Table 4:
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.