TriangleNCT01740427 · OUTCOME
Change From Baseline Between Treatment Comparison in Functional Assessment of Cancer Therapy-Breast (FACT-B)
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 Baseline up to 2.5 years
What was measured
FACT is a modular approach to assess participant health-related quality of life using a 'core' set of questions (FACT-G) as well as a cancer site-specific module. The FACT-G is a 27-item compilation of general questions divided into 4 domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. The FACT-B consisted of the FACT-G (27-item) and a breast-specific module: a 10-item instrument designed to assess participant concerns relating to breast cancer. For all questions, participants were asked to respond to a five-level scale where 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. FACT-B total score = Physical Well-Being + Social/Family Well-Being + Emotional Well-Being + Functional Well-Being + Breast Cancer Subscale. As each of the items ranges from 0-4, the range of possible scores is 0-144, with 0 being the worst possible score and 144 the best.
Analysis population: Patient Reported Outcome (PRO) Analysis Set is a subset of ITT participants, who had both baseline and at least one follow-up PRO assessment.
Groups in this outcome
Palbociclib Plus Letrozole
Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
Placebo Plus Letrozole
Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
| Group | Source count |
|---|---|
| Palbociclib Plus Letrozole | 439 |
| Placebo Plus Letrozole | 218 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Palbociclib Plus Letrozole | -0.106 | Not reported | -1.42 | 1.21 | Not reported |
| Placebo Plus Letrozole | 0.219 | Not reported | -1.68 | 2.12 | Not reported |
Source statistical analyses
- ci Lower Limit
- -2.63
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.98
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.7822
- param Type
- Mean Difference (Final Values)
- param Value
- -0.325
- 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 Models Analysis
Complete source fields
- analyses
- ci Lower Limit
- -2.63
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.98
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.7822
- param Type
- Mean Difference (Final Values)
- param Value
- -0.325
- 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 Models Analysis
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -1.42
- upper Limit
- 1.21
- value
- -0.106
- group Id
- OG001
- lower Limit
- -1.68
- upper Limit
- 2.12
- value
- 0.219
- denoms
- counts
- group Id
- OG000
- value
- 439
- group Id
- OG001
- value
- 218
- units
- Participants
- description
- FACT is a modular approach to assess participant health-related quality of life using a 'core' set of questions (FACT-G) as well as a cancer site-specific module. The FACT-G is a 27-item compilation of general questions divided into 4 domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. The FACT-B consisted of the FACT-G (27-item) and a breast-specific module: a 10-item instrument designed to assess participant concerns relating to breast cancer. For all questions, participants were asked to respond to a five-level scale where 0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, and 4=very much. FACT-B total score = Physical Well-Being + Social/Family Well-Being + Emotional Well-Being + Functional Well-Being + Breast Cancer Subscale. As each of the items ranges from 0-4, the range of possible scores is 0-144, with 0 being the worst possible score and 144 the best.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
- id
- OG000
- title
- Palbociclib Plus Letrozole
- description
- Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
- id
- OG001
- title
- Placebo Plus Letrozole
- param Type
- MEAN
- population Description
- Patient Reported Outcome (PRO) Analysis Set is a subset of ITT participants, who had both baseline and at least one follow-up PRO assessment.
- reporting Status
- POSTED
- time Frame
- From Baseline up to 2.5 years
- title
- Change From Baseline Between Treatment Comparison in Functional Assessment of Cancer Therapy-Breast (FACT-B)
- type
- SECONDARY
- unit Of Measure
- Units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice