TriangleNCT03734016 · 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 and Role Functioning Scores
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. Higher scores in GHS and functional 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 | Source count |
|---|---|
| Zanubrutinib | 315 |
| Ibrutinib | 313 |
Reported measurements
GHS/QoL Scale at Week 24
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Zanubrutinib | 8.18 | Not reported | 6.25 | 10.12 | Not reported |
| Ibrutinib | 5.18 | Not reported | 3.20 | 7.17 | Not reported |
GHS/QoL Scale at Week 48
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Zanubrutinib | 7.28 | Not reported | 5.41 | 9.15 | Not reported |
| Ibrutinib | 5.93 | Not reported | 3.97 | 7.89 | Not reported |
Physical Functioning Scale at Week 24
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Zanubrutinib | 6.55 | Not reported | 4.96 | 8.15 | Not reported |
| Ibrutinib | 4.73 | Not reported | 3.08 | 6.38 | Not reported |
Physical Functioning Scale at Week 48
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Zanubrutinib | 5.46 | Not reported | 3.87 | 7.04 | Not reported |
| Ibrutinib | 4.31 | Not reported | 2.65 | 5.97 | Not reported |
Role Functioning Scale at Week 24
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Zanubrutinib | 6.95 | Not reported | 4.85 | 9.06 | Not reported |
| Ibrutinib | 6.32 | Not reported | 4.14 | 8.50 | Not reported |
Role Functioning Scale at Week 48
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Zanubrutinib | 6.81 | Not reported | 4.61 | 9.02 | Not reported |
| Ibrutinib | 5.01 | Not reported | 2.69 | 7.33 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.23
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.77
- group Description
- Analysis of Change from Baseline in EORTC QLQ-C30 GHS/QOL 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.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0338
- param Type
- Least Squares (LS) Mean Difference
- param Value
- 3.00
- statistical Method
- Mixed model for repeated measures (MMRM)
- ci Lower Limit
- -1.37
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.06
- group Description
- Analysis of Change from Baseline in EORTC QLQ-C30 GHS/QOL 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.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.3304
- param Type
- LS Mean Difference
- param Value
- 1.34
- statistical Method
- Mixed model for repeated measures (MMRM)
- ci Lower Limit
- -0.47
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.12
- group Description
- Analysis of Change from Baseline in EORTC QLQ-C30 Physical Functioning 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.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.1189
- param Type
- LS Mean Difference
- param Value
- 1.82
- statistical Method
- Mixed model for repeated measures (MMRM)
- ci Lower Limit
- -1.15
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.44
- group Description
- Analysis of Change from Baseline in EORTC QLQ-C30 Physical Functioning 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.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.3274
- param Type
- LS Mean Difference
- param Value
- 1.15
- statistical Method
- Mixed model for repeated measures (MMRM)
- ci Lower Limit
- -2.40
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.66
- group Description
- Analysis of Change from Baseline in EORTC QLQ-C30 Role Functioning 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.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.6821
- param Type
- LS Mean Difference
- param Value
- 0.63
- statistical Method
- Mixed model for repeated measures (MMRM)
- ci Lower Limit
- -1.40
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.00
- group Description
- Analysis of Change from Baseline in EORTC QLQ-C30 Role Functioning 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.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.2701
- param Type
- LS Mean Difference
- param Value
- 1.80
- statistical Method
- Mixed model for repeated measures (MMRM)
Complete source fields
- analyses
- ci Lower Limit
- 0.23
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.77
- group Description
- Analysis of Change from Baseline in EORTC QLQ-C30 GHS/QOL 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.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0338
- param Type
- Least Squares (LS) Mean Difference
- param Value
- 3.00
- statistical Method
- Mixed model for repeated measures (MMRM)
- ci Lower Limit
- -1.37
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.06
- group Description
- Analysis of Change from Baseline in EORTC QLQ-C30 GHS/QOL 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.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.3304
- param Type
- LS Mean Difference
- param Value
- 1.34
- statistical Method
- Mixed model for repeated measures (MMRM)
- ci Lower Limit
- -0.47
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.12
- group Description
- Analysis of Change from Baseline in EORTC QLQ-C30 Physical Functioning 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.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.1189
- param Type
- LS Mean Difference
- param Value
- 1.82
- statistical Method
- Mixed model for repeated measures (MMRM)
- ci Lower Limit
- -1.15
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.44
- group Description
- Analysis of Change from Baseline in EORTC QLQ-C30 Physical Functioning 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.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.3274
- param Type
- LS Mean Difference
- param Value
- 1.15
- statistical Method
- Mixed model for repeated measures (MMRM)
- ci Lower Limit
- -2.40
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.66
- group Description
- Analysis of Change from Baseline in EORTC QLQ-C30 Role Functioning 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.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.6821
- param Type
- LS Mean Difference
- param Value
- 0.63
- statistical Method
- Mixed model for repeated measures (MMRM)
- ci Lower Limit
- -1.40
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.00
- group Description
- Analysis of Change from Baseline in EORTC QLQ-C30 Role Functioning 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.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.2701
- param Type
- LS Mean Difference
- param Value
- 1.80
- statistical Method
- Mixed model for repeated measures (MMRM)
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.25
- upper Limit
- 10.12
- value
- 8.18
- group Id
- OG001
- lower Limit
- 3.20
- upper Limit
- 7.17
- value
- 5.18
- title
- GHS/QoL Scale at Week 24
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.41
- upper Limit
- 9.15
- value
- 7.28
- group Id
- OG001
- lower Limit
- 3.97
- upper Limit
- 7.89
- value
- 5.93
- title
- GHS/QoL Scale at Week 48
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.96
- upper Limit
- 8.15
- value
- 6.55
- group Id
- OG001
- lower Limit
- 3.08
- upper Limit
- 6.38
- value
- 4.73
- title
- Physical Functioning Scale at Week 24
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.87
- upper Limit
- 7.04
- value
- 5.46
- group Id
- OG001
- lower Limit
- 2.65
- upper Limit
- 5.97
- value
- 4.31
- title
- Physical Functioning Scale at Week 48
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.85
- upper Limit
- 9.06
- value
- 6.95
- group Id
- OG001
- lower Limit
- 4.14
- upper Limit
- 8.50
- value
- 6.32
- title
- Role Functioning Scale at Week 24
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.61
- upper Limit
- 9.02
- value
- 6.81
- group Id
- OG001
- lower Limit
- 2.69
- upper Limit
- 7.33
- value
- 5.01
- title
- Role Functioning 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. Higher scores in GHS and functional 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 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 and Role Functioning Scores
- type
- SECONDARY
- unit Of Measure
- score on a scale
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Preserved source evidence · Not medical advice