Table 3.
Summary of adverse events reported in ≥10% of the patients
| Single-agent arm | Combination arm | ||||
| N=39 | N=53 | ||||
| n (%) | All grades | Grade ≥3 | n (%) | All grades | Grade ≥3 |
| Patients with ≥1 event | 39 (100) | 17 (43.6) | Patients with ≥1 event | 51 (96.2) | 25 (47.2) |
| Constipation | 12 (30.8) | 0 | Fatigue | 15 (28.3) | 1 (1.9) |
| Fever | 11 (28.2) | 0 | Decreased appetite | 14 (26.4) | 1 (1.9) |
| Fatigue | 10 (25.6) | 0 | Nausea | 13 (24.5) | 1 (1.9) |
| Abdominal pain | 9 (23.1) | 0 | Abdominal pain | 11 (20.8) | 3 (5.7) |
| Chills | 8 (20.5) | 0 | Diarrhea | 11 (20.8) | 0 |
| Myalgia | 8 (20.5) | 0 | Fever | 11 (20.8) | 0 |
| Nausea | 8 (20.5) | 0 | Cough | 10 (18.9) | 0 |
| Cough | 7 (17.9) | 0 | Anemia | 9 (17.0) | 4 (7.5) |
| Decreased appetite | 7 (17.9) | 1 (2.6) | Back pain | 9 (17.0) | 0 |
| Anemia | 6 (15.4) | 5 (12.8) | Constipation | 9 (17.0) | 0 |
| Diarrhea | 6 (15.4) | 0 | Rash | 9 (17.0) | 0 |
| Dyspnea | 6 (15.4) | 1 (2.6) | Vomiting | 9 (17.0) | 1 (1.9) |
| Ascites | 5 (12.8) | 3 (7.7) | Chills | 8 (15.1) | 0 |
| Asthenia | 5 (12.8) | 0 | Headache | 8 (15.1) | 0 |
| Rash | 5 (12.8) | 0 | Pruritus | 8 (15.1) | 0 |
| Lymphopenia | 4 (10.3) | 1 (2.6) | Blood creatinine increased | 7 (13.2) | 0 |
| Edema peripheral | 4 (10.3) | 0 | Edema peripheral | 7 (13.2) | 0 |
| Vomiting | 4 (10.3) | 0 | Aspartate aminotransferase increased | 6 (11.3) | 0 |
| Hyperglycemia | 6 (11.3) | 1 (1.9) | |||