NCT03734016 · OUTCOME
Change From Baseline in EORTC QLQ-C30 Symptom Scales of Fatigue, Nausea and Vomiting, Pain, and Diarrhoea
A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia · Source last updated 2025-03-30
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- score on a scale
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline and Weeks 24 and 48
What was measured
The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. Lower scores in symptom scales indicate better quality of life.
Analysis population: Participants in the ITT Analysis Set who completed the EORTC QLQ-C30 at Baseline
Groups in this outcome
Zanubrutinib
Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
Ibrutinib
Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Zanubrutinib | 315 |
|---|
| Ibrutinib | 313 |
|---|
Reported measurements
Fatigue Symptom Scale at Week 24
Values in score on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Zanubrutinib | -12.54 | Not reported | -14.47 | -10.60 | Not reported |
|---|
| Ibrutinib | -10.63 | Not reported | -12.63 | -8.62 | Not reported |
|---|
Fatigue Symptom Scale at Week 48
Values in score on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Zanubrutinib | -11.13 | Not reported | -13.19 | -9.08 | Not reported |
|---|
| Ibrutinib | -10.78 | Not reported | -12.93 | -8.63 | Not reported |
|---|
Nausea and Vomiting Symptom Scale at Week 24
Values in score on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Zanubrutinib | -1.21 | Not reported | -2.03 | -0.38 | Not reported |
|---|
| Ibrutinib | -0.92 | Not reported | -1.77 | -0.07 | Not reported |
|---|
Nausea and Vomiting Symptom Scale at Week 48
Values in score on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Zanubrutinib | -0.92 | Not reported | -1.94 | 0.10 | Not reported |
|---|
| Ibrutinib | -0.40 | Not reported | -1.47 | 0.66 | Not reported |
|---|
Pain Symptom Scale at Week 24
Values in score on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Zanubrutinib | -5.06 | Not reported | -7.21 | -2.91 | Not reported |
|---|
| Ibrutinib | -3.63 | Not reported | -5.85 | -1.42 | Not reported |
|---|
Pain Symptom Scale at Week 48
Values in score on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Zanubrutinib | -5.18 | Not reported | -7.38 | -2.97 | Not reported |
|---|
| Ibrutinib | -2.75 | Not reported | -5.06 | -0.44 | Not reported |
|---|
Diarrhoea Symptom Scale at Week 24
Values in score on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Zanubrutinib | -2.11 | Not reported | -3.80 | -0.42 | Not reported |
|---|
| Ibrutinib | -0.52 | Not reported | -2.27 | 1.22 | Not reported |
|---|
Diarrhoea Symptom Scale at Week 48
Values in score on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Zanubrutinib | -3.23 | Not reported | -4.79 | -1.66 | Not reported |
|---|
| Ibrutinib | -1.38 | Not reported | -3.03 | 0.27 | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- ci Lower Limit
- -4.70
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.87
- group Description
- Analysis of Change from Baseline in EORTC QLQ-C30 Fatigue Symptom Scale at Week 24.
A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.
- non Inferiority Type
- OTHER
- p Value
- 0.1778
- param Type
- LS Mean Difference
- param Value
- -1.91
- statistical Method
- Mixed model for repeated measures (MMRM)
- ci Lower Limit
- -3.32
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.62
- group Description
- Analysis of Change from Baseline in EORTC QLQ-C30 Fatigue Symptom Scale at Week 48.
A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.
- non Inferiority Type
- OTHER
- p Value
- 0.8174
- param Type
- LS Mean Difference
- param Value
- -0.35
- statistical Method
- Mixed model for repeated measures (MMRM)
- ci Lower Limit
- -1.48
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.89
- group Description
- Analysis of Change from Baseline in EORTC QLQ-C30 Nausea and Vomiting Symptom Scale at Week 24.
A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.
- non Inferiority Type
- OTHER
- p Value
- 0.6294
- param Type
- LS Mean Difference
- param Value
- -0.29
- statistical Method
- Mixed model for repeated measures (MMRM)
- ci Lower Limit
- -1.99
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.96
- group Description
- Analysis of Change from Baseline in EORTC QLQ-C30 Nausea and Vomiting Symptom Scale at Week 48.
A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.
- non Inferiority Type
- OTHER
- p Value
- 0.4933
- param Type
- LS Mean Difference
- param Value
- -0.51
- statistical Method
- Mixed model for repeated measures (MMRM)
- ci Lower Limit
- -4.51
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.66
- group Description
- Analysis of Change from Baseline in EORTC QLQ-C30 Pain Symptom Scale at Week 24.
A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.
- non Inferiority Type
- OTHER
- p Value
- 0.3643
- param Type
- LS Mean Difference
- param Value
- -1.43
- statistical Method
- Mixed model for repeated measures (MMRM)
- ci Lower Limit
- -5.62
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.77
- group Description
- Analysis of Change from Baseline in EORTC QLQ-C30 Pain Symptom Scale at Week 48.
A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.
- non Inferiority Type
- OTHER
- p Value
- 0.1363
- param Type
- LS Mean Difference
- param Value
- -2.43
- statistical Method
- Mixed model for repeated measures (MMRM)
- ci Lower Limit
- -4.01
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.84
- group Description
- Analysis of Change from Baseline in EORTC QLQ-C30 Diarrhoea Symptom Scale at Week 24.
A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.
- non Inferiority Type
- OTHER
- p Value
- 0.2001
- param Type
- LS Mean Difference
- param Value
- -1.59
- statistical Method
- Mixed model for repeated measures (MMRM)
- ci Lower Limit
- -4.12
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.43
- group Description
- Analysis of Change from Baseline in EORTC QLQ-C30 Diarrhoea Symptom Scale at Week 48.
A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.
- non Inferiority Type
- OTHER
- p Value
- 0.1121
- param Type
- LS Mean Difference
- param Value
- -1.85
- statistical Method
- Mixed model for repeated measures (MMRM)
Complete source fields
- analyses
- ci Lower Limit
- -4.70
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.87
- group Description
- Analysis of Change from Baseline in EORTC QLQ-C30 Fatigue Symptom Scale at Week 24.
A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.
- non Inferiority Type
- OTHER
- p Value
- 0.1778
- param Type
- LS Mean Difference
- param Value
- -1.91
- statistical Method
- Mixed model for repeated measures (MMRM)
- ci Lower Limit
- -3.32
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.62
- group Description
- Analysis of Change from Baseline in EORTC QLQ-C30 Fatigue Symptom Scale at Week 48.
A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.
- non Inferiority Type
- OTHER
- p Value
- 0.8174
- param Type
- LS Mean Difference
- param Value
- -0.35
- statistical Method
- Mixed model for repeated measures (MMRM)
- ci Lower Limit
- -1.48
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.89
- group Description
- Analysis of Change from Baseline in EORTC QLQ-C30 Nausea and Vomiting Symptom Scale at Week 24.
A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.
- non Inferiority Type
- OTHER
- p Value
- 0.6294
- param Type
- LS Mean Difference
- param Value
- -0.29
- statistical Method
- Mixed model for repeated measures (MMRM)
- ci Lower Limit
- -1.99
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.96
- group Description
- Analysis of Change from Baseline in EORTC QLQ-C30 Nausea and Vomiting Symptom Scale at Week 48.
A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.
- non Inferiority Type
- OTHER
- p Value
- 0.4933
- param Type
- LS Mean Difference
- param Value
- -0.51
- statistical Method
- Mixed model for repeated measures (MMRM)
- ci Lower Limit
- -4.51
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.66
- group Description
- Analysis of Change from Baseline in EORTC QLQ-C30 Pain Symptom Scale at Week 24.
A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.
- non Inferiority Type
- OTHER
- p Value
- 0.3643
- param Type
- LS Mean Difference
- param Value
- -1.43
- statistical Method
- Mixed model for repeated measures (MMRM)
- ci Lower Limit
- -5.62
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.77
- group Description
- Analysis of Change from Baseline in EORTC QLQ-C30 Pain Symptom Scale at Week 48.
A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.
- non Inferiority Type
- OTHER
- p Value
- 0.1363
- param Type
- LS Mean Difference
- param Value
- -2.43
- statistical Method
- Mixed model for repeated measures (MMRM)
- ci Lower Limit
- -4.01
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.84
- group Description
- Analysis of Change from Baseline in EORTC QLQ-C30 Diarrhoea Symptom Scale at Week 24.
A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.
- non Inferiority Type
- OTHER
- p Value
- 0.2001
- param Type
- LS Mean Difference
- param Value
- -1.59
- statistical Method
- Mixed model for repeated measures (MMRM)
- ci Lower Limit
- -4.12
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.43
- group Description
- Analysis of Change from Baseline in EORTC QLQ-C30 Diarrhoea Symptom Scale at Week 48.
A linear mixed model for repeated measures (MMRM) includes the repeated measurement of the change from baseline as the dependent variable, and the treatment arm by assessment timepoint interaction, and baseline score as a covariate with an unstructured covariance matrix.
- non Inferiority Type
- OTHER
- p Value
- 0.1121
- param Type
- LS Mean Difference
- param Value
- -1.85
- statistical Method
- Mixed model for repeated measures (MMRM)
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -14.47
- upper Limit
- -10.60
- value
- -12.54
- group Id
- OG001
- lower Limit
- -12.63
- upper Limit
- -8.62
- value
- -10.63
- title
- Fatigue Symptom Scale at Week 24
- categories
- measurements
- group Id
- OG000
- lower Limit
- -13.19
- upper Limit
- -9.08
- value
- -11.13
- group Id
- OG001
- lower Limit
- -12.93
- upper Limit
- -8.63
- value
- -10.78
- title
- Fatigue Symptom Scale at Week 48
- categories
- measurements
- group Id
- OG000
- lower Limit
- -2.03
- upper Limit
- -0.38
- value
- -1.21
- group Id
- OG001
- lower Limit
- -1.77
- upper Limit
- -0.07
- value
- -0.92
- title
- Nausea and Vomiting Symptom Scale at Week 24
- categories
- measurements
- group Id
- OG000
- lower Limit
- -1.94
- upper Limit
- 0.10
- value
- -0.92
- group Id
- OG001
- lower Limit
- -1.47
- upper Limit
- 0.66
- value
- -0.40
- title
- Nausea and Vomiting Symptom Scale at Week 48
- categories
- measurements
- group Id
- OG000
- lower Limit
- -7.21
- upper Limit
- -2.91
- value
- -5.06
- group Id
- OG001
- lower Limit
- -5.85
- upper Limit
- -1.42
- value
- -3.63
- title
- Pain Symptom Scale at Week 24
- categories
- measurements
- group Id
- OG000
- lower Limit
- -7.38
- upper Limit
- -2.97
- value
- -5.18
- group Id
- OG001
- lower Limit
- -5.06
- upper Limit
- -0.44
- value
- -2.75
- title
- Pain Symptom Scale at Week 48
- categories
- measurements
- group Id
- OG000
- lower Limit
- -3.80
- upper Limit
- -0.42
- value
- -2.11
- group Id
- OG001
- lower Limit
- -2.27
- upper Limit
- 1.22
- value
- -0.52
- title
- Diarrhoea Symptom Scale at Week 24
- categories
- measurements
- group Id
- OG000
- lower Limit
- -4.79
- upper Limit
- -1.66
- value
- -3.23
- group Id
- OG001
- lower Limit
- -3.03
- upper Limit
- 0.27
- value
- -1.38
- title
- Diarrhoea Symptom Scale at Week 48
- denoms
- counts
- group Id
- OG000
- value
- 315
- group Id
- OG001
- value
- 313
- units
- Participants
- description
- The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. Lower scores in symptom scales indicate better quality of life.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 160 mg zanubrutinib orally twice daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
- id
- OG000
- title
- Zanubrutinib
- description
- Participants received ibrutinib 420 mg orally once daily until disease progression, intolerable toxicity, initiation of alternative anticancer therapy, investigator/Sponsor decision, need for prohibited medication, study withdrawal, or pregnancy.
- id
- OG001
- title
- Ibrutinib
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Participants in the ITT Analysis Set who completed the EORTC QLQ-C30 at Baseline
- reporting Status
- POSTED
- time Frame
- Baseline and Weeks 24 and 48
- title
- Change From Baseline in EORTC QLQ-C30 Symptom Scales of Fatigue, Nausea and Vomiting, Pain, and Diarrhoea
- type
- SECONDARY
- unit Of Measure
- score on a scale
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Preserved source evidence · Not medical advice
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