Table 2.
Treatment-related adverse events
| 80 mg (n = 39) |
120 mg (n = 3) |
|||||
|---|---|---|---|---|---|---|
| Adverse events | <Grade 3 | ≥Grade 3 | Total | <Grade 3 | ≥Grade 3 | Total |
| Total | 15 (38.5%) | 37 (94.9%) | 3 (100.0%) | 3 (100.0%) | ||
| Hand-foot syndrome | 16 (41.0%) | 4 (10.3%) | 20 (51.3%) | 1 (33.3%) | 2 (66.7%) | 3 (100.0%) |
| Rash | 10 (25.6%) | 2 (5.1%) | 12 (30.8%) | 1 (33.3%) | 0 (0.0%) | 1 (33.3%) |
| Fever | 8 (20.5%) | 0 (0.0%) | 8 (20.5%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Hoarseness | 7 (17.9%) | 0 (0.0%) | 7 (17.9%) | 2 (66.7%) | 0 (0.0%) | 2 (66.7%) |
| Diarrhea | 6 (15.4%) | 1 (2.6%) | 7 (17.9%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Hypertension | 5 (12.8%) | 1 (2.6%) | 6 (15.4%) | 0 (0.0%) | 2 (66.7%) | 2 (66.7%) |
| Impaired liver function | 2 (5.1%) | 4 (10.3%) | 6 (15.4%) | 0 (0.0%) | 1 (33.3%) | 1 (33.3%) |
| Chest distress | 6 (15.4%) | 0 (0.0%) | 6 (15.4%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Myalgia | 5 (12.8%) | 0 (0.0%) | 5 (12.8%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Headache | 3 (7.7%) | 2 (5.1%) | 5 (12.8%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Thrombocytopenia | 3 (7.7%) | 1 (2.6%) | 4 (10.3%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Fatigue | 4 (10.3%) | 0 (0.0%) | 4 (10.3%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Abdominal pain | 3 (7.7%) | 0 (0.0%) | 3 (7.7%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Proctorrhagia | 3 (7.7%) | 0 (0.0%) | 3 (7.7%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Bilirubin elevated | 1 (2.6%) | 2 (5.1%) | 3 (7.7%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Leukocytosis | 1 (2.6%) | 0 (0.0%) | 1 (2.6%) | 1 (33.3%) | 0 (0.0%) | 1 (33.3%) |
| Hemoglobin reduction | 2 (5.1%) | 0 (0.0%) | 2 (5.1%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Decreased appetite | 2 (5.1%) | 0 (0.0%) | 2 (5.1%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Frequent premature ventricular | 2 (5.1%) | 0 (0.0%) | 2 (5.1%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Proteinuria | 1 (2.6%) | 0 (0.0%) | 1 (2.6%) | 1 (33.3%) | 0 (0.0%) | 0 (0.0%) |
| Pruritus | 1 (2.6%) | 0 (0.0%) | 1 (2.6%) | 0 (0.0%) | 1 (33.3%) | 1 (33.3%) |
| Hypothyroidism | 1 (2.6%) | 0 (0.0%) | 1 (2.6%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Hyperthyroidism | 1 (2.6%) | 0 (0.0%) | 1 (2.6%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Neutropenia | 0 (0.0%) | 1 (2.6%) | 1 (2.6%) | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Use of glucocorticoids | 4 (10.3%) | 0 (0.0%) | ||||
See also Table S1.