TriangleNCT02371369 · OUTCOME
Mean Change From Baseline for Worst Pain Numeric Rating Scale Score (NRS) 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
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- By Week 49
What was measured
The Brief Pain Inventory (BPI) Worst Pain NRS was a 1-item, self-administered questionnaire assessing the "worst" pain in the last 24 hours. The NRS for this item ranged from 0 (no pain) to 10 (pain as bad as you can imagine).
Analysis population: Worst pain was assessed in the ITT population, specifically among the Pexidartinib Part 1, Pexidartinib Part 2; Placebo Part 1, Pexidartinib Part 2; and All Pexidartinib Treated participants. Participants who received Placebo Part 1 only or Pexidartinib Part 2 only were not analyzed.
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 | 59 |
| Placebo Part 1, Pexidartinib Part 2 | 26 |
| All Pexidartinib Treated | 85 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pexidartinib Part 1 and Part 2 | 5.6 | 1.6 | Not reported | Not reported | Not reported |
| Placebo Part 1, Pexidartinib Part 2 | 5.2 | 2.5 | Not reported | Not reported | Not reported |
| All Pexidartinib Treated | 5.5 | 1.9 | Not reported | Not reported | Not reported |
Week 25
| Group | Source count |
|---|---|
| Pexidartinib Part 1 and Part 2 | 33 |
| Placebo Part 1, Pexidartinib Part 2 | 18 |
| All Pexidartinib Treated | 51 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pexidartinib Part 1 and Part 2 | -2.7 | 2.2 | Not reported | Not reported | Not reported |
| Placebo Part 1, Pexidartinib Part 2 | -2.6 | 3.1 | Not reported | Not reported | Not reported |
| All Pexidartinib Treated | -2.7 | 2.5 | Not reported | Not reported | Not reported |
Week 49
| Group | Source count |
|---|---|
| Pexidartinib Part 1 and Part 2 | 22 |
| Placebo Part 1, Pexidartinib Part 2 | 10 |
| All Pexidartinib Treated | 32 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pexidartinib Part 1 and Part 2 | -3.3 | 1.7 | Not reported | Not reported | Not reported |
| Placebo Part 1, Pexidartinib Part 2 | -2.8 | 3.4 | Not reported | Not reported | Not reported |
| All Pexidartinib Treated | -3.2 | 2.3 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.6
- value
- 5.6
- group Id
- OG001
- spread
- 2.5
- value
- 5.2
- group Id
- OG002
- spread
- 1.9
- value
- 5.5
- denoms
- counts
- group Id
- OG000
- value
- 59
- group Id
- OG001
- value
- 26
- group Id
- OG002
- value
- 85
- units
- Participants
- title
- Baseline
- categories
- measurements
- group Id
- OG000
- spread
- 2.2
- value
- -2.7
- group Id
- OG001
- spread
- 3.1
- value
- -2.6
- group Id
- OG002
- spread
- 2.5
- value
- -2.7
- denoms
- counts
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 18
- group Id
- OG002
- value
- 51
- units
- Participants
- title
- Week 25
- categories
- measurements
- group Id
- OG000
- spread
- 1.7
- value
- -3.3
- group Id
- OG001
- spread
- 3.4
- value
- -2.8
- group Id
- OG002
- spread
- 2.3
- value
- -3.2
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 32
- 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
- The Brief Pain Inventory (BPI) Worst Pain NRS was a 1-item, self-administered questionnaire assessing the "worst" pain in the last 24 hours. The NRS for this item ranged from 0 (no pain) to 10 (pain as bad as you can imagine).
- 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
- Worst pain was assessed in the ITT population, specifically among the Pexidartinib Part 1, Pexidartinib Part 2; Placebo Part 1, Pexidartinib Part 2; and All Pexidartinib Treated participants. Participants who received Placebo Part 1 only or Pexidartinib Part 2 only were not analyzed.
- reporting Status
- POSTED
- time Frame
- By Week 49
- title
- Mean Change From Baseline for Worst Pain Numeric Rating Scale Score (NRS) in Participants Receiving Pexidartinib Compared With Those on Placebo by Week 49
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- units on a scale
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Preserved source evidence · Not medical advice