Table 3.
Adverse eventsa
| Event | Grade 1 |
Grade 2 |
Grade 3 |
Grade 4 |
Grade 5 |
|---|---|---|---|---|---|
| No. of patients with event (%) | |||||
| Hematologic event | |||||
| Neutropenia | 8 (9.5) | 22 (26.2) | 14 (16.7) | 6 (7.1) | 50 (59.5) |
| Anemia | 23 (27.4) | 12 (14.3) | 1 (1.2) | 0 | 36 (42.9) |
| Thrombocytopenia | 18 (21.4) | 6 (7.1) | 2 (2.4) | 0 | 26 (30.9) |
| Nonhematologic event | |||||
| Fatigue | 25 (29.8) | 26 (30.9) | 5 (5.9) | 0 | 56 (66.6) |
| Elevation of AST/ALT | 14 (16.7) | 14 (16.7) | 21 (25.0) | 0 | 49 (58.3) |
| Nausea | 20 (23.8) | 10 (11.9) | 1 (1.2) | 0 | 31 (36.9) |
| Alopecia | 10 (11.9) | 7 (8.3) | 2 (2.4) | 1 (1.2) | 20 (23.8) |
| Diarrhea | 12 (14.3) | 4 (4.8) | 0 | 0 | 16 (19.0) |
| Constipation | 12 (14.3) | 2 (2.4) | 1 (1.2) | 0 | 15 (17.9) |
| Peripheral neuropathy | 8 (9.5) | 3 (3.6) | 1 (1.2) | 0 | 12 (14.3) |
| Rash | 8 (9.5) | 2 (2.4) | 2 (2.4) | 0 | 12 (14.3) |
| Vomiting | 8 (9.5) | 1 (1.2) | 1 (1.2) | 0 | 10 (11.9) |
| Oral mucositis | 6 (7.1) | 3 (3.6) | 0 | 0 | 9 (10.7) |
ALT, alanine aminotransferase; AST, aspartate aminotransferase; no., number.
a
The safety analysis set included the 84 patients who received at least one dose of study drugs.