NCT01154140 · OUTCOME
Change From Baseline Scores in QLQ-C30 Symptoms as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung · Source last updated 2017-11-06
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
- 95% Confidence Interval
- Time frame
- Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)
What was measured
EORTC QLQ-C30: included 5 functional scales (physical, role, cognitive, emotional and social), global health status/global quality of life scale, 3 symptom scales (fatigue, pain, nausea and vomiting), 6 single items that assess the additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea) and financial difficulties. All scales and single-item measures range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, for the global health status/QoL represents a high QoL (better participant state), and for a symptom scale/item represents a high level of symptoms/problems (worse participant state).
Analysis population: The PRO evaluable population included all participants from the FA population who completed a baseline and at least 1 postbaseline PRO assessment prior to crossover to crizotinib or end of randomized study treatment.
Groups in this outcome
Crizotinib
Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
Chemotherapy
Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)\^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m\^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg\*min/mL, approximately 30 min after end of pemetrexed infusion.
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 |
|---|
| Crizotinib | 166 |
|---|
| Chemotherapy | 163 |
|---|
Reported measurements
QLQ-C30 Appetite loss
Values in units on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Crizotinib | -5.4906 | Not reported | -8.52 | -2.47 | Not reported |
|---|
| Chemotherapy | 8.0070 | Not reported | 4.63 | 11.38 | Not reported |
|---|
QLQ-C30 Constipation
Values in units on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Crizotinib | 6.4858 | Not reported | 3.46 | 9.51 | Not reported |
|---|
| Chemotherapy | 10.9194 | Not reported | 7.50 | 14.34 | Not reported |
|---|
QLQ-C30 Diarrhea
Values in units on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Crizotinib | 12.9558 | Not reported | 10.67 | 15.24 | Not reported |
|---|
| Chemotherapy | 0.4652 | Not reported | -2.20 | 3.13 | Not reported |
|---|
QLQ-C30 Dysponea
Values in units on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Crizotinib | -14.9019 | Not reported | -17.40 | -12.40 | Not reported |
|---|
| Chemotherapy | -1.4398 | Not reported | -4.21 | 1.33 | Not reported |
|---|
QLQ-C30 Fatigue
Values in units on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Crizotinib | -7.3476 | Not reported | -9.72 | -4.98 | Not reported |
|---|
| Chemotherapy | 7.6511 | Not reported | 5.05 | 10.25 | Not reported |
|---|
QLQ-C30 Financial Difficulties
Values in units on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Crizotinib | -0.5984 | Not reported | -3.13 | 1.93 | Not reported |
|---|
| Chemotherapy | 0.2203 | Not reported | -2.54 | 2.98 | Not reported |
|---|
QLQ-C30 Insomnia
Values in units on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Crizotinib | -10.3095 | Not reported | -13.10 | -7.52 | Not reported |
|---|
| Chemotherapy | -0.2665 | Not reported | -3.38 | 2.84 | Not reported |
|---|
QLQ-C30 Nausea and Vomiting
Values in units on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Crizotinib | 3.7742 | Not reported | 1.54 | 6.01 | Not reported |
|---|
| Chemotherapy | 7.2188 | Not reported | 4.66 | 9.78 | Not reported |
|---|
QLQ-C30 Pain
Values in units on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Crizotinib | -11.0993 | Not reported | -13.27 | -8.92 | Not reported |
|---|
| Chemotherapy | -1.1716 | Not reported | -3.66 | 1.31 | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- ci Lower Limit
- -18.03
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -8.97
- group Description
- QLQ-C30 appetite loss: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Mean Difference (Net)
- param Value
- -13.4976
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -9.00
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.13
- group Description
- QLQ-C30 constipation: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0570
- param Type
- Mean Difference (Net)
- param Value
- -4.4336
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- 8.98
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 16.00
- group Description
- QLQ-C30 diarrhea: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Mean Difference (Net)
- param Value
- 12.4906
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -17.20
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -9.73
- group Description
- QLQ-C30 dysponea: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Median Difference (Net)
- param Value
- -13.4622
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -18.52
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -11.48
- group Description
- QLQ-C30 fatigue: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Mean Difference (Net)
- param Value
- -14.9987
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -4.56
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.92
- group Description
- QLQ-C30 financial difficulties: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.6681
- param Type
- Mean Difference (Net)
- param Value
- -0.8186
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -14.22
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -5.87
- group Description
- QLQ-C30 insomnia: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Mean Difference (Net)
- param Value
- -10.0430
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -6.84
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -0.05
- group Description
- QLQ-C30 nausea and vomiting: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0468
- param Type
- Mean Difference (Net)
- param Value
- -3.4446
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -13.23
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -6.62
- group Description
- QLQ-C30 pain: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Mean Difference (Net)
- param Value
- -9.9277
- statistical Method
- Mixed Models Analysis
Complete source fields
- analyses
- ci Lower Limit
- -18.03
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -8.97
- group Description
- QLQ-C30 appetite loss: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Mean Difference (Net)
- param Value
- -13.4976
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -9.00
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.13
- group Description
- QLQ-C30 constipation: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0570
- param Type
- Mean Difference (Net)
- param Value
- -4.4336
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- 8.98
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 16.00
- group Description
- QLQ-C30 diarrhea: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Mean Difference (Net)
- param Value
- 12.4906
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -17.20
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -9.73
- group Description
- QLQ-C30 dysponea: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Median Difference (Net)
- param Value
- -13.4622
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -18.52
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -11.48
- group Description
- QLQ-C30 fatigue: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Mean Difference (Net)
- param Value
- -14.9987
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -4.56
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.92
- group Description
- QLQ-C30 financial difficulties: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.6681
- param Type
- Mean Difference (Net)
- param Value
- -0.8186
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -14.22
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -5.87
- group Description
- QLQ-C30 insomnia: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Mean Difference (Net)
- param Value
- -10.0430
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -6.84
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -0.05
- group Description
- QLQ-C30 nausea and vomiting: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0468
- param Type
- Mean Difference (Net)
- param Value
- -3.4446
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- -13.23
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- -6.62
- group Description
- QLQ-C30 pain: Analysis was from a repeated measures mixed-effects model with an intercept term, treatment, treatment-by-time interaction, and baseline EORTC QLQ-C30 subscale baseline score (intercept and time from first dose are included as random effects).
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Mean Difference (Net)
- param Value
- -9.9277
- statistical Method
- Mixed Models Analysis
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -8.52
- upper Limit
- -2.47
- value
- -5.4906
- group Id
- OG001
- lower Limit
- 4.63
- upper Limit
- 11.38
- value
- 8.0070
- title
- QLQ-C30 Appetite loss
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.46
- upper Limit
- 9.51
- value
- 6.4858
- group Id
- OG001
- lower Limit
- 7.50
- upper Limit
- 14.34
- value
- 10.9194
- title
- QLQ-C30 Constipation
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.67
- upper Limit
- 15.24
- value
- 12.9558
- group Id
- OG001
- lower Limit
- -2.20
- upper Limit
- 3.13
- value
- 0.4652
- title
- QLQ-C30 Diarrhea
- categories
- measurements
- group Id
- OG000
- lower Limit
- -17.40
- upper Limit
- -12.40
- value
- -14.9019
- group Id
- OG001
- lower Limit
- -4.21
- upper Limit
- 1.33
- value
- -1.4398
- title
- QLQ-C30 Dysponea
- categories
- measurements
- group Id
- OG000
- lower Limit
- -9.72
- upper Limit
- -4.98
- value
- -7.3476
- group Id
- OG001
- lower Limit
- 5.05
- upper Limit
- 10.25
- value
- 7.6511
- title
- QLQ-C30 Fatigue
- categories
- measurements
- group Id
- OG000
- lower Limit
- -3.13
- upper Limit
- 1.93
- value
- -0.5984
- group Id
- OG001
- lower Limit
- -2.54
- upper Limit
- 2.98
- value
- 0.2203
- title
- QLQ-C30 Financial Difficulties
- categories
- measurements
- group Id
- OG000
- lower Limit
- -13.10
- upper Limit
- -7.52
- value
- -10.3095
- group Id
- OG001
- lower Limit
- -3.38
- upper Limit
- 2.84
- value
- -0.2665
- title
- QLQ-C30 Insomnia
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.54
- upper Limit
- 6.01
- value
- 3.7742
- group Id
- OG001
- lower Limit
- 4.66
- upper Limit
- 9.78
- value
- 7.2188
- title
- QLQ-C30 Nausea and Vomiting
- categories
- measurements
- group Id
- OG000
- lower Limit
- -13.27
- upper Limit
- -8.92
- value
- -11.0993
- group Id
- OG001
- lower Limit
- -3.66
- upper Limit
- 1.31
- value
- -1.1716
- title
- QLQ-C30 Pain
- denoms
- counts
- group Id
- OG000
- value
- 166
- group Id
- OG001
- value
- 163
- units
- Participants
- description
- EORTC QLQ-C30: included 5 functional scales (physical, role, cognitive, emotional and social), global health status/global quality of life scale, 3 symptom scales (fatigue, pain, nausea and vomiting), 6 single items that assess the additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea) and financial difficulties. All scales and single-item measures range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, for the global health status/QoL represents a high QoL (better participant state), and for a symptom scale/item represents a high level of symptoms/problems (worse participant state).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
- id
- OG000
- title
- Crizotinib
- description
- Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)\^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m\^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg\*min/mL, approximately 30 min after end of pemetrexed infusion.
- id
- OG001
- title
- Chemotherapy
- param Type
- MEAN
- population Description
- The PRO evaluable population included all participants from the FA population who completed a baseline and at least 1 postbaseline PRO assessment prior to crossover to crizotinib or end of randomized study treatment.
- reporting Status
- POSTED
- time Frame
- Baseline, From Cycle 1 Day 1 up to end of study treatment or crossover to crizotinib arm (up to 35 months)
- title
- Change From Baseline Scores in QLQ-C30 Symptoms as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)
- type
- SECONDARY
- unit Of Measure
- units on a scale
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