TriangleNCT01740427 · OUTCOME
Change From Baseline Between Treatment Comparison in Euro Quality of Life (EQ-5D) Index
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
The EuroQol EQ-5D is a 6-item instrument designed to assess health status in terms of a single index value or utility score. It contains 5 descriptors of current health state (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with each dimension having 3 levels of function (1=no problem, 2=some problem, and 3=extreme problem). The scores on the 5 descriptors are summarized to create a single summary score. An overall utility score is calculated based on these domains, with a range score from 0 (worse health scenario) to a maximum of 1.0 (best health scenario).
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 | 437 |
| Placebo Plus Letrozole | 218 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Palbociclib Plus Letrozole | 0.014 | Not reported | 0.00 | 0.03 | Not reported |
| Placebo Plus Letrozole | -0.010 | Not reported | -0.03 | 0.01 | Not reported |
Source statistical analyses
- ci Lower Limit
- -0.004
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.051
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0925
- param Type
- Mean Difference (Final Values)
- param Value
- 0.023
- 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
- -0.004
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.051
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- p Value
- 0.0925
- param Type
- Mean Difference (Final Values)
- param Value
- 0.023
- 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
- 0.00
- upper Limit
- 0.03
- value
- 0.014
- group Id
- OG001
- lower Limit
- -0.03
- upper Limit
- 0.01
- value
- -0.010
- denoms
- counts
- group Id
- OG000
- value
- 437
- group Id
- OG001
- value
- 218
- units
- Participants
- description
- The EuroQol EQ-5D is a 6-item instrument designed to assess health status in terms of a single index value or utility score. It contains 5 descriptors of current health state (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with each dimension having 3 levels of function (1=no problem, 2=some problem, and 3=extreme problem). The scores on the 5 descriptors are summarized to create a single summary score. An overall utility score is calculated based on these domains, with a range score from 0 (worse health scenario) to a maximum of 1.0 (best health scenario).
- 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 Euro Quality of Life (EQ-5D) Index
- type
- SECONDARY
- unit Of Measure
- Units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice