Table 4.
Most common adverse events (incidence > 5%) and the adverse events ≥ Grade 3
| AE at any level, n (%) | AE ≥ level 3, n (%) | |||||
|---|---|---|---|---|---|---|
| total | Cohort 1 | Cohort 2 | total | Cohort 1 | Cohort 2 | |
| Hypertension | 31 (62.0%) | 19 (73.1%) | 12 (50.0%) | 4 (8.0%) | 3 (11.5%) | 1 (4.2%) |
| Hand-foot syndrome | 27 (54.0%) | 14 (53.8%) | 13 (54.2%) | 3 (6.0%) | 2 (7.7%) | 1 (4.2%) |
| Elevated bilirubin | 26 (52.0%) | 15 (57.7%) | 11 (45.8%) | 2 (4.0%) | 1 (3.8%) | 1 (4.2%) |
| Fatigue | 28 (56.0%) | 16 (61.5%) | 12 (50.0%) | – | – | – |
| Proteinuria | 25 (50.0%) | 13 (50.0%) | 12 (50.0%) | 1 (2.0%) | – | 1 (4.2%) |
| Diarrhea | 26 (52.0%) | 16 (61.5%) | 10 (41.7%) | 4 (8.0%) | 4 (15.4%) | – |
| Elevated Alanine Aminotransferase | 9 (18.0%) | 4 (15.4%) | 5 (20.8%) | 1 (2.0%) | 1 (3.8%) | – |
| Hoarseness | 11 (22.0%) | 6 (23.1%) | 5 (20.8%) | – | – | |
| Hypertriglyceridemia | 13 (26.0%) | 7 (26.9%) | 6 (25.0%) | – | – | – |
| Hypercholesterolemia | 10 (20.0%) | 5 (19.2%) | 5 (20.8%) | – | – | – |
| Elevated aspartate aminotransferase | 14 (28.0%) | 9 (34.6%) | 5 (20.8%) | 1 (2.0%) | 1 (3.8%) | – |
| Anorexia | 18 (36.0%) | 10 (38.5%) | 8 (33.3%) | – | – | – |
| Bleeding | 13 (26.0%) | 10 (38.5%) | 3 (12.5%) | 2 (4.0%) | 2 (7.7%) | – |
| Leukopenia | 17 (34.0%) | 8 (30.0%) | 9 (37.5%) | – | – | – |
| Thrombocytopenia | 18 (36.0%) | 8 (30.0%) | 9 (37.5%) | – | – | – |
| Abdominal pain | 20 (40.0%) | 10 (38.5%) | 10 (41.7%) | 2 (4.0%) | 1 (3.8%) | 1 (4.2%) |
| Hypothyroidism | 31 (62.0%) | 16 (61.5%) | 15 (62.5%) | – | – | – |
| Prolonged QT interval | 18 (36.0%) | 10 (38.5%) | 8 (33.3%) | 1 (2.0%) | 1 (3.8%) | – |
| Elevated low-density lipoprotein | 16 (32.0%) | 9 (34.6%) | 7 (29.2%) | – | – | – |
| Nausea | 4 (8.0%) | 3 (11.5%) | 1 (4.2%) | – | – | – |
| Fever | 3 (6.0%) | 1 (3.8%) | 2 (8.3%) | – | – | – |
| Hepatalgia | 2(4.0%) | 2 (7.7%) | – | – | – | – |
| Cough | 9 (18.0%) | 6 (23.1%) | 3 (12.5%) | – | – | – |
| Vomit | 6 (12.0%) | 3 (11.5%) | 3 (12.5%) | – | – | – |
| Anemia | 3 (6.0%) | 1 (3.8%) | 2 (8.3%) | 1 (2.0%) | – | 1 (4.2%) |
| Weight loss | 6 (12.0%) | 5 (19.2%) | 1 (4.2%) | – | – | |
| Headache | 6 (12.0%) | 5 (19.2%) | 1 (4.2%) | – | – | – |
| Chest tightness | 4 (8.0%) | 2 (7.7%) | 2 (8.3%) | – | – | – |
| Elevated lipase in blood | 6 (12.0%) | 6 (23.1%) | – | 1 (2.0%) | 1 (3.8%) | – |
| Toothache | 4 (8.0%) | 4 (15.4%) | – | – | – | – |
| Pharyngalgia | 23 (46.0%) | 11 (42.3%) | 12 (50.0%) | – | – | – |
| Low back pain | 6 (12.0%) | 4 (15.4%) | 2 (8.3%) | 1 (2.0%) | – | 1 (4.2%) |
| Musculoskeletal pain | 7 (14.0%) | 4 (15.4%) | 3 (12.5%) | – | – | – |
| Arthralgia | 6 (12.0%) | 3 (11.5%) | 3 (12.5%) | – | – | – |