TriangleNCT01942135 · OUTCOME
Change From Baseline Between Treatment Comparison in EORTC QLQ BR23 Symptom 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-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss). QLQ-BR23 questionnaire employs 4-point scales with responses from 'not at all' to 'very much'. All scores are converted to a 0 to 100 scale. For symptom-oriented scales, a higher score represent more severe symptoms.
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
Systemic therapy side effects
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Palbociclib + Fulvestrant | 3.8 | 15.19 | 2.6 | 4.9 | Not reported |
| Placebo + Fulvestrant | 3.4 | 14.31 | 1.8 | 5.0 | Not reported |
Breast symptoms
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Palbociclib + Fulvestrant | -2.2 | 21.32 | -3.2 | -1.3 | Not reported |
| Placebo + Fulvestrant | -1.3 | 17.49 | -2.7 | 0.0 | Not reported |
Arm symptoms
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Palbociclib + Fulvestrant | -2.2 | 20.59 | -3.6 | -0.9 | Not reported |
| Placebo + Fulvestrant | -2.0 | 20.08 | -4.0 | -0.1 | Not reported |
Upset by hair loss
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Palbociclib + Fulvestrant | 2.9 | 30.19 | -1.7 | 7.4 | Not reported |
| Placebo + Fulvestrant | -6.0 | 20.91 | -12.3 | 0.3 | Not reported |
Source statistical analyses
- ci Lower Limit
- -1.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.3
- group Description
- Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for systemic therapy side effects
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.7273
- 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
- 0.4
- 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
- -2.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.7
- group Description
- Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for breast symptoms
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.2671
- 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
- -0.9
- 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
- -2.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.2
- group Description
- Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for arm symptoms
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.8750
- 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
- -0.2
- 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
- 1.1
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 16.6
- group Description
- Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for upset by hair loss
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0255
- 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
- 8.9
- 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)
Complete source fields
- analyses
- ci Lower Limit
- -1.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.3
- group Description
- Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for systemic therapy side effects
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.7273
- 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
- 0.4
- 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
- -2.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.7
- group Description
- Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for breast symptoms
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.2671
- 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
- -0.9
- 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
- -2.6
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 2.2
- group Description
- Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for arm symptoms
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.8750
- 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
- -0.2
- 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
- 1.1
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 16.6
- group Description
- Statistical significance for palbociclib plus fulvestrant vs placebo plus fulvestrant for upset by hair loss
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0255
- 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
- 8.9
- 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)
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.6
- spread
- 15.19
- upper Limit
- 4.9
- value
- 3.8
- group Id
- OG001
- lower Limit
- 1.8
- spread
- 14.31
- upper Limit
- 5.0
- value
- 3.4
- title
- Systemic therapy side effects
- categories
- measurements
- group Id
- OG000
- lower Limit
- -3.2
- spread
- 21.32
- upper Limit
- -1.3
- value
- -2.2
- group Id
- OG001
- lower Limit
- -2.7
- spread
- 17.49
- upper Limit
- 0.0
- value
- -1.3
- title
- Breast symptoms
- categories
- measurements
- group Id
- OG000
- lower Limit
- -3.6
- spread
- 20.59
- upper Limit
- -0.9
- value
- -2.2
- group Id
- OG001
- lower Limit
- -4.0
- spread
- 20.08
- upper Limit
- -0.1
- value
- -2.0
- title
- Arm symptoms
- categories
- measurements
- group Id
- OG000
- lower Limit
- -1.7
- spread
- 30.19
- upper Limit
- 7.4
- value
- 2.9
- group Id
- OG001
- lower Limit
- -12.3
- spread
- 20.91
- upper Limit
- 0.3
- value
- -6.0
- title
- Upset by hair loss
- denoms
- counts
- group Id
- OG000
- value
- 335
- group Id
- OG001
- value
- 166
- units
- Participants
- description
- The EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of four functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and four symptom scales (systemic side effects, breast symptoms, arm symptoms, upset by hair loss). QLQ-BR23 questionnaire employs 4-point scales with responses from 'not at all' to 'very much'. All scores are converted to a 0 to 100 scale. For symptom-oriented scales, a higher score represent more severe symptoms.
- 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 EORTC QLQ BR23 Symptom Scale Scores
- type
- SECONDARY
- unit Of Measure
- Units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice