Table 5.
Most frequent treatment-related AEs present in >10% of patients in the safety population (n = 66)
| Preferred Term | Number of Patients (%) |
||||
|---|---|---|---|---|---|
| Grade 1 | Grade 2 | Grade 3 | Grade 4 | Total | |
| Any AE | 10 (15.2) | 20 (30.3) | 23 (34.8) | 7 (10.6) | 60 (90.9) |
| Nonhematologic | |||||
| Diarrhea | 24 (36.4) | 10 (15.2) | 5 (7.6) | 0 | 39 (59.1) |
| Vomiting | 27 (40.9) | 9 (13.6) | 1 (1.5) | 0 | 37 (56.1) |
| Nausea | 15 (22.7) | 4 (6.1) | 0 | 0 | 19 (28.8) |
| Abdominal pain | 10 (15.2) | 6 (9.1) | 1 (1.5) | 0 | 17 (25.8) |
| Fatigue | 10 (15.2) | 2 (3.0) | 0 | 0 | 12 (18.2) |
| Decreased appetite | 7 (10.6) | 4 (6.1) | 0 | 0 | 11 (16.7) |
| Constipation | 3 (4.5) | 4 (6.1) | 0 | 0 | 7 (10.6) |
| Hematologic | |||||
| Thrombocytopenia | 3 (4.55) | 6 (9.1) | 6 (9.1) | 2 (3.0) | 17 (25.8) |
| Neutropenia | - | 4 (6.1) | 7 (10.6) | 4 (6.1) | 15 (22.7) |
| Lymphopenia | 1 (1.5) | 3 (4.5) | 3 (4.5) | 3 (4.5) | 10 (15.2) |
| Anemia | 1 (1.5) | 2 (3.0) | 6 (9.1) | 0 | 9 (13.6) |
Abbreviation: AE, adverse effect.