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NCT03332017 · OUTCOME

Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL), Physical Functioning, Role Functioning, and Symptom Scores

A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma · Source last updated 2026-02-18

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

Measure
MEAN
Unit
Score on a scale
Interval / dispersion
Standard Deviation
Time frame
Baseline, Week 12, and Week 24

What was measured

The EORTC QLQ-C30 includes 30 questions covering 5 functional scales (physical, role, emotional, cognitive, social), 1 global health scale, 3 symptom scales (fatigue, nausea/vomiting, pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). Participants report their health over the past week. Most items use a 4-point scale (1 = Not at all to 4 = Very much), while 2 global QOL items use a 7-point scale (1 = Very poor to 7 = Excellent). Raw scores are linearly transformed to a 0-100 scale; higher GHS and functional scores and lower symptom scores indicate better quality of life.

Analysis population: ITT Analysis Set. Only participants with data at both baseline and each post-baseline visit were included in the calculation of change from baseline.

Groups in this outcome

Obinutuzumab

Obinutuzumab 1000 milligrams (mg) intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6; and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days.

Zanubrutinib + Obinutuzumab

Zanubrutinib 160 mg twice a day orally with or without food and obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6, and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days.

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

Analysis denominator · Participants

GroupSource count
Obinutuzumab72
Zanubrutinib + Obinutuzumab145

Reported measurements

Global Health Status/QOL: Week 12

Analysis denominator · Participants

GroupSource count
Obinutuzumab45
Zanubrutinib + Obinutuzumab116
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab-2.22216.9856Not reportedNot reportedNot reported
Zanubrutinib + Obinutuzumab4.02316.2440Not reportedNot reportedNot reported
Global Health Status/QOL: Week 24

Analysis denominator · Participants

GroupSource count
Obinutuzumab37
Zanubrutinib + Obinutuzumab97
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab4.95515.1458Not reportedNot reportedNot reported
Zanubrutinib + Obinutuzumab2.57717.3623Not reportedNot reportedNot reported
Physical Function: Week 12

Analysis denominator · Participants

GroupSource count
Obinutuzumab46
Zanubrutinib + Obinutuzumab117
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab-1.44913.2526Not reportedNot reportedNot reported
Zanubrutinib + Obinutuzumab0.36113.8192Not reportedNot reportedNot reported
Physical Function: Week 24

Analysis denominator · Participants

GroupSource count
Obinutuzumab37
Zanubrutinib + Obinutuzumab97
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab0.27010.2553Not reportedNot reportedNot reported
Zanubrutinib + Obinutuzumab0.41211.4186Not reportedNot reportedNot reported
Role Function: Week 12

Analysis denominator · Participants

GroupSource count
Obinutuzumab46
Zanubrutinib + Obinutuzumab116
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab1.81225.6347Not reportedNot reportedNot reported
Zanubrutinib + Obinutuzumab2.73022.9412Not reportedNot reportedNot reported
Role Function: Week 24

Analysis denominator · Participants

GroupSource count
Obinutuzumab37
Zanubrutinib + Obinutuzumab97
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab-0.90121.1352Not reportedNot reportedNot reported
Zanubrutinib + Obinutuzumab3.09317.4022Not reportedNot reportedNot reported
Fatigue: Week 12

Analysis denominator · Participants

GroupSource count
Obinutuzumab46
Zanubrutinib + Obinutuzumab117
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab2.65719.3424Not reportedNot reportedNot reported
Zanubrutinib + Obinutuzumab-1.94719.5647Not reportedNot reportedNot reported
Fatigue: Week 24

Analysis denominator · Participants

GroupSource count
Obinutuzumab37
Zanubrutinib + Obinutuzumab95
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab-0.15015.0722Not reportedNot reportedNot reported
Zanubrutinib + Obinutuzumab-2.29118.4911Not reportedNot reportedNot reported
Pain: Week 12

Analysis denominator · Participants

GroupSource count
Obinutuzumab46
Zanubrutinib + Obinutuzumab116
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab1.08721.1993Not reportedNot reportedNot reported
Zanubrutinib + Obinutuzumab-1.58022.9448Not reportedNot reportedNot reported
Pain: Week 24

Analysis denominator · Participants

GroupSource count
Obinutuzumab37
Zanubrutinib + Obinutuzumab97
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab-1.35123.0332Not reportedNot reportedNot reported
Zanubrutinib + Obinutuzumab-4.98316.3450Not reportedNot reportedNot reported
Nausea/Vomiting: Week 12

Analysis denominator · Participants

GroupSource count
Obinutuzumab46
Zanubrutinib + Obinutuzumab117
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab1.8127.2250Not reportedNot reportedNot reported
Zanubrutinib + Obinutuzumab-0.85510.9085Not reportedNot reportedNot reported
Nausea/Vomiting: Week 24

Analysis denominator · Participants

GroupSource count
Obinutuzumab37
Zanubrutinib + Obinutuzumab97
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab0.4504.7895Not reportedNot reportedNot reported
Zanubrutinib + Obinutuzumab-1.0318.9412Not reportedNot reportedNot reported
Diarrhea: Week 12

Analysis denominator · Participants

GroupSource count
Obinutuzumab44
Zanubrutinib + Obinutuzumab115
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab0.75825.4049Not reportedNot reportedNot reported
Zanubrutinib + Obinutuzumab2.60919.3197Not reportedNot reportedNot reported
Diarrhea: Week 24

Analysis denominator · Participants

GroupSource count
Obinutuzumab37
Zanubrutinib + Obinutuzumab97
Values in Score on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Obinutuzumab0.90116.6416Not reportedNot reportedNot reported
Zanubrutinib + Obinutuzumab0.0020.4124Not reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    0.6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    12.3
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    2.95
    group Description
    Global Health Status/QoL (Week 12)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \[2-3 vs \>3\] and rituximab-refractory status \[yes vs no\]). Random participant effects were included as a random intercept.
    non Inferiority Type
    OTHER
    p Value
    0.0302
    p Value Comment
    Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons. Statistical significance predefined at α = 0.05.
    param Type
    Least squares mean difference
    param Value
    6.4
    statistical Method
    Mixed Models Analysis
  2. ci Lower Limit
    -6.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    6.0
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    3.18
    group Description
    Global Health Status/QoL (Week 24)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \[2-3 vs \>3\] and rituximab-refractory status \[yes vs no\]). Random participant effects were included as a random intercept.
    non Inferiority Type
    OTHER
    p Value
    0.9356
    p Value Comment
    Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.
    param Type
    Least squares mean difference
    param Value
    -0.3
    statistical Method
    Mixed Models Analysis
  3. ci Lower Limit
    -2.1
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    6.5
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    2.21
    group Description
    Physical Function (Week 12)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \[2-3 vs \>3\] and rituximab-refractory status \[yes vs no\]). Random participant effects were included as a random intercept.
    non Inferiority Type
    OTHER
    p Value
    0.3161
    p Value Comment
    Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.
    param Type
    Least squares mean difference
    param Value
    2.2
    statistical Method
    Mixed Models Analysis
  4. ci Lower Limit
    -3.8
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.5
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    2.35
    group Description
    Physical Function (Week 24)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \[2-3 vs \>3\] and rituximab-refractory status \[yes vs no\]). Random participant effects were included as a random intercept.
    non Inferiority Type
    OTHER
    p Value
    0.7199
    p Value Comment
    Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.
    param Type
    Least squares mean difference
    param Value
    0.8
    statistical Method
    Mixed Models Analysis
  5. ci Lower Limit
    -6.6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    8.1
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    3.72
    group Description
    Role Function (Week 12)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \[2-3 vs \>3\] and rituximab-refractory status \[yes vs no\]). Random participant effects were included as a random intercept.
    non Inferiority Type
    OTHER
    p Value
    0.8424
    p Value Comment
    Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.
    param Type
    Least squares mean difference
    param Value
    0.7
    statistical Method
    Mixed Models Analysis
  6. ci Lower Limit
    -2.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    13.5
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    4.02
    group Description
    Role Function (Week 24)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \[2-3 vs \>3\] and rituximab-refractory status \[yes vs no\]). Random participant effects were included as a random intercept.
    non Inferiority Type
    OTHER
    p Value
    0.1637
    p Value Comment
    Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.
    param Type
    Least squares mean difference
    param Value
    5.6
    statistical Method
    Mixed Models Analysis
  7. ci Lower Limit
    -11.1
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.9
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    3.28
    group Description
    Fatigue (Week 12)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \[2-3 vs \>3\] and rituximab-refractory status \[yes vs no\]). Random participant effects were included as a random intercept.
    non Inferiority Type
    OTHER
    p Value
    0.1614
    p Value Comment
    Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.
    param Type
    Least Squares Mean Difference
    param Value
    -4.6
    statistical Method
    Mixed Models Analysis
  8. ci Lower Limit
    -11.6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.2
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    3.50
    group Description
    Fatigue (Week 24)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \[2-3 vs \>3\] and rituximab-refractory status \[yes vs no\]). Random participant effects were included as a random intercept.
    non Inferiority Type
    OTHER
    p Value
    0.1817
    p Value Comment
    Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.
    param Type
    Least squares mean difference
    param Value
    -4.7
    statistical Method
    Mixed Models Analysis
  9. ci Lower Limit
    -9.2
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.2
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    3.65
    group Description
    Pain (Week 12)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \[2-3 vs \>3\] and rituximab-refractory status \[yes vs no\]). Random participant effects were included as a random intercept.
    non Inferiority Type
    OTHER
    p Value
    0.5870
    p Value Comment
    Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.
    param Type
    Least squares mean difference
    param Value
    -2.0
    statistical Method
    Mixed Models Analysis
  10. ci Lower Limit
    -12.6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.8
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    3.91
    group Description
    Pain (Week 24)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \[2-3 vs \>3\] and rituximab-refractory status \[yes vs no\]). Random participant effects were included as a random intercept.
    non Inferiority Type
    OTHER
    p Value
    0.2148
    p Value Comment
    Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.
    param Type
    Least squares mean difference
    param Value
    -4.9
    statistical Method
    Mixed Models Analysis
  11. ci Lower Limit
    -5.9
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.3
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    1.58
    group Description
    Nausea/Vomiting (Week 12)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \[2-3 vs \>3\] and rituximab-refractory status \[yes vs no\]). Random participant effects were included as a random intercept.
    non Inferiority Type
    OTHER
    p Value
    0.0729
    p Value Comment
    Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.
    param Type
    Least squares mean difference
    param Value
    -2.8
    statistical Method
    Mixed Models Analysis
  12. ci Lower Limit
    -5.2
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.5
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    1.69
    group Description
    Nausea/Vomiting (Week 24)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \[2-3 vs \>3\] and rituximab-refractory status \[yes vs no\]). Random participant effects were included as a random intercept.
    non Inferiority Type
    OTHER
    p Value
    0.2766
    p Value Comment
    Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.
    param Type
    Least squares mean difference
    param Value
    -1.8
    statistical Method
    Mixed Models Analysis
Complete source fields
analyses
  1. ci Lower Limit
    0.6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    12.3
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    2.95
    group Description
    Global Health Status/QoL (Week 12)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \[2-3 vs \>3\] and rituximab-refractory status \[yes vs no\]). Random participant effects were included as a random intercept.
    non Inferiority Type
    OTHER
    p Value
    0.0302
    p Value Comment
    Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons. Statistical significance predefined at α = 0.05.
    param Type
    Least squares mean difference
    param Value
    6.4
    statistical Method
    Mixed Models Analysis
  2. ci Lower Limit
    -6.5
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    6.0
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    3.18
    group Description
    Global Health Status/QoL (Week 24)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \[2-3 vs \>3\] and rituximab-refractory status \[yes vs no\]). Random participant effects were included as a random intercept.
    non Inferiority Type
    OTHER
    p Value
    0.9356
    p Value Comment
    Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.
    param Type
    Least squares mean difference
    param Value
    -0.3
    statistical Method
    Mixed Models Analysis
  3. ci Lower Limit
    -2.1
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    6.5
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    2.21
    group Description
    Physical Function (Week 12)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \[2-3 vs \>3\] and rituximab-refractory status \[yes vs no\]). Random participant effects were included as a random intercept.
    non Inferiority Type
    OTHER
    p Value
    0.3161
    p Value Comment
    Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.
    param Type
    Least squares mean difference
    param Value
    2.2
    statistical Method
    Mixed Models Analysis
  4. ci Lower Limit
    -3.8
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.5
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    2.35
    group Description
    Physical Function (Week 24)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \[2-3 vs \>3\] and rituximab-refractory status \[yes vs no\]). Random participant effects were included as a random intercept.
    non Inferiority Type
    OTHER
    p Value
    0.7199
    p Value Comment
    Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.
    param Type
    Least squares mean difference
    param Value
    0.8
    statistical Method
    Mixed Models Analysis
  5. ci Lower Limit
    -6.6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    8.1
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    3.72
    group Description
    Role Function (Week 12)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \[2-3 vs \>3\] and rituximab-refractory status \[yes vs no\]). Random participant effects were included as a random intercept.
    non Inferiority Type
    OTHER
    p Value
    0.8424
    p Value Comment
    Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.
    param Type
    Least squares mean difference
    param Value
    0.7
    statistical Method
    Mixed Models Analysis
  6. ci Lower Limit
    -2.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    13.5
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    4.02
    group Description
    Role Function (Week 24)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \[2-3 vs \>3\] and rituximab-refractory status \[yes vs no\]). Random participant effects were included as a random intercept.
    non Inferiority Type
    OTHER
    p Value
    0.1637
    p Value Comment
    Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.
    param Type
    Least squares mean difference
    param Value
    5.6
    statistical Method
    Mixed Models Analysis
  7. ci Lower Limit
    -11.1
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.9
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    3.28
    group Description
    Fatigue (Week 12)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \[2-3 vs \>3\] and rituximab-refractory status \[yes vs no\]). Random participant effects were included as a random intercept.
    non Inferiority Type
    OTHER
    p Value
    0.1614
    p Value Comment
    Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.
    param Type
    Least Squares Mean Difference
    param Value
    -4.6
    statistical Method
    Mixed Models Analysis
  8. ci Lower Limit
    -11.6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.2
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    3.50
    group Description
    Fatigue (Week 24)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \[2-3 vs \>3\] and rituximab-refractory status \[yes vs no\]). Random participant effects were included as a random intercept.
    non Inferiority Type
    OTHER
    p Value
    0.1817
    p Value Comment
    Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.
    param Type
    Least squares mean difference
    param Value
    -4.7
    statistical Method
    Mixed Models Analysis
  9. ci Lower Limit
    -9.2
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    5.2
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    3.65
    group Description
    Pain (Week 12)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \[2-3 vs \>3\] and rituximab-refractory status \[yes vs no\]). Random participant effects were included as a random intercept.
    non Inferiority Type
    OTHER
    p Value
    0.5870
    p Value Comment
    Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.
    param Type
    Least squares mean difference
    param Value
    -2.0
    statistical Method
    Mixed Models Analysis
  10. ci Lower Limit
    -12.6
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    2.8
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    3.91
    group Description
    Pain (Week 24)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \[2-3 vs \>3\] and rituximab-refractory status \[yes vs no\]). Random participant effects were included as a random intercept.
    non Inferiority Type
    OTHER
    p Value
    0.2148
    p Value Comment
    Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.
    param Type
    Least squares mean difference
    param Value
    -4.9
    statistical Method
    Mixed Models Analysis
  11. ci Lower Limit
    -5.9
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.3
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    1.58
    group Description
    Nausea/Vomiting (Week 12)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \[2-3 vs \>3\] and rituximab-refractory status \[yes vs no\]). Random participant effects were included as a random intercept.
    non Inferiority Type
    OTHER
    p Value
    0.0729
    p Value Comment
    Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.
    param Type
    Least squares mean difference
    param Value
    -2.8
    statistical Method
    Mixed Models Analysis
  12. ci Lower Limit
    -5.2
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.5
    dispersion Type
    STANDARD_ERROR_OF_MEAN
    dispersion Value
    1.69
    group Description
    Nausea/Vomiting (Week 24)
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    The mixed model for repeated measures (MMRM) included the following fixed effects: treatment, visit (categorical), treatment-by-visit interaction, baseline QLQ-C30 domain score (continuous), and the randomization stratification factors (number of prior lines of therapy \[2-3 vs \>3\] and rituximab-refractory status \[yes vs no\]). Random participant effects were included as a random intercept.
    non Inferiority Type
    OTHER
    p Value
    0.2766
    p Value Comment
    Two-sided p-value from mixed model for repeated measures. No adjustment for multiple comparisons.
    param Type
    Least squares mean difference
    param Value
    -1.8
    statistical Method
    Mixed Models Analysis
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.9856
        value
        -2.222
      2. group Id
        OG001
        spread
        16.2440
        value
        4.023
    denoms
    1. counts
      1. group Id
        OG000
        value
        45
      2. group Id
        OG001
        value
        116
      units
      Participants
    title
    Global Health Status/QOL: Week 12
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.1458
        value
        4.955
      2. group Id
        OG001
        spread
        17.3623
        value
        2.577
    denoms
    1. counts
      1. group Id
        OG000
        value
        37
      2. group Id
        OG001
        value
        97
      units
      Participants
    title
    Global Health Status/QOL: Week 24
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        13.2526
        value
        -1.449
      2. group Id
        OG001
        spread
        13.8192
        value
        0.361
    denoms
    1. counts
      1. group Id
        OG000
        value
        46
      2. group Id
        OG001
        value
        117
      units
      Participants
    title
    Physical Function: Week 12
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.2553
        value
        0.270
      2. group Id
        OG001
        spread
        11.4186
        value
        0.412
    denoms
    1. counts
      1. group Id
        OG000
        value
        37
      2. group Id
        OG001
        value
        97
      units
      Participants
    title
    Physical Function: Week 24
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        25.6347
        value
        1.812
      2. group Id
        OG001
        spread
        22.9412
        value
        2.730
    denoms
    1. counts
      1. group Id
        OG000
        value
        46
      2. group Id
        OG001
        value
        116
      units
      Participants
    title
    Role Function: Week 12
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.1352
        value
        -0.901
      2. group Id
        OG001
        spread
        17.4022
        value
        3.093
    denoms
    1. counts
      1. group Id
        OG000
        value
        37
      2. group Id
        OG001
        value
        97
      units
      Participants
    title
    Role Function: Week 24
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        19.3424
        value
        2.657
      2. group Id
        OG001
        spread
        19.5647
        value
        -1.947
    denoms
    1. counts
      1. group Id
        OG000
        value
        46
      2. group Id
        OG001
        value
        117
      units
      Participants
    title
    Fatigue: Week 12
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.0722
        value
        -0.150
      2. group Id
        OG001
        spread
        18.4911
        value
        -2.291
    denoms
    1. counts
      1. group Id
        OG000
        value
        37
      2. group Id
        OG001
        value
        95
      units
      Participants
    title
    Fatigue: Week 24
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.1993
        value
        1.087
      2. group Id
        OG001
        spread
        22.9448
        value
        -1.580
    denoms
    1. counts
      1. group Id
        OG000
        value
        46
      2. group Id
        OG001
        value
        116
      units
      Participants
    title
    Pain: Week 12
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.0332
        value
        -1.351
      2. group Id
        OG001
        spread
        16.3450
        value
        -4.983
    denoms
    1. counts
      1. group Id
        OG000
        value
        37
      2. group Id
        OG001
        value
        97
      units
      Participants
    title
    Pain: Week 24
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.2250
        value
        1.812
      2. group Id
        OG001
        spread
        10.9085
        value
        -0.855
    denoms
    1. counts
      1. group Id
        OG000
        value
        46
      2. group Id
        OG001
        value
        117
      units
      Participants
    title
    Nausea/Vomiting: Week 12
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.7895
        value
        0.450
      2. group Id
        OG001
        spread
        8.9412
        value
        -1.031
    denoms
    1. counts
      1. group Id
        OG000
        value
        37
      2. group Id
        OG001
        value
        97
      units
      Participants
    title
    Nausea/Vomiting: Week 24
denoms
  1. counts
    1. group Id
      OG000
      value
      72
    2. group Id
      OG001
      value
      145
    units
    Participants
description
The EORTC QLQ-C30 includes 30 questions covering 5 functional scales (physical, role, emotional, cognitive, social), 1 global health scale, 3 symptom scales (fatigue, nausea/vomiting, pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). Participants report their health over the past week. Most items use a 4-point scale (1 = Not at all to 4 = Very much), while 2 global QOL items use a 7-point scale (1 = Very poor to 7 = Excellent). Raw scores are linearly transformed to a 0-100 scale; higher GHS and functional scores and lower symptom scores indicate better quality of life.
dispersion Type
Standard Deviation
groups
  1. description
    Obinutuzumab 1000 milligrams (mg) intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6; and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days.
    id
    OG000
    title
    Obinutuzumab
  2. description
    Zanubrutinib 160 mg twice a day orally with or without food and obinutuzumab 1000 mg intravenously on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycles 2 to 6, and then every 8 weeks for an additional 24 months or until disease progression. Each treatment cycle was 28 days.
    id
    OG001
    title
    Zanubrutinib + Obinutuzumab
param Type
MEAN
population Description
ITT Analysis Set. Only participants with data at both baseline and each post-baseline visit were included in the calculation of change from baseline.
reporting Status
POSTED
time Frame
Baseline, Week 12, and Week 24
title
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL), Physical Functioning, Role Functioning, and Symptom Scores
type
SECONDARY
unit Of Measure
Score on a scale

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