Percentage of Participants Reporting Frequent (≥10%) Treatment-Emergent Adverse Events by Preferred Term
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
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
After the first dose of treatment up to 28 days after the last dose
What was measured
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened after the first dose of treatment and within 28 days after the last dose. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 was used to grade adverse events. Any Grade and Grade ≥3 (severe) TEAEs are reported. TEAEs were coded using MedDRA version 17.1.
Analysis population: All safety events were assessed in the Safety Analysis Set.
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.
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 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
Pexidartinib Part 1 and Part 2
61
Placebo Part 1, Pexidartinib Part 2
30
All Pexidartinib Treated
91
Reported measurements
Any Hair color changes
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
67.2
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
3.4
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
73.8
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
83.3
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
76.9
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Hair color changes
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
0
Not reported
Not reported
Not reported
Not reported
Any Pruritis
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
9.8
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
3.4
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
16.4
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
20.0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
17.6
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Pruritis
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
1.6
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
1.1
Not reported
Not reported
Not reported
Not reported
Any Rash maculopapular
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
9.8
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
1.7
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
14.8
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
10.0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
13.2
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Rash maculopapular
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
1.6
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
1.1
Not reported
Not reported
Not reported
Not reported
Any Pruritis generalized
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
8.2
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
8.2
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
10.0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
8.8
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Pruritis generalized
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
0
Not reported
Not reported
Not reported
Not reported
Any Erythema
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
1.6
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
3.3
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
20.0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
8.8
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Erythema
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
0
Not reported
Not reported
Not reported
Not reported
Any Dry skin
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
3.3
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
3.4
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
6.6
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
10.0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
7.7
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Dry skin
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
3.3
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
1.1
Not reported
Not reported
Not reported
Not reported
Any Photosensitivity reaction
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
1.6
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
10.0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
4.4
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Photosensitivity reaction
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
0
Not reported
Not reported
Not reported
Not reported
Any Nausea
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
37.7
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
40.7
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
44.3
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
20.0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
36.3
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Nausea
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
0
Not reported
Not reported
Not reported
Not reported
Any Diarrhea
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
19.7
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
25.4
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
26.2
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
30.0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
27.5
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Diarrhea
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
0
Not reported
Not reported
Not reported
Not reported
Any Vomiting
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
19.7
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
5.1
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
23.0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
6.7
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
17.6
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Vomiting
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
1.6
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
1.6
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
1.1
Not reported
Not reported
Not reported
Not reported
Any Abdominal Pain
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
16.4
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
10.2
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
21.3
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
6.7
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
16.5
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Abdominal Pain
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
0
Not reported
Not reported
Not reported
Not reported
Any Dry mouth
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
9.8
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
3.4
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
13.1
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
13.3
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
13.2
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Dry mouth
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
0
Not reported
Not reported
Not reported
Not reported
Any Constipation
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
11.5
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
5.1
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
14.8
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
10.0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
13.2
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Constipation
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
0
Not reported
Not reported
Not reported
Not reported
Any Stomatitis
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
6.6
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
1.7
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
8.2
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
10.0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
8.8
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Stomatitis
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
0
Not reported
Not reported
Not reported
Not reported
Any Fatigue
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
54.1
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
35.6
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
55.7
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
26.7
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
46.2
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Fatigue
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
0
Not reported
Not reported
Not reported
Not reported
Any Edema peripheral
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
13.1
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
3.4
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
16.4
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
20.0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
17.6
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Edema peripheral
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
0
Not reported
Not reported
Not reported
Not reported
Any Face edema
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
13.1
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
1.7
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
14.8
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
20.0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
16.5
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Face edema
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
1.6
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
3.3
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
2.2
Not reported
Not reported
Not reported
Not reported
Any Asthenia
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
9.8
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
5.1
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
11.5
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
20.0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
14.3
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Asthenia
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
0
Not reported
Not reported
Not reported
Not reported
Any Pyrexia
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
6.6
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
1.7
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
8.2
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
13.3
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
9.9
Not reported
Not reported
Not reported
Not reported
Grade ≥ Pyrexia
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
0
Not reported
Not reported
Not reported
Not reported
Any AST increased
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
39.3
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
44.3
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
16.7
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
35.2
Not reported
Not reported
Not reported
Not reported
Grade ≥3 AST increased
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
9.8
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
9.8
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
6.7
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
8.8
Not reported
Not reported
Not reported
Not reported
Any ALT increased
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
27.9
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
1.7
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
31.1
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
23.3
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
28.6
Not reported
Not reported
Not reported
Not reported
Grade ≥3 ALT increased
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
9.8
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
9.8
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
10.0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
9.9
Not reported
Not reported
Not reported
Not reported
Any ALP increased
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
14.8
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
14.8
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
3.3
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
11.0
Not reported
Not reported
Not reported
Not reported
Grade ≥3 ALP increased
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
6.6
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
6.6
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
3.3
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
5.5
Not reported
Not reported
Not reported
Not reported
Any LDH increased
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
11.5
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
11.5
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
10.0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
11.0
Not reported
Not reported
Not reported
Not reported
Grade ≥3 LDH increased
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
1.6
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
1.6
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
1.1
Not reported
Not reported
Not reported
Not reported
Any Weight increased
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
3.3
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
4.9
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
10.0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
6.6
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Weight increased
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
0
Not reported
Not reported
Not reported
Not reported
Any Dysgeusia
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
24.6
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
1.7
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
27.9
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
23.3
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
26.4
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Dysgeusia
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
0
Not reported
Not reported
Not reported
Not reported
Any Headache
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
19.7
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
18.6
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
23.0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
20.0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
22.0
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Headache
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
1.6
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
1.1
Not reported
Not reported
Not reported
Not reported
Any Dizziness
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
9.8
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
15.3
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
13.1
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
13.3
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
13.2
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Dizziness
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
1.6
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
1.6
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
1.1
Not reported
Not reported
Not reported
Not reported
Any Paresthesia
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
1.6
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
1.7
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
8.2
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
10.0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
8.8
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Paresthesia
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
0
Not reported
Not reported
Not reported
Not reported
Any Memory impairment
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
1.7
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
1.6
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
10.0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
4.4
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Memory impairment
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
0
Not reported
Not reported
Not reported
Not reported
Any Arthralgia
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
23.0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
25.4
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
27.9
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
30.0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
28.6
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Arthralgia
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
3.3
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
1.7
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
3.3
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
2.2
Not reported
Not reported
Not reported
Not reported
Any Pain in extremity
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
6.6
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
6.8
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
9.8
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
13.3
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
11.0
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Pain in extremity
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
1.7
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
0
Not reported
Not reported
Not reported
Not reported
Any Periorbital edema
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
18.0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
1.7
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
24.6
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
13.3
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
20.0
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Periorbital edema
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
1.6
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
1.6
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
1.1
Not reported
Not reported
Not reported
Not reported
Any Eyelid edema
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
3.3
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
4.9
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
10.0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
6.6
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Eyelid edema
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
0
Not reported
Not reported
Not reported
Not reported
Any Decreased appetite
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
16.4
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
10.2
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
18.0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
10.0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
15.4
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Decreased appetite
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
0
Not reported
Not reported
Not reported
Not reported
Any Hypertension
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
14.8
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
10.2
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
19.7
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
30.0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
13.1
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Hypertension
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
4.9
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
4.9
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
6.7
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
5.5
Not reported
Not reported
Not reported
Not reported
Any Upper respiratory tract infection
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
1.6
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
11.5
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
3.3
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
8.8
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Upper respiratory tract infection
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
0
Not reported
Not reported
Not reported
Not reported
Any Cough
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
4.9
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
5.1
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
6.6
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
10.0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
7.7
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Cough
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
0
Not reported
Not reported
Not reported
Not reported
Any Dyspnea
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
1.6
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
4.9
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
10.0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
7.7
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Dyspnea
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
0
Not reported
Not reported
Not reported
Not reported
Any Insomnia
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
4.9
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
3.4
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
4.9
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
10.0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
6.6
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Insomnia
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
0
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
0
Not reported
Not reported
Not reported
Not reported
Any Rash
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
14.8
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
5.1
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
27.9
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
23.3
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
26.4
Not reported
Not reported
Not reported
Not reported
Grade ≥3 Rash
Values in Percentage of participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Pexidartinib Part 1
1.6
Not reported
Not reported
Not reported
Not reported
Placebo Part 1
0
Not reported
Not reported
Not reported
Not reported
Pexidartinib Part 1 and Part 2
1.6
Not reported
Not reported
Not reported
Not reported
Placebo Part 1, Pexidartinib Part 2
0
Not reported
Not reported
Not reported
Not reported
All Pexidartinib Treated
1.1
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
67.2
group Id
OG001
value
3.4
group Id
OG002
value
73.8
group Id
OG003
value
83.3
group Id
OG004
value
76.9
title
Any Hair color changes
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
title
Grade ≥3 Hair color changes
categories
measurements
group Id
OG000
value
9.8
group Id
OG001
value
3.4
group Id
OG002
value
16.4
group Id
OG003
value
20.0
group Id
OG004
value
17.6
title
Any Pruritis
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1.6
group Id
OG003
value
0
group Id
OG004
value
1.1
title
Grade ≥3 Pruritis
categories
measurements
group Id
OG000
value
9.8
group Id
OG001
value
1.7
group Id
OG002
value
14.8
group Id
OG003
value
10.0
group Id
OG004
value
13.2
title
Any Rash maculopapular
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1.6
group Id
OG003
value
0
group Id
OG004
value
1.1
title
Grade ≥3 Rash maculopapular
categories
measurements
group Id
OG000
value
8.2
group Id
OG001
value
0
group Id
OG002
value
8.2
group Id
OG003
value
10.0
group Id
OG004
value
8.8
title
Any Pruritis generalized
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
title
Grade ≥3 Pruritis generalized
categories
measurements
group Id
OG000
value
1.6
group Id
OG001
value
0
group Id
OG002
value
3.3
group Id
OG003
value
20.0
group Id
OG004
value
8.8
title
Any Erythema
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
0
group Id
OG004
value
0
title
Grade ≥3 Erythema
categories
measurements
group Id
OG000
value
3.3
group Id
OG001
value
3.4
group Id
OG002
value
6.6
group Id
OG003
value
10.0
group Id
OG004
value
7.7
title
Any Dry skin
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
3.3
group Id
OG004
value
1.1
title
Grade ≥3 Dry skin
denoms
counts
group Id
OG000
value
61
group Id
OG001
value
59
group Id
OG002
value
61
group Id
OG003
value
30
group Id
OG004
value
91
units
Participants
description
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened after the first dose of treatment and within 28 days after the last dose. The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 was used to grade adverse events. Any Grade and Grade ≥3 (severe) TEAEs are reported. TEAEs were coded using MedDRA version 17.1.
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
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
OG002
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
OG003
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
OG004
title
All Pexidartinib Treated
param Type
NUMBER
population Description
All safety events were assessed in the Safety Analysis Set.
reporting Status
POSTED
time Frame
After the first dose of treatment up to 28 days after the last dose
title
Percentage of Participants Reporting Frequent (≥10%) Treatment-Emergent Adverse Events by Preferred Term
Triangle