TriangleNCT01942135 · OUTCOME
Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scale Scores
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
- From Cycle 1 to 14, as of 05 December 2014.
What was measured
The EORTC-QLQ-C30 is a 30-item questionnaire composed of five multi-item functional subscales (physical, role, emotional, cognitive , and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global quality of life (QOL) subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The questionnaire employs 28 4-point Likert scales with responses from "not at all" to "very much" and two 7-point Likert scales for global health and overall QOL. Responses to all items are then converted to a 0 to 100 scale. For functional and global QOL scales, higher scores represent a better level of functioning/QOL. For symptom-oriented scales, a higher score represents more severe symptoms. A 10-point or higher change in scores from baseline is considered clinically significant.
Analysis population: The PRO -evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post -baseline PRO assessment prior to end of study treatment. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.
Groups in this outcome
Palbociclib + Fulvestrant
Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 105 cycles.
Placebo + Fulvestrant
Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 93 cycles.
| Group | Source count |
|---|---|
| Palbociclib + Fulvestrant | 335 |
| Placebo + Fulvestrant | 166 |
Reported measurements
Global health status / QoL
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Palbociclib + Fulvestrant | -0.9 | 64.5 | -2.5 | 0.7 | Not reported |
| Placebo + Fulvestrant | -4.0 | 26.25 | -6.3 | -1.7 | Not reported |
Physical functioning
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Palbociclib + Fulvestrant | -0.7 | 22.76 | -2.1 | 0.7 | Not reported |
| Placebo + Fulvestrant | -1.7 | 21.24 | -3.7 | 0.2 | Not reported |
Role functioning
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Palbociclib + Fulvestrant | -1.8 | 30.70 | -3.7 | 0.1 | Not reported |
| Placebo + Fulvestrant | -3.7 | 28.04 | -6.5 | -0.9 | Not reported |
Emotional functioning
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Palbociclib + Fulvestrant | 2.7 | 25.97 | 1.1 | 4.3 | Not reported |
| Placebo + Fulvestrant | -1.9 | 21.19 | -4.2 | 0.5 | Not reported |
Cognitive functioning
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Palbociclib + Fulvestrant | -1.7 | 20.97 | -3.1 | -0.2 | Not reported |
| Placebo + Fulvestrant | -2.9 | 20.22 | -5.0 | -0.7 | Not reported |
Social functioning
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Palbociclib + Fulvestrant | -0.5 | 32.07 | -2.5 | 1.5 | Not reported |
| Placebo + Fulvestrant | -0.6 | 32.27 | -3.4 | 2.3 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.3
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 6.0
- group Description
- Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for Global health status/ QoL
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0313
- p Value Comment
- The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.
- param Type
- Mean Difference (Final Values)
- param Value
- 3.1
- statistical Comment
- Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.
- statistical Method
- Mixed Model Analysis (2-sided)
- ci Lower Limit
- -1.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.5
- group Description
- Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for physical functioning
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.4000
- p Value Comment
- The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.
- param Type
- Mean Difference (Final Values)
- param Value
- 1.0
- statistical Comment
- Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.
- statistical Method
- Mixed Model Analysis (2-sided)
- ci Lower Limit
- -1.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.3
- group Description
- Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for role functioning
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.2615
- p Value Comment
- The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.
- param Type
- Mean Difference (Final Values)
- param Value
- 1.9
- statistical Comment
- Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.
- statistical Method
- Mixed Model Analysis (2-sided)
- ci Lower Limit
- 1.7
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 7.4
- group Description
- Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for emotional functioning
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0016
- p Value Comment
- The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.
- param Type
- Mean Difference (Final Values)
- param Value
- 4.6
- statistical Comment
- Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.
- statistical Method
- Mixed Model Analysis (2-sided)
- ci Lower Limit
- -1.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.8
- group Description
- Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for cognitive functioning
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.3650
- p Value Comment
- The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.
- param Type
- Mean Difference (Final Values)
- param Value
- 1.2
- statistical Comment
- Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.
- statistical Method
- Mixed Model Analysis (2-sided)
- ci Lower Limit
- -3.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.5
- group Description
- Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for social functioning
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.9615
- p Value Comment
- The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.
- param Type
- Mean Difference (Final Values)
- param Value
- 0.1
- statistical Comment
- Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.
- statistical Method
- Mixed Model Analysis (2-sided)
Complete source fields
- analyses
- ci Lower Limit
- 0.3
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 6.0
- group Description
- Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for Global health status/ QoL
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0313
- p Value Comment
- The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.
- param Type
- Mean Difference (Final Values)
- param Value
- 3.1
- statistical Comment
- Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.
- statistical Method
- Mixed Model Analysis (2-sided)
- ci Lower Limit
- -1.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.5
- group Description
- Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for physical functioning
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.4000
- p Value Comment
- The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.
- param Type
- Mean Difference (Final Values)
- param Value
- 1.0
- statistical Comment
- Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.
- statistical Method
- Mixed Model Analysis (2-sided)
- ci Lower Limit
- -1.5
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.3
- group Description
- Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for role functioning
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.2615
- p Value Comment
- The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.
- param Type
- Mean Difference (Final Values)
- param Value
- 1.9
- statistical Comment
- Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.
- statistical Method
- Mixed Model Analysis (2-sided)
- ci Lower Limit
- 1.7
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 7.4
- group Description
- Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for emotional functioning
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0016
- p Value Comment
- The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.
- param Type
- Mean Difference (Final Values)
- param Value
- 4.6
- statistical Comment
- Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.
- statistical Method
- Mixed Model Analysis (2-sided)
- ci Lower Limit
- -1.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.8
- group Description
- Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for cognitive functioning
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.3650
- p Value Comment
- The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.
- param Type
- Mean Difference (Final Values)
- param Value
- 1.2
- statistical Comment
- Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.
- statistical Method
- Mixed Model Analysis (2-sided)
- ci Lower Limit
- -3.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.5
- group Description
- Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for social functioning
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.9615
- p Value Comment
- The priori threshold for statistical significance is 2-sided alpha=0.05. The p-value was not adjusted for multiple comparisons.
- param Type
- Mean Difference (Final Values)
- param Value
- 0.1
- statistical Comment
- Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.
- statistical Method
- Mixed Model Analysis (2-sided)
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -2.5
- spread
- 64.5
- upper Limit
- 0.7
- value
- -0.9
- group Id
- OG001
- lower Limit
- -6.3
- spread
- 26.25
- upper Limit
- -1.7
- value
- -4.0
- title
- Global health status / QoL
- categories
- measurements
- group Id
- OG000
- lower Limit
- -2.1
- spread
- 22.76
- upper Limit
- 0.7
- value
- -0.7
- group Id
- OG001
- lower Limit
- -3.7
- spread
- 21.24
- upper Limit
- 0.2
- value
- -1.7
- title
- Physical functioning
- categories
- measurements
- group Id
- OG000
- lower Limit
- -3.7
- spread
- 30.70
- upper Limit
- 0.1
- value
- -1.8
- group Id
- OG001
- lower Limit
- -6.5
- spread
- 28.04
- upper Limit
- -0.9
- value
- -3.7
- title
- Role functioning
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.1
- spread
- 25.97
- upper Limit
- 4.3
- value
- 2.7
- group Id
- OG001
- lower Limit
- -4.2
- spread
- 21.19
- upper Limit
- 0.5
- value
- -1.9
- title
- Emotional functioning
- categories
- measurements
- group Id
- OG000
- lower Limit
- -3.1
- spread
- 20.97
- upper Limit
- -0.2
- value
- -1.7
- group Id
- OG001
- lower Limit
- -5.0
- spread
- 20.22
- upper Limit
- -0.7
- value
- -2.9
- title
- Cognitive functioning
- categories
- measurements
- group Id
- OG000
- lower Limit
- -2.5
- spread
- 32.07
- upper Limit
- 1.5
- value
- -0.5
- group Id
- OG001
- lower Limit
- -3.4
- spread
- 32.27
- upper Limit
- 2.3
- value
- -0.6
- title
- Social functioning
- denoms
- counts
- group Id
- OG000
- value
- 335
- group Id
- OG001
- value
- 166
- units
- Participants
- description
- The EORTC-QLQ-C30 is a 30-item questionnaire composed of five multi-item functional subscales (physical, role, emotional, cognitive , and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global quality of life (QOL) subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The questionnaire employs 28 4-point Likert scales with responses from "not at all" to "very much" and two 7-point Likert scales for global health and overall QOL. Responses to all items are then converted to a 0 to 100 scale. For functional and global QOL scales, higher scores represent a better level of functioning/QOL. For symptom-oriented scales, a higher score represents more severe symptoms. A 10-point or higher change in scores from baseline is considered clinically significant.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 105 cycles.
- id
- OG000
- title
- Palbociclib + Fulvestrant
- description
- Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase. Maximum treatment duration was 93 cycles.
- id
- OG001
- title
- Placebo + Fulvestrant
- param Type
- MEAN
- population Description
- The PRO -evaluable population is defined as a subset of ITT participants, who have completed a baseline and at least one post -baseline PRO assessment prior to end of study treatment. Analysis based on repeated measures mixed-effects model with an intercept term, treatment, time, treatment-by-time, and baseline as covariate.
- reporting Status
- POSTED
- time Frame
- From Cycle 1 to 14, as of 05 December 2014.
- title
- Change From Baseline Between Treatment Comparison in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scale Scores
- type
- SECONDARY
- unit Of Measure
- Units on a scale
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Preserved source evidence · Not medical advice