NCT02371369 · OUTCOME
Mean Change From Baseline for Worst Stiffness Numeric Rating Scale Score (NRS) in Participants Receiving Pexidartinib Compared With Those on Placebo Up to Week 25
Phase 3 Study of Pexidartinib for Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS) · Source last updated 2022-05-11
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
- Baseline, Week 9, Week 17, and Week 25
What was measured
The Worst Stiffness Numeric Rating Scale (NRS) was a 1-item, self-administered questionnaire assessing the "worst" stiffness in the last 24 hours. The NRS for this item ranged from 0 (no stiffness) to 10 (stiffness as bad as you can imagine).
Analysis population: Worst stiffness was assessed in the ITT population.
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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Pexidartinib Part 1 | 61 |
|---|
| Placebo Part 1 | 59 |
|---|
Reported measurements
Baseline
Analysis denominator · Participants
| Group | Source count |
|---|
| Pexidartinib Part 1 | 59 |
|---|
| Placebo Part 1 | 58 |
|---|
Values in units on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pexidartinib Part 1 | 5.6 | 0.2 | Not reported | Not reported | Not reported |
|---|
| Placebo Part 1 | 5.9 | 0.3 | Not reported | Not reported | Not reported |
|---|
Week 9
Analysis denominator · Participants
| Group | Source count |
|---|
| Pexidartinib Part 1 | 30 |
|---|
| Placebo Part 1 | 38 |
|---|
Values in units on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pexidartinib Part 1 | -1.5 | 0.3 | Not reported | Not reported | Not reported |
|---|
| Placebo Part 1 | -0.5 | 0.3 | Not reported | Not reported | Not reported |
|---|
Week 17
Analysis denominator · Participants
| Group | Source count |
|---|
| Pexidartinib Part 1 | 37 |
|---|
| Placebo Part 1 | 30 |
|---|
Values in units on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pexidartinib Part 1 | -2.4 | 0.3 | Not reported | Not reported | Not reported |
|---|
| Placebo Part 1 | -0.4 | 0.3 | Not reported | Not reported | Not reported |
|---|
Week 25
Analysis denominator · Participants
| Group | Source count |
|---|
| Pexidartinib Part 1 | 33 |
|---|
| Placebo Part 1 | 35 |
|---|
Values in units on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Pexidartinib Part 1 | -2.5 | 0.3 | Not reported | Not reported | Not reported |
|---|
| Placebo Part 1 | -0.3 | 0.3 | Not reported | Not reported | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- group Description
- Treatment comparison between the pexidartinib and placebo groups at Week 25
- non Inferiority Comment
- Treatment comparison analysis
- non Inferiority Type
- OTHER
- p Value
- <0.0001
- statistical Method
- Mixed effects model for repeated measure
Complete source fields
- analyses
- group Description
- Treatment comparison between the pexidartinib and placebo groups at Week 25
- non Inferiority Comment
- Treatment comparison analysis
- non Inferiority Type
- OTHER
- p Value
- <0.0001
- statistical Method
- Mixed effects model for repeated measure
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.2
- value
- 5.6
- group Id
- OG001
- spread
- 0.3
- value
- 5.9
- denoms
- counts
- group Id
- OG000
- value
- 59
- group Id
- OG001
- value
- 58
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 0.3
- value
- -1.5
- group Id
- OG001
- spread
- 0.3
- value
- -0.5
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 38
- units
- Participants
- title
- Week 9
- categories
- measurements
- group Id
- OG000
- spread
- 0.3
- value
- -2.4
- group Id
- OG001
- spread
- 0.3
- value
- -0.4
- denoms
- counts
- group Id
- OG000
- value
- 37
- group Id
- OG001
- value
- 30
- units
- Participants
- title
- Week 17
- categories
- measurements
- group Id
- OG000
- spread
- 0.3
- value
- -2.5
- group Id
- OG001
- spread
- 0.3
- value
- -0.3
- denoms
- counts
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 35
- units
- Participants
- title
- Week 25
- denoms
- counts
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 59
- units
- Participants
- description
- The Worst Stiffness Numeric Rating Scale (NRS) was a 1-item, self-administered questionnaire assessing the "worst" stiffness in the last 24 hours. The NRS for this item ranged from 0 (no stiffness) to 10 (stiffness as bad as you can imagine).
- 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
- Worst stiffness was assessed in the ITT population.
- reporting Status
- POSTED
- time Frame
- Baseline, Week 9, Week 17, and Week 25
- title
- Mean Change From Baseline for Worst Stiffness Numeric Rating Scale Score (NRS) in Participants Receiving Pexidartinib Compared With Those on Placebo Up to Week 25
- type
- SECONDARY
- unit Of Measure
- units on a scale
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