TriangleNCT02371369 · OUTCOME
Mean Change From Baseline For Range of Motion (ROM) Score in Participants Receiving Pexidartinib Compared With Those on Placebo by Week 49
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- degrees
- Interval / dispersion
- Standard Deviation
- Time frame
- By Week 49
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 (ROM) was assessed in the ITT population.
Groups in this outcome
Pexidartinib Part 1 and Part 2
Participants received treatment of Pexidartinib,1000 mg (5 capsules per day) for 2 weeks, then 800 mg (4 capsules per day) for 22 weeks and also received Pexidartinib in Part 2 at their prescribed dose. Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.
Placebo Part 1, Pexidartinib Part 2
Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks in Part 1 and also received Pexidartinib in Part 2 at their prescribed dose. Placebo: Placebo capsule matching Pexidartinib capsule for oral administration Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.
All Pexidartinib Treated
All participants who received Pexidartinib in Part 1 and Part 2 as well as those who only received Pexidartinib in Part 2.
| Group | Source count |
|---|---|
| Pexidartinib Part 1 and Part 2 | 61 |
| Placebo Part 1, Pexidartinib Part 2 | 30 |
| All Pexidartinib Treated | 91 |
Reported measurements
Baseline
| Group | Source count |
|---|---|
| Pexidartinib Part 1 and Part 2 | 61 |
| Placebo Part 1, Pexidartinib Part 2 | 30 |
| All Pexidartinib Treated | 91 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pexidartinib Part 1 and Part 2 | 62.5 | 24.8 | Not reported | Not reported | Not reported |
| Placebo Part 1, Pexidartinib Part 2 | 66.5 | 22.9 | Not reported | Not reported | Not reported |
| All Pexidartinib Treated | 63.8 | 24.2 | Not reported | Not reported | Not reported |
Week 25
| Group | Source count |
|---|---|
| Pexidartinib Part 1 and Part 2 | 45 |
| Placebo Part 1, Pexidartinib Part 2 | 24 |
| All Pexidartinib Treated | 69 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pexidartinib Part 1 and Part 2 | 15.6 | 14.9 | Not reported | Not reported | Not reported |
| Placebo Part 1, Pexidartinib Part 2 | 13.1 | 12.9 | Not reported | Not reported | Not reported |
| All Pexidartinib Treated | 14.8 | 14.2 | Not reported | Not reported | Not reported |
Week 49
| Group | Source count |
|---|---|
| Pexidartinib Part 1 and Part 2 | 33 |
| Placebo Part 1, Pexidartinib Part 2 | 22 |
| All Pexidartinib Treated | 55 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pexidartinib Part 1 and Part 2 | 14.4 | 19.5 | Not reported | Not reported | Not reported |
| Placebo Part 1, Pexidartinib Part 2 | 12.0 | 13.4 | Not reported | Not reported | Not reported |
| All Pexidartinib Treated | 13.4 | 17.3 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 24.8
- value
- 62.5
- group Id
- OG001
- spread
- 22.9
- value
- 66.5
- group Id
- OG002
- spread
- 24.2
- value
- 63.8
- denoms
- counts
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 30
- group Id
- OG002
- value
- 91
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 14.9
- value
- 15.6
- group Id
- OG001
- spread
- 12.9
- value
- 13.1
- group Id
- OG002
- spread
- 14.2
- value
- 14.8
- denoms
- counts
- group Id
- OG000
- value
- 45
- group Id
- OG001
- value
- 24
- group Id
- OG002
- value
- 69
- units
- Participants
- title
- Week 25
- categories
- measurements
- group Id
- OG000
- spread
- 19.5
- value
- 14.4
- group Id
- OG001
- spread
- 13.4
- value
- 12.0
- group Id
- OG002
- spread
- 17.3
- value
- 13.4
- denoms
- counts
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 22
- group Id
- OG002
- value
- 55
- units
- Participants
- title
- Week 49
- denoms
- counts
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 30
- group Id
- OG002
- value
- 91
- 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 Deviation
- 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 and also received Pexidartinib in Part 2 at their prescribed dose. Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.
- id
- OG000
- title
- Pexidartinib Part 1 and Part 2
- description
- Participants received treatment of matching placebo (5 capsules per day) for 2 weeks, then matching placebo (4 capsules per day) for 22 weeks in Part 1 and also received Pexidartinib in Part 2 at their prescribed dose. Placebo: Placebo capsule matching Pexidartinib capsule for oral administration Pexidartinib: Each capsule contains 200 mg of Pexidartinib for oral administration.
- id
- OG001
- title
- Placebo Part 1, Pexidartinib Part 2
- description
- All participants who received Pexidartinib in Part 1 and Part 2 as well as those who only received Pexidartinib in Part 2.
- id
- OG002
- title
- All Pexidartinib Treated
- param Type
- MEAN
- population Description
- Range of Motion (ROM) was assessed in the ITT population.
- reporting Status
- POSTED
- time Frame
- By Week 49
- title
- Mean Change From Baseline For Range of Motion (ROM) Score in Participants Receiving Pexidartinib Compared With Those on Placebo by Week 49
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- degrees
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice