Treatment-emergent adverse events* (SAF; n=451)
| Preferred term | Total (n=451) | |||
| Grade 1–2 | Grade 3 | Grade 4 | Grade 5 | |
| Fatigue | 120 (26.6) | 8 (1.8) | 0 | 0 |
| Nausea | 106 (23.5) | 6 (1.3) | 0 | 0 |
| Decreased appetite | 92 (20.4) | 0 | 0 | 0 |
| Constipation | 76 (16.9) | 3 (0.7) | 0 | 0 |
| Diarrhea | 75 (16.4) | 8 (1.8) | 0 | 0 |
| Abdominal pain | 62 (13.7) | 7 (1.6) | 0 | 0 |
| Cough | 62 (13.7) | 0 | 0 | 0 |
| Back pain | 61 (13.5) | 6 (1.3) | 0 | 0 |
| Rash | 60 (13.3) | 1 (0.2) | 0 | 0 |
| Vomiting | 58 (12.9) | 8 (1.8) | 0 | 0 |
| Dyspnea | 43 (9.5) | 2 (0.4) | 0 | 0 |
| Weight decreased | 37 (8.2) | 3 (0.7) | 0 | 0 |
| Hypercalcemia | 19 (4.2) | 3 (0.7) | 0 | 0 |
| Anemia | 19 (4.2) | 22 (4.9) | 0 | 0 |
| Increased ALT | 17 (3.8) | 8 (1.8) | 0 | 0 |
| Increased AST | 16 (3.5) | 7 (1.5) | 0 | 0 |
| Lower respiratory tract infection | 12 (2.7) | 3 (0.7) | 0 | 0 |
| Hypokalemia | 12 (2.7) | 8 (1.8) | 1 (0.2) | 0 |
| Dysphagia | 9 (2.0) | 7 (1.6) | 0 | 0 |
| Pneumonia | 7 (1.6) | 20 (4.4) | 0 | 3 (0.7) |
| Pleural effusion | 7 (1.6) | 5 (1.1) | 0 | 1 (0.2) |
| Pneumonitis | 6 (1.3) | 6 (1.3) | 0 | 1 (0.2) |
| Hypertension | 6 (1.3) | 6 (1.3) | 0 | 0 |
| Ascites | 6 (1.3) | 7 (1.6) | 0 | 0 |
| Hyponatremia | 5 (1.1) | 3 (0.7) | 0 | 0 |
| Increased blood bilirubin | 4 (0.9) | 2 (0.4) | 1 (0.2) | 0 |
| Colitis | 3 (0.7) | 3 (0.7) | 0 | 0 |
| Hyperglycemia | 1 (0.2) | 4 (0.9) | 1 (0.2) | 0 |
| Pulmonary embolism | 0 | 5 (1.1) | 0 | 0 |
| Upper gastrointestinal hemorrhage | 0 | 4 (0.9) | 0 | 0 |
| Small intestinal obstruction | 0 | 3 (0.7) | 0 | 0 |
| Sepsis | 0 | 1 (0.2) | 2 (0.4) | 1 (0.2) |
Data presented as n (%).
*This table shows all grade 1 or 2 adverse events occurring in ≥10% of patients and grade 3–5 events occurring in three or more patients.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; SAF, safety analysis set.