Table 3.
Treatment-related adverse events.
| All patients (n = 70) |
|||||
|---|---|---|---|---|---|
| Any Grade | Grade 1–2 | Grade 3 | Grade 4 | Grade 5 | |
| Any | 70 (100.0) | 54 (77.1) | 11 (15.7) | 5 (7.1) | 0 |
| Blood and lymphatic system disorders | |||||
| Leukopenia | 60 (85.7) | 49 (70.0) | 8 (11.4) | 3 (4.3) | 0 |
| Neutropenia | 44 (62.9) | 32 (45.7) | 7 (10.0) | 5 (7.1) | 0 |
| Febrile neutropenia | 2 (2.9) | 0 | 2 (2.9) | 0 | 0 |
| Anemia | 64 (91.4) | 63 (90.0) | 1 (1.4) | 0 | 0 |
| Thrombocytopenia | 24 (34.3) | 22 (31.4) | 1 (1.4) | 1 (1.4) | 0 |
| Gastrointestinal disorders | |||||
| Nausea | 9 (12.9) | 9 (12.9) | 0 | 0 | 0 |
| Vomiting | 8 (11.4) | 8 (11.4) | 0 | 0 | 0 |
| Abdominal pain | 1 (1.4) | 1 (1.4) | 0 | 0 | 0 |
| Diarrhea | 1 (1.4) | 1 (1.4) | 0 | 0 | 0 |
| Abdominal distension | 3 (4.3) | 3 (4.3) | 0 | 0 | 0 |
| Constipation | 3 (4.3) | 3 (4.3) | 0 | 0 | 0 |
| Mucositis | 2 (2.9) | 2 (2.9) | 0 | 0 | 0 |
| Hepatobiliary disorders | |||||
| Elevated alanine aminotransferase activity | 24 (34.3) | 20 (28.6) | 4 (5.7) | 0 | 0 |
| Elevated aspartate aminotransferase activity | 22 (31.4) | 20 (28.6) | 2 (2.9) | 0 | 0 |
| Elevated blood bilirubin levels | 3 (4.3) | 3 (4.3) | 0 | 0 | 0 |
| Renal and urinary disorders | |||||
| Elevated creatinine levels | 6 (8.6) | 6 (8.6) | 0 | 0 | 0 |
| Endocrine disorders | |||||
| Hypothyroidism | 5 (7.1) | 5 (7.1) | 0 | 0 | 0 |
| Nervous system disorders | |||||
| Peripheral sensory neuropathy | 12 (17.1) | 12 (17.1) | 0 | 0 | 0 |
| Skin and subcutaneous tissue disorders | |||||
| Rash | 11 (15.7) | 11 (15.7) | 0 | 0 | 0 |
| Respiratory, thoracic, and mediastinal disorders | |||||
| Cough | 3 (4.3) | 3 (4.3) | 0 | 0 | 0 |
| Infections and infestations | |||||
| Paronychia | 1 (1.4) | 1 (1.4) | 0 | 0 | 0 |
| Phlebitis infective | 1 (1.4) | 0 | 1 (1.4) | 0 | 0 |
| Tracheitis | 1 (1.4) | 1 (1.4) | 0 | 0 | 0 |
| Cardiac disorders | |||||
| Palpitations | 1 (1.4) | 1 (1.4) | 0 | 0 | 0 |
| General disorders | |||||
| Alopecia | 70 (100.0) | 70 (100.0) | 0 | 0 | 0 |
| Fatigue | 23 (32.9) | 20 (28.6) | 3 (4.3) | 0 | 0 |
| Fever | 4 (5.7) | 4 (5.7) | 0 | 0 | 0 |
| Edema | 3 (4.3) | 3 (4.3) | 0 | 0 | 0 |
| Hypoalbuminemia | 16 (22.9) | 16 (22.9) | 0 | 0 | 0 |
| Hypokalemia | 1 (1.4) | 1 (1.4) | 0 | 0 | 0 |
| Potential immune-related AEs | |||||
| Elevated alanine aminotransferase activity | 3 (4.3) | 0 | 3 (4.3) | 0 | 0 |
| Elevated aspartate aminotransferase activity | 2 (2.9) | 0 | 2 (2.9) | 0 | 0 |
| Elevated creatinine levels | 1 (1.4) | 1 (1.4) | 0 | 0 | 0 |
| Hypothyroidism | 5 (7.1) | 5 (7.1) | 0 | 0 | 0 |
Abbreviation: AE, adverse effect.