Table 4.
TEAEs occurring in ≥ 10% of patients
| Pexidartinib (N = 40) | ||
|---|---|---|
| TEAE, n (%) | Any grade | Grade ≥ 3 |
| Patients with any TEAE | 40 (100) | 16 (40.0) |
| Skin and subcutaneous tissue disorders | ||
| Hair color changes | 31 (77.5) | 0 |
| Pruritus | 19 (47.5) | 0 |
| Rash | 17 (42.5) | 1 (2.5) |
| Skin discoloration | 7 (17.5) | 0 |
| Drug eruption | 5 (12.5) | 0 |
| Abnormal hair texture | 5 (12.5) | 0 |
| Investigations | ||
| ALT increased | 24 (60.0) | 8 (20.0) |
| AST increased | 23 (57.5) | 5 (12.5) |
| Blood lactate dehydrogenase increased | 19 (47.5) | 0 |
| Gamma-glutamyl transferase increased | 15 (37.5) | 7 (17.5) |
| White blood cell count decreased | 14 (35.0) | 0 |
| Blood ALP increased | 12 (30.0) | 0 |
| Neutrophil count decreased | 11 (27.5) | 0 |
| Blood creatine phosphokinase increased | 8 (20.0) | 1 (2.5) |
| Bilirubin conjugated increased | 6 (15.0) | 2 (5.0) |
| Blood bilirubin increased | 6 (15.0) | 2 (5.0) |
| Lymphocyte count decreased | 5 (12.5) | 1 (2.5) |
| General disorders and administration-site conditions | ||
| Facial edema | 17 (42.5) | 0 |
| Fatigue | 12 (30.0) | 0 |
| Peripheral edema | 4 (10.0) | 0 |
| Swelling of the face | 4 (10.0) | 0 |
| Gastrointestinal disorders | ||
| Nausea | 6 (15.0) | 0 |
| Diarrhea | 5 (12.5) | 0 |
| Dry mouth | 5 (12.5) | 0 |
| Constipation | 4 (10.0) | 0 |
| Nervous system disorders | ||
| Dizziness | 4 (10.0) | 0 |
| Dysgeusia | 4 (10.0) | 0 |
| Eye disorders | ||
| Periorbital edema | 9 (22.5) | 0 |
| Metabolism and nutrition disorders | ||
| Decreased appetite | 4 (10.0) | 0 |
| Hypokalemia | 4 (10.0) | 0 |
| Blood and lymphatic system disorders | ||
| Anemia | 8 (20.0) | 0 |
| Infections and infestations | ||
| Nasopharyngitis | 5 (12.5) | 0 |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia | 4 (10.0) | 1 (2.5) |
| Vascular disorders | ||
| Hypertension | 5 (12.5) | 1 (2.5) |
If a patient had both missing and nonmissing NCI-CTCAE grades for a TEAE, the missing NCI-CTCAE grade was treated as the lowest-severity grade. If a patient had > 1 event per SOC (or PT) level, the patient was counted once at each level of summation
ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; NCI-CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Events; PT, preferred term; SOC, system organ class; TEAE, treatment-emergent adverse event