TriangleNCT02107703 · OUTCOME
Change From Baseline in Pain and Symptom Burden Assessment Using the Modified Brief Pain Inventory-Short Form (mBPI-sf)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- score on a scale
- Interval / dispersion
- Standard Error
- Time frame
- Baseline, End of Study (Up To 31 Months)
What was measured
A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The overall change is based on the estimated main treatment effect. Least square (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 a baseline and at least 1 post-baseline result.
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 | -0.06 | 0.07 | Not reported | Not reported | Not reported |
| Placebo + Fulvestrant | 0.00 | 0.10 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.07
- value
- -0.06
- group Id
- OG001
- spread
- 0.10
- value
- 0.00
- denoms
- counts
- group Id
- OG000
- value
- 441
- group Id
- OG001
- value
- 223
- units
- Participants
- description
- A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The overall change is based on the estimated main treatment effect. Least square (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 a baseline and at least 1 post-baseline result.
- reporting Status
- POSTED
- time Frame
- Baseline, End of Study (Up To 31 Months)
- title
- Change From Baseline in Pain and Symptom Burden Assessment Using the Modified Brief Pain Inventory-Short Form (mBPI-sf)
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice