Table 2.
Adverse events (N = 46).
| Grade 1–5 | Grade ≥3 | ||||
|---|---|---|---|---|---|
| Adverse events | N | % | N | % | |
| Laboratory examinations | Leukopenia | 35 | 76.1 | 8 | 17.4 |
| Neutropenia | 31 | 67.4 | 15 | 32.6 | |
| Thrombocytopenia | 5 | 10.9 | 0 | 0.0 | |
| AST increased | 22 | 47.8 | 3 | 6.5 | |
| ALT increased | 18 | 39.1 | 2 | 4.3 | |
| ALP increased | 22 | 47.8 | 0 | 0.0 | |
| Hyponatremia | 12 | 26.1 | 1 | 2.2 | |
| Hypernatremia | 2 | 4.3 | 0 | 0.0 | |
| Hypokalemia | 5 | 10.9 | 1 | 2.2 | |
| Hyperkalemia | 16 | 34.8 | 0 | 0.0 | |
| Total bilirubin increased | 4 | 8.7 | 0 | 0.0 | |
| Serum creatinine increased | 8 | 17.4 | 0 | 0.0 | |
| Hypoalbuminemia | 27 | 58.7 | 4 | 8.7 | |
| Blood and lymphatic system disorders | Febrile neutropenia | 0 | 0.0 | 0 | 0.0 |
| Anemia | 23 | 50.0 | 7 | 15.2 | |
| Metabolism and nutrition disorders | Anorexia | 20 | 43.5 | 2 | 4.3 |
| Gastrointestinal disorders | Nausea | 15 | 32.6 | 1 | 2.2 |
| Vomiting | 2 | 4.3 | 1 | 2.2 | |
| Oral mucositis | 8 | 17.4 | 0 | 0.0 | |
| Abdominal pains | 5 | 10.9 | 0 | 0.0 | |
| Nervous system disorders | Peripheral motor neuropathy | 8 | 17.4 | 0 | 0.0 |
| Peripheral sensory neuropathy | 29 | 63.0 | 3 | 6.5 | |
| Musculoskeletal and connective tissue disorders | Arthralgia | 4 | 8.7 | 0 | 0.0 |
| Myalgia | 1 | 2.2 | 0 | 0.0 | |
| General disorders and administration site conditions | Fatigue | 28 | 60.9 | 2 | 4.3 |
| Edematous limbs | 10 | 21.7 | 0 | 0.0 | |
| Infusion reactions | 4 | 8.7 | 0 | 0.0 | |
| Immune system disorders | Allergen reaction | 1 | 2.2 | 0 | 0.0 |
| Anaphylaxis | 0 | 0.0 | 0 | 0.0 | |
| Heart failure | Cardiac failure (NYHA) | 0 | 0.0 | 0 | 0.0 |
| Respiratory disorders | Pulmonary fibrosis | 1 | 2.2 | 1 | 2.2 |
AST: aspartate aminotransferase; ALT: alanine aminotransferase; ALP: alkaline phosphatase; NYHA: New York Heart Association.