TABLE 3.
TRAEs (≥10%) in All Patients
| TRAE | Grade 1, No. (%) | Grade 2, No. (%) | Grade 3, No. (%) | Grade 4, No. (%) | Grade 5, No. (%) | Total (n = 107), n (%) |
|---|---|---|---|---|---|---|
| Any TRAE | 13 (12.1) | 36 (33.6) | 55 (51.4) | 3 (2.8) | 0 | 107 (100.0) |
| Peripheral sensory neuropathy | 35 (32.7) | 18 (16.8) | 20 (18.7) | 0 | 0 | 73 (68.2) |
| Leukopenia | 19 (17.8) | 33 (30.8) | 2 (1.9) | 0 | 0 | 54 (50.5) |
| AST increased | 39 (36.4) | 5 (4.7) | 1 (0.9) | 0 | 0 | 45 (42.1) |
| Neutropenia | 13 (12.1) | 19 (17.8) | 12 (11.2) | 1 (0.9) | 0 | 45 (42.1) |
| Alopecia | 37 (34.6) | 5 (4.7) | 1 (0.9) | 0 | 0 | 43 (40.2) |
| Asthenia | 26 (24.3) | 12 (11.2) | 4 (3.7) | 0 | 0 | 42 (39.3) |
| ALT increased | 31 (29.0) | 7 (6.5) | 0 | 0 | 0 | 38 (35.5) |
| Decreased appetite | 30 (28.0) | 3 (2.8) | 1 (0.9) | 0 | 0 | 34 (31.8) |
| Nausea | 27 (25.2) | 4 (3.7) | 0 | 0 | 0 | 31 (29.0) |
| Weight decreased | 16 (15.0) | 11 (10.3) | 0 | 0 | 0 | 27 (25.2) |
| Platelet count decreased | 14 (13.1) | 12 (11.2) | 0 | 0 | 0 | 26 (24.3) |
| Constipation | 21 (19.6) | 3 (2.8) | 0 | 0 | 0 | 24 (22.4) |
| Blood triglycerides increased | 17 (15.9) | 5 (4.7) | 1 (0.9) | 1 (0.9) | 0 | 24 (22.4) |
| Anemia | 12 (11.2) | 8 (7.5) | 3 (2.8) | 0 | 0 | 23 (21.5) |
| Gamma-glutamyltransferase increased | 7 (6.5) | 9 (8.4) | 6 (5.6) | 0 | 0 | 22 (20.6) |
| Pruritus | 13 (12.1) | 7 (6.5) | 1 (0.9) | 0 | 0 | 21 (19.6) |
| Vomiting | 16 (15.0) | 2 (1.9) | 1 (0.9) | 0 | 0 | 19 (17.8) |
| Blood creatine phosphokinase increased | 11 (10.3) | 2 (1.9) | 2 (1.9) | 1 (0.9) | 0 | 16 (15.0) |
| Blood glucose increased | 8 (7.5) | 6 (5.6) | 2 (1.9) | 0 | 0 | 16 (15.0) |
| Hemoglobin decreased | 7 (6.5) | 5 (4.7) | 1 (0.9) | 0 | 0 | 13 (12.1) |
| Protein urine present | 4 (3.7) | 7 (6.5) | 1 (0.9) | 0 | 0 | 12 (11.2) |
| Rash | 9 (8.4) | 3 (2.8) | 0 | 0 | 0 | 12 (11.2) |
| Pyrexia | 6 (5.6) | 5 (4.7) | 0 | 0 | 0 | 11 (10.3) |
| Pain in extremity | 8 (7.5) | 3 (2.8) | 0 | 0 | 0 | 11 (10.3) |
Abbreviation: TRAE, treatment-related adverse event.