Table 4.
Adverse events (≥ 5%) occurring in the safety sets (n = 46)
| Adverse event | All grade n (%) |
≥ G3 n (%) |
|---|---|---|
| Anemia | 45 (97.8) | 2 (4.3) |
| Neutropenia | 42 (91.3) | 30 (65.2) |
| Leukopenia | 35 (76.1) | 11 (23.9) |
| Thrombocytopenia | 26 (56.5) | 0 |
| Peripheral sensory neuropathy | 39 (84.8) | 1 (2.2) |
| Malaise | 38 (82.6) | 0 |
| Alopecia | 36 (78.3) | 0 |
| Nausea | 35 (76.1) | 5 (10.9) |
| Anorexia | 35 (76.1) | 5 (10.9) |
| Diarrhea | 27 (58.7) | 5 (10.9) |
| Fatigue | 27 (58.7) | 2 (4.3) |
| Mucositis oral | 25 (54.3) | 2 (4.3) |
| Hypertension | 25 (54.3) | 4 (8.7) |
| Vomiting | 14 (30.4) | 2 (4.3) |
| Febrile neutropenia | 12 (26.1) | 12 (26.1) |
| Constipation | 9 (19.6) | 0 |
| Fever | 9 (19.6) | 2 (4.3) |
| Hiccups | 8 (17.4) | 0 |
| Epistaxis | 7 (15.2) | 0 |
| Palmar–plantar erythrodysesthesia syndrome | 7 (15.2) | 0 |
| Skin hyperpigmentation | 5 (10.9) | 0 |
| Thromboembolic event | 5 (10.9) | 2 (4.3) |
| Dry skin | 4 (8.7) | 0 |
| Hypoalbuminemia | 3 (6.5) | 0 |
| Abdominal pain | 3 (6.5) | 0 |
| Dysgeusia | 3 (6.5) | 0 |