TriangleNCT02371369 · OUTCOME
Mean Change From Baseline For Range of Motion (ROM) 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
- degrees
- Interval / dispersion
- Standard Error
- Time frame
- Baseline, Week 13, and Week 25
What was measured
Range of motion (ROM) of the joint was assessed by a qualified, independent, and blinded or third-party assessors at the clinical site. Measurements were recorded in degrees. At baseline, the plane of movement with the smallest relative value (worst) was identified and this plane was used for evaluating the relative change of motion subsequently. Only the plane with the worst impaired ROM at baseline was selected for subsequent analyses.
Analysis population: Range of motion 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
Baseline
| Group | Source count |
|---|---|
| Pexidartinib Part 1 | 61 |
| Placebo Part 1 | 58 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pexidartinib Part 1 | 62.5 | 3.2 | Not reported | Not reported | Not reported |
| Placebo Part 1 | 62.9 | 2.9 | Not reported | Not reported | Not reported |
Week 13
| Group | Source count |
|---|---|
| Pexidartinib Part 1 | 52 |
| Placebo Part 1 | 53 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pexidartinib Part 1 | 13.0 | 2.3 | Not reported | Not reported | Not reported |
| Placebo Part 1 | 4.8 | 2.6 | Not reported | Not reported | Not reported |
Week 25
| Group | Source count |
|---|---|
| Pexidartinib Part 1 | 45 |
| Placebo Part 1 | 43 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pexidartinib Part 1 | 15.1 | 2.1 | Not reported | Not reported | Not reported |
| Placebo Part 1 | 6.2 | 2.4 | Not reported | Not reported | Not reported |
Source statistical analyses
- group Description
- Treatment comparison between the pexidartinib and placebo groups at Week 25
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Treatment comparison analysis
- non Inferiority Type
- OTHER
- p Value
- 0.0043
- statistical Method
- Fisher's Exact Test
Complete source fields
- analyses
- group Description
- Treatment comparison between the pexidartinib and placebo groups at Week 25
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Treatment comparison analysis
- non Inferiority Type
- OTHER
- p Value
- 0.0043
- statistical Method
- Fisher's Exact Test
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 3.2
- value
- 62.5
- group Id
- OG001
- spread
- 2.9
- value
- 62.9
- denoms
- counts
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 58
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 2.3
- value
- 13.0
- group Id
- OG001
- spread
- 2.6
- value
- 4.8
- denoms
- counts
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 53
- units
- Participants
- title
- Week 13
- categories
- measurements
- group Id
- OG000
- spread
- 2.1
- value
- 15.1
- group Id
- OG001
- spread
- 2.4
- value
- 6.2
- denoms
- counts
- group Id
- OG000
- value
- 45
- group Id
- OG001
- value
- 43
- units
- Participants
- title
- Week 25
- denoms
- counts
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 59
- units
- Participants
- description
- Range of motion (ROM) of the joint was assessed by a qualified, independent, and blinded or third-party assessors at the clinical site. Measurements were recorded in degrees. At baseline, the plane of movement with the smallest relative value (worst) was identified and this plane was used for evaluating the relative change of motion subsequently. Only the plane with the worst impaired ROM at baseline was selected for subsequent analyses.
- 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
- Range of motion was assessed in the ITT population in participants where data were available.
- reporting Status
- POSTED
- time Frame
- Baseline, Week 13, and Week 25
- title
- Mean Change From Baseline For Range of Motion (ROM) Score in Participants Receiving Pexidartinib Compared With Those on Placebo Up to Week 25
- type
- SECONDARY
- unit Of Measure
- degrees
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice