TriangleNCT02107703 · OUTCOME
Change From Baseline in Health Status Using the EuroQol 5-Dimension 5 Level (EQ-5D 5L)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- mm
- Interval / dispersion
- Standard Error
- Time frame
- Baseline, End of Study (Up To 31 Months)
What was measured
European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The EQ-5D-5L is assessed using a visual analog scale (VAS) that ranged from 0 to 100mm, where 0 is the worst health you can imagine and 100 is the best health you can imagine. A higher score indicates better health state. LS Mean value was controlled for Treatment, visit, Treatment\*Visit and baseline.
Analysis population: All randomized participants who received at least one dose of study drug with baseline and post-baseline EQ-5D 5L data.
Groups in this outcome
Abemaciclib + Fulvestrant
Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
Placebo + Fulvestrant
Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
| Group | Source count |
|---|---|
| Abemaciclib + Fulvestrant | 441 |
| Placebo + Fulvestrant | 223 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Abemaciclib + Fulvestrant | 0.12 | 0.65 | Not reported | Not reported | Not reported |
| Placebo + Fulvestrant | 1.16 | 0.92 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.65
- value
- 0.12
- group Id
- OG001
- spread
- 0.92
- value
- 1.16
- denoms
- counts
- group Id
- OG000
- value
- 441
- group Id
- OG001
- value
- 223
- units
- Participants
- description
- European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The EQ-5D-5L is assessed using a visual analog scale (VAS) that ranged from 0 to 100mm, where 0 is the worst health you can imagine and 100 is the best health you can imagine. A higher score indicates better health state. LS Mean value was controlled for Treatment, visit, Treatment\*Visit and baseline.
- dispersion Type
- Standard Error
- groups
- description
- Abemaciclib 150 mg administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
- id
- OG000
- title
- Abemaciclib + Fulvestrant
- description
- Placebo administered orally every 12 hours on Days 1 to 28 of a 28-day cycle in combination with fulvestrant 500mg administered IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants received treatment until discontinuation were met.
- id
- OG001
- title
- Placebo + Fulvestrant
- param Type
- LEAST_SQUARES_MEAN
- population Description
- All randomized participants who received at least one dose of study drug with baseline and post-baseline EQ-5D 5L data.
- reporting Status
- POSTED
- time Frame
- Baseline, End of Study (Up To 31 Months)
- title
- Change From Baseline in Health Status Using the EuroQol 5-Dimension 5 Level (EQ-5D 5L)
- type
- SECONDARY
- unit Of Measure
- mm
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice