TriangleNCT02246621 · OUTCOME
Change From Baseline to End of Study in Health Status on the EuroQuol 5-Dimension 5 Level (EuroQol-5D 5L) Index Value
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Error
- Time frame
- Baseline, End of Study (Up to 32 Months)
What was measured
The EuroQol-5D (version 5L) is a brief self-administered, validated instrument consisting of 2 parts.The first part consists of 5 descriptors of current health state (mobility, self care, usual activities, pain/discomfort, and anxiety/ depression); a participant is asked to rate each state on a five level scale (no problem, slight problem, moderate problem, severe problem and extreme problem) with higher levels indicating greater severity/ impairment. Published weights are available that allow for the creation of a single summary score called the EQ-5D index that ranges from 0 to 1, with low scores representing a higher level of dysfunction and 1 as perfect health. Minimally important differences in the EQ-5D index score are 0.06 or greater in cancer patients. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, Visit, Treatment\*Visit and Baseline.
Analysis population: All randomized participants.
Groups in this outcome
Abemaciclib + NSAI
150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Placebo + NSAI
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
| Group | Source count |
|---|---|
| Abemaciclib + NSAI | 328 |
| Placebo + NSAI | 165 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Abemaciclib + NSAI | 0.01 | 0.01 | Not reported | Not reported | Not reported |
| Placebo + NSAI | 0.01 | 0.01 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Num Sides
- TWO_SIDED
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.02
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.688
- param Type
- Mean Difference (Net)
- param Value
- -0.01
- statistical Method
- Mixed Models Analysis
Complete source fields
- analyses
- ci Num Sides
- TWO_SIDED
- dispersion Type
- STANDARD_ERROR_OF_MEAN
- dispersion Value
- 0.02
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.688
- param Type
- Mean Difference (Net)
- param Value
- -0.01
- statistical Method
- Mixed Models Analysis
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.01
- value
- 0.01
- group Id
- OG001
- spread
- 0.01
- value
- 0.01
- denoms
- counts
- group Id
- OG000
- value
- 328
- group Id
- OG001
- value
- 165
- units
- Participants
- description
- The EuroQol-5D (version 5L) is a brief self-administered, validated instrument consisting of 2 parts.The first part consists of 5 descriptors of current health state (mobility, self care, usual activities, pain/discomfort, and anxiety/ depression); a participant is asked to rate each state on a five level scale (no problem, slight problem, moderate problem, severe problem and extreme problem) with higher levels indicating greater severity/ impairment. Published weights are available that allow for the creation of a single summary score called the EQ-5D index that ranges from 0 to 1, with low scores representing a higher level of dysfunction and 1 as perfect health. Minimally important differences in the EQ-5D index score are 0.06 or greater in cancer patients. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, Visit, Treatment\*Visit and Baseline.
- dispersion Type
- Standard Error
- groups
- description
- 150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
- id
- OG000
- title
- Abemaciclib + NSAI
- description
- Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
- id
- OG001
- title
- Placebo + NSAI
- param Type
- LEAST_SQUARES_MEAN
- population Description
- All randomized participants.
- reporting Status
- POSTED
- time Frame
- Baseline, End of Study (Up to 32 Months)
- title
- Change From Baseline to End of Study in Health Status on the EuroQuol 5-Dimension 5 Level (EuroQol-5D 5L) Index Value
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice