Table 4.
Adverse events (AEs) and serious adverse events (SAEs).a
| Patients, n (%) (N=400) | |
|---|---|
| All AEs | 249 (62.3) |
| Suspected relationship to study drug | 52 (13.0) |
| Led to dose adjustment or temporary treatment interruption | 4 (1.0) |
| Led to discontinuation | 16 (4.0) |
| Required concomitant medication/nondrug therapy | 155 (38.8) |
| SAEs | 75 (18.8) |
| Death | 17 (4.3) |
| SAEs with suspected relationship to study drug | 4 (1.0) |
| SAEs leading to discontinuation | 10 (2.5) |
| Frequent AEs (≥ 2.8%; by preferred term) | |
| Bone pain | 45 (11.3) |
| Nausea | 33 (8.3) |
| Fatigue | 25 (6.3) |
| Back pain | 19 (4.8) |
| Constipation | 18 (4.5) |
| Vomiting | 18 (4.5) |
| Chills | 18 (4.5) |
| Pain in extremity | 18 (4.5) |
| Pyrexia | 16 (4.0) |
| Diarrhea | 14 (3.5) |
| Tumor pain | 12 (3.0) |
| Anemia | 11 (2.8) |
| Arthralgia | 11 (2.8) |
| Malignant neoplasm progression | 11 (2.8) |
| Cough | 11 (2.8) |
a
Safety population includes all enrolled patients who received at least one dose of study drug.