Table 4.
Most common study drug-related nonhematologic AEs (occurring in ≥10 % of patients)
| Nonhematologic AE, n (%) | Any grade (n = 61) | Grade 3/4 (n = 61) |
|---|---|---|
| Nausea | 24 (39.3) | 2 (3.3) |
| Headache | 20 (32.8) | 3 (4.9) |
| Fatigue | 18 (29.5) | 1 (1.6) |
| Diarrhea | 17 (27.9) | 4 (6.6) |
| Vomiting | 16 (26.2) | 2 (3.3) |
| Pruritus | 15 (24.6) | 1 (1.6) |
| Muscle spasms | 13 (21.3) | 2 (3.3) |
| Upper abdominal pain | 12 (19.7) | 1 (1.6) |
| Rash | 10 (16.4) | 1 (1.6) |
| Dizziness | 8 (13.1) | 1 (1.6) |
| Arthralgia | 7 (11.5) | 1 (1.6) |
| Bone pain | 7 (11.5) | 1 (1.6) |
| Myalgia | 7 (11.5) | 1 (1.6) |
| Peripheral edema | 7 (11.5) | 1 (1.6) |
AE adverse event