Table 4.
Treatment-emergent adverse events occurring in ≥10% of patients (safety population, N = 30)
| TEAE, n (%) | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Any grade |
|---|---|---|---|---|---|
| Hypertension | 11 (36.7%) | 15 (50%) | 26 (86.7%) | ||
| Palmar-plantar erthrodysesthesia syndrome | 10 (33.3%) | 9 (30%) | 3 (10%) | 22 (73.3%) | |
| White blood cell decreased | 12 (40%) | 7 (23.3%) | 2 (6.7%) | 21 (70%) | |
| Neutrophil count decreased | 7 (23.3%) | 5 (16.7%) | 8 (26.7%) | 20 (66.7%) | |
| Vomiting | 11 (36.7%) | 2 (6.7%) | 2 (6.7%) | 15 (50%) | |
| Decreased appetite | 11 (36.7%) | 4 (13.3%) | 15 (50%) | ||
| Nausea | 11 (36.7%) | 2 (6.7%) | 13 (43.3%) | ||
| Malaise | 11 (36.7%) | 1 (3.3%) | 12 (40%) | ||
| Platelet count decreased | 7 (23.3%) | 2 (6.7%) | 1 (3.3%) | 2 (6.7%) | 12 (40%) |
| Diarrhea | 4 (13.3%) | 2 (6.7%) | 4 (13.3%) | 10 (33.3%) | |
| Peripheral neurotoxicity | 8 (26.7%) | 1 (3.3%) | 1 (3.3%) | 10 (33.3%) | |
| Alanine aminotransferase increased | 5 (16.7%) | 3 (10%) | 1 (3.3%) | 9 (30.0%) | |
| Aspartate aminotransferase increased | 4 (13.3%) | 2 (6.7%) | 3 (10.0%) | 9 (30.0%) | |
| Constipation | 4 (13.3%) | 2 (6.7%) | 6 (20%) | ||
| Toothache | 5 (16.7%) | 1 (3.3%) | 6 (20%) | ||
| Fever | 5 (16.7%) | 5 (16.7%) | |||
| Abdominal pain | 3 (10%) | 1 (3.3%) | 1 (3.3%) | 5 (16.7%) | |
| Thyroid-stimulating hormone increased | 3 (10%) | 1 (3.3%) | 4 (13.3%) | ||
| Hypertriglyceridemia | 1 (3.3%) | 1 (3.3%) | 2 (6.7%) | 4 (13.3%) | |
| Dizziness | 4 (13.3%) | 4 (13.3%) | |||
| Proteinuria | 2 (6.7%) | 1 (3.3%) | 3 (10%) | ||
| Hypokalemia | 2 (6.7%) | 1 (3.3%) | 3 (10%) | ||
| Hyponatremia | 1 (3.3%) | 1 (3.3%) | 1 (3.3%) | 3 (10%) | |
| Cough | 2 (6.7%) | 1 (3.3%) | 3 (10%) | ||
| Upper respiratory infection | 3 (10%) | 3 (10%) | |||
| Weight loss | 1 (3.3%) | 2 (6.7%) | 3 (10%) | ||
| Headache | 3 (10%) | 3 (10%) |