Table 3.
Incidence and severity of treatment-related adverse events in ≥5% of patients treated at the maximum tolerated dose
| AE^ (N = 42) |
Grade 1 n (%) |
Grade 2 n (%) |
Grade 3 n (%) |
All Grades n (%) |
|---|---|---|---|---|
| Mucosal inflammation and stomatitis | 19 (45.2) | 1 (2.4) | 3 (7.1) | 23 (54.7) |
| Nausea | 15 (35.7) | 1 (2.4) | 1 (2.4) | 17 (40.5) |
| Hyperglycemia | 7 (16.7) | 3 (7.1) | 1 (2.4) | 11 (26.2) |
| Vomiting | 8 (19.0) | 1 (2.4) | 1 (2.4) | 10 (23.8) |
| Asthenia | 3 (7.1) | 5 (11.9) | 1 (2.4) | 9 (21.4) |
| Decreased appetite | 6 (14.3) | 3 (7.1) | 0 | 9 (21.4) |
| Fatigue | 8 (19.0) | 1 (2.4) | 0 | 9 (21.4) |
| Dysgeusia | 8 (19.0) | 0 | 0 | 8 (19.0) |
| AST increased | 1 (2.4) | 3 (7.1) | 2 (4.8) | 6 (14.3) |
| Diarrhea | 6 (14.3) | 0 | 0 | 6 (14.3) |
| Dermatitis acneiform and rash | 6 (14.3) | 0 | 0 | 6 (14.3) |
| ALT increased | 1 (2.4) | 1 (2.4) | 3 (7.1) | 5 (11.9) |
| Pyrexia | 4 (9.5) | 0 | 1 (2.4) | 5 (11.9) |
| Dry mouth | 4 (9.5) | 0 | 0 | 4 (9.5) |
| Hypertriglyceridemia | 4 (9.5) | 0 | 0 | 4 (9.5) |
| Constipation | 3 (7.1) | 0 | 0 | 3 (7.1) |
| Dehydration | 0 | 3 (7.1) | 0 | 3 (7.1) |
| Dry skin | 3 (7.1) | 0 | 0 | 3 (7.1) |
| Hypercholesterolemia | 3 (7.1) | 0 | 0 | 3 (7.1) |
| Lymphopenia | 1 (2.4) | 2 (4.8) | 0 | 3 (7.1) |
^
No grade 4 and grade 5 treatment-related AEs were reported.
AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase.