units
      Participants
    title
    Total Score Change, Maint Month 2
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.31
        value
        8.87
      2. group Id
        OG001
        spread
        19.55
        value
        7.90
    denoms
    1. counts
      1. group Id
        OG000
        value
        358
      2. group Id
        OG001
        value
        396
      units
      Participants
    title
    Total Score Change, Maint Month 12
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.88
        value
        7.43
      2. group Id
        OG001
        spread
        20.57
        value
        8.80
    denoms
    1. counts
      1. group Id
        OG000
        value
        401
      2. group Id
        OG001
        value
        433
      units
      Participants
    title
    Total Score Change, End Maint
denoms
  1. counts
    1. group Id
      OG000
      value
      552
    2. group Id
      OG001
      value
      559
    units
    Participants
description
The FACT-Lym Total Score for the follicular lymphoma population was derived from the following 5 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Social/Family Well-being (range: 0-28), Emotional Well-being (range: 0-24),Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym Total Score is the sum of all 5 individual subscales (range 0-168). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
    id
    OG000
    title
    Rituximab+Chemotherapy
  2. description
    Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
    id
    OG001
    title
    Obinutuzumab+Chemotherapy
param Type
MEAN
population Description
The FL ITT population was defined as all randomized participants with follicular histology grouped according to their randomized treatment arm regardless of what treatments were actually received.
reporting Status
POSTED
time Frame
Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)
title
Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population)
type
SECONDARY
unit Of Measure
units on a scale

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

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