Table 2.
Treatment-emergent AEs
| AEs | All treated patients (n = 159), n (%) | |
|---|---|---|
| Any grade | Grade 3/4 | |
| Most common AEs* | ||
| Diarrhea | 99 (62) | 5 (3) |
| Nausea | 68 (43) | 2 (1) |
| Neutropenia | 66 (42) | 52 (33) |
| Arthralgia | 53 (33) | 2 (1) |
| Hypertension | 25 (16) | 9 (6) |
| Neutrophil count decreased | 16 (10) | 8 (5) |
| Other AEs of clinical interest | ||
| Atrial fibrillation | 7 (4) | 2 (1) |
| Major hemorrhage† | 3 (2) | 2 (1) |
| Laboratory safety parameters | ||
| Hematology | ||
| Neutrophils decreased | 115 (72) | 60 (38) |
| Platelets decreased | 94 (59) | 20 (13) |
| Hemoglobin decreased | 31 (19) | 0 |
| Chemistry | ||
| Corrected calcium decreased | 61 (38) | 1 (1) |
| Potassium increased | 39 (25) | 4 (3) |
| Uric acid increased | 34 (21) | 34 (21) |
| Creatinine increased | 27 (17) | 0 |
*
AEs of any grade occurring in ≥30% of patients or grade 3/4 occurring in ≥5% of patients.
†
Major hemorrhage was identified using the Standardized MedDRA Query for Hemorrhage, excluding laboratory terms.