TriangleNCT02371369 · OUTCOME
Mean Change From Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function Score in Participants Receiving Pexidartinib Compared With Those on Placebo Up to Week 25
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
- at Week 9 , Week 17, and Week 25
What was measured
The Patient-reported Outcomes Measurement Information System (PROMIS) physical function scale was used to assess physical function of the upper and lower limbs. The scale ranged from 1 defined as 'unable to do' or 'cannot do' to 5 defined as 'without any difficulty' or 'not at all', where higher scores represent better outcomes.
Analysis population: Physical function was assessed in the ITT population in participants where data were available.
Groups in this outcome
Pexidartinib Part 1
Participants received treatment of Pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.
Placebo Part 1
Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks Placebo: Placebo capsule matching Pexidartinib capsule for oral administration.
| Group | Source count |
|---|---|
| Pexidartinib Part 1 | 61 |
| Placebo Part 1 | 59 |
Reported measurements
Week 9
| Group | Source count |
|---|---|
| Pexidartinib Part 1 | 38 |
| Placebo Part 1 | 41 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pexidartinib Part 1 | 2.8 | 1.0 | Not reported | Not reported | Not reported |
| Placebo Part 1 | -0.4 | 0.8 | Not reported | Not reported | Not reported |
Week 17
| Group | Source count |
|---|---|
| Pexidartinib Part 1 | 39 |
| Placebo Part 1 | 40 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pexidartinib Part 1 | 3.2 | 1.1 | Not reported | Not reported | Not reported |
| Placebo Part 1 | 0.2 | 1.0 | Not reported | Not reported | Not reported |
Week 25
| Group | Source count |
|---|---|
| Pexidartinib Part 1 | 38 |
| Placebo Part 1 | 31 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pexidartinib Part 1 | 4.1 | 1.1 | Not reported | Not reported | Not reported |
| Placebo Part 1 | -0.9 | 1.0 | Not reported | Not reported | Not reported |
Source statistical analyses
- group Description
- Treatment comparison between pexidartinib and placebo groups at Week 25
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Treatment comparison analysis
- non Inferiority Type
- OTHER
- p Value
- 0.0019
- statistical Method
- Mixed effects model for repeated measure
Complete source fields
- analyses
- group Description
- Treatment comparison between pexidartinib and placebo groups at Week 25
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Treatment comparison analysis
- non Inferiority Type
- OTHER
- p Value
- 0.0019
- statistical Method
- Mixed effects model for repeated measure
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.0
- value
- 2.8
- group Id
- OG001
- spread
- 0.8
- value
- -0.4
- denoms
- counts
- group Id
- OG000
- value
- 38
- group Id
- OG001
- value
- 41
- units
- Participants
- title
- Week 9
- categories
- measurements
- group Id
- OG000
- spread
- 1.1
- value
- 3.2
- group Id
- OG001
- spread
- 1.0
- value
- 0.2
- denoms
- counts
- group Id
- OG000
- value
- 39
- group Id
- OG001
- value
- 40
- units
- Participants
- title
- Week 17
- categories
- measurements
- group Id
- OG000
- spread
- 1.1
- value
- 4.1
- group Id
- OG001
- spread
- 1.0
- value
- -0.9
- denoms
- counts
- group Id
- OG000
- value
- 38
- group Id
- OG001
- value
- 31
- units
- Participants
- title
- Week 25
- denoms
- counts
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 59
- units
- Participants
- description
- The Patient-reported Outcomes Measurement Information System (PROMIS) physical function scale was used to assess physical function of the upper and lower limbs. The scale ranged from 1 defined as 'unable to do' or 'cannot do' to 5 defined as 'without any difficulty' or 'not at all', where higher scores represent better outcomes.
- dispersion Type
- Standard Error
- groups
- description
- Participants received treatment of Pexidartinib,1000 mg (5 capsules per day ) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.
- id
- OG000
- title
- Pexidartinib Part 1
- description
- Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks Placebo: Placebo capsule matching Pexidartinib capsule for oral administration.
- id
- OG001
- title
- Placebo Part 1
- param Type
- LEAST_SQUARES_MEAN
- population Description
- Physical function was assessed in the ITT population in participants where data were available.
- reporting Status
- POSTED
- time Frame
- at Week 9 , Week 17, and Week 25
- title
- Mean Change From Baseline in the Patient-reported Outcomes Measurement Information System (PROMIS) Physical Function Score in Participants Receiving Pexidartinib Compared With Those on Placebo Up to Week 25
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice