Table 2.
Most frequent (≥10% of patients) treatment-emergent adverse events of any grade in the safety population
| TEAE | Overall (N = 97) | |
|---|---|---|
| Any grade, n (%) | Grade ≥3, n (%) | |
| Asthenia/fatigue | 56 (57.7) | 8 (8.2) |
| Nausea | 41 (42.3) | 1 (1.0) |
| Anemiaa | 35 (36.1) | 20 (20.6) |
| Decreased appetite | 28 (28.9) | 2 (2.1) |
| Thrombocytopeniab | 22 (22.7) | 11 (11.3) |
| Vomiting | 22 (22.7) | 1 (1.0) |
| Blood creatinine increased | 21 (21.6) | 1 (1.0) |
| Constipation | 21 (21.6) | 3 (3.1) |
| ALT/AST increased | 17 (17.5) | 5 (5.2) |
| Dysgeusia | 16 (16.5) | 0 |
| Dyspnea | 13 (13.4) | 3 (3.1) |
| Weight decreased | 13 (13.4) | 0 |
| Diarrhea | 12 (12.4) | 1 (1.0) |
| Urinary tract infection | 12 (12.4) | 4 (4.1) |
| Abdominal pain | 11 (11.3) | 1 (1.0) |
| Hypophosphatemia | 10 (10.3) | 5 (5.2) |
| Dehydration | 10 (10.3) | 2 (2.1) |
| Insomnia | 10 (10.3) | 0 |
| Pyrexia | 10 (10.3) | 1 (1.0) |
ALT alanine aminotransferase; AST aspartate aminotransferase; TEAE treatment-emergent adverse event.
Visit cutoff date: February 20, 2020.
a Combined term for anemia or decreased hemoglobin.
b Combined term for thrombocytopenia or decreased platelets.