Table 4:

Adverse events occurring in ≥10% of patients in part 1 or part 2

Adverse event, n (%)	Part 1				Part 2
	Pexidartinib n=61		Placebo n=59		Crossover pexidartinib n=30
	Any grade	Grade 3/4	Any grade	Grade 3/4	Any grade	Grade 3/4
Skin disorders
Hair color changes	41 (67)	0	2 (3)	0	25 (83)	0
Pruritus	10 (16)	0	2 (3)	0	8 (27)	0
Rash	8 (13)	1 (2)	2 (3)	0	6 (20)	0
Rash maculopapular	6 (10)	0	1 (2)	0	2 (7)	0
Erythema	1 (2)	0	0	0	5 (17)	0
Gastrointestinal disorders
Nausea	23 (38)	0	24 (41)	0	6 (20)	0
Diarrhea	12 (20)	0	15 (25)	0	8 (27)	0
Abdominal pain	10 (16)	0	6 (10)	0	1 (3)	0
Vomiting	12 (20)	1 (2)	3 (5)	0	1 (3)	0
Dry mouth	6 (10)	0	2 (3)	0	4 (13)	0
Constipation	7 (12)	0	3 (5)	0	3 (10)	0
Stomatitis	4 (7)	0	1 (2)	0	3 (10)	0
General disorders
Fatigue	33 (54)	0	21 (36)	0	5 (17)	0
Asthenia	6 (10)	0	3 (5)	0	5 (17)	0
Facial edema	8 (13)	0	1 (2)	0	6 (20)	1 (3)
Peripheral edema	8 (13)	0	2 (3)	0	5 (17)	0
Investigations
AST increase	24 (39)	6 (10)	0	0	5 (17)	1 (3)
ALT increase	17 (28)	6 (10)	1 (2)	0	7 (23)	2 (7)
Alkaline phosphatase increase	9 (15)	4 (7)	0	0	1 (3)	1 (3)
Lactate dehydrogenase increase	7 (12)	1 (2)	0	0	3 (10)	0
Nervous disorders
Dysgeusia	15 (25)	0	1 (2)	0	7 (23)	0
Headache	11 (18)	0	11 (19)	0	5 (17)	0
Dizziness	6 (10)	1 (2)	9 (15)	0	4 (13)	0
Musculoskeletal disorders
Arthralgia	14 (23)	2 (3)	15 (25)	1 (2)	6 (20)	0
Pain in extremity	4 (7)	0	4 (7)	1 (2)	3 (10)	0
Eye disorders
Periorbital edema	11 (18)	1 (2)	1 (2)	0	3 (10)	0
Eyelid edema	1 (2)	0	0	0	3 (10)	0
Metabolic/nutritional disorders
Decreased appetite	10 (16)	0	6 (10)	0	3 (10)	0
Vascular disorders						2 (7)
Hypertension	9 (15)	3 (5)	6 (10)	0	6 (20)	2 (7)

ALT=alanine aminotransferase. AST=aspartate aminotransferase.