Table 3.
Adverse Events Regardless of Study Drug Relationship
| Preferred Term, n (%) | All Grade | Grade 3/4 |
|---|---|---|
| Total | 104 (100) | 77 (74.0) |
| Hematologic AEs or laboratory abnormalities occurring at > 10% incidence | ||
| Neutropeniaa | 72 (69.2) | 53 (51.0) |
| Anemia | 30 (28.8) | 10 (9.6) |
| Thrombocytopenia | 29 (27.9) | 1 (1.0) |
| AST increased | 20 (19.2) | 1 (1.0) |
| Hypophosphatemia | 20 (19.2) | 6 (5.8) |
| Hyperglycemia | 19 (18.3) | 7 (6.7) |
| Hypokalemia | 16 (15.4) | 1 (1.0) |
| ALT increased | 15 (14.4) | 0 |
| GGT increased | 11 (10.6) | 2 (1.9) |
| Platelet count decreased | 11 (10.6) | 0 |
| Nonhematologic AEs occurring at > 10% incidence and grade 3/4 incidence of ≥ 1.5% | ||
| Stomatitis | 42 (40.4) | 3 (2.9) |
| Nausea | 35 (33.7) | 2 (1.9) |
| Diarrhea | 29 (27.9) | 2 (1.9) |
| Pyrexia | 19 (18.3) | 3 (2.9) |
| Pneumonitis | 15 (14.4) | 5 (4.8) |
| Dyspnea | 13 (12.5) | 4 (3.8) |
AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; GGT, gamma-glutamyltransferase.
a
Neutropenia or decreased neutrophil count.