Most common all-cause AEs
| AE, n (%) . | Total ITT cohort (N = 64) . | ||
|---|---|---|---|
| All grade (≥25%) . | Grade ≥3 (≥15%) . | SAEs (>10%) . | |
| Constipation | 31 (48) | 1 (2) | 0 |
| Fatigue | 27 (42) | 2 (3) | 0 |
| Nausea | 27 (42) | 0 | 0 |
| Anemia | 25 (39) | 19 (30) | 1 (2) |
| Decreased appetite | 19 (30) | 0 | 0 |
| Febrile neutropenia | 19 (30) | 19 (30) | 16 (25) |
| Pyrexia | 16 (25) | 2 (3) | 4 (6) |
| Thrombocytopenia | 18 (28) | 15 (23) | 1 (2) |
| Neutropenia | 15 (23) | 13 (20) | 0 |
| Vomiting | 15 (23) | 0 | 0 |
| Pneumonia | 14 (22) | 11 (17) | 9 (14) |
| AE, n (%) . | Total ITT cohort (N = 64) . | ||
|---|---|---|---|
| All grade (≥25%) . | Grade ≥3 (≥15%) . | SAEs (>10%) . | |
| Constipation | 31 (48) | 1 (2) | 0 |
| Fatigue | 27 (42) | 2 (3) | 0 |
| Nausea | 27 (42) | 0 | 0 |
| Anemia | 25 (39) | 19 (30) | 1 (2) |
| Decreased appetite | 19 (30) | 0 | 0 |
| Febrile neutropenia | 19 (30) | 19 (30) | 16 (25) |
| Pyrexia | 16 (25) | 2 (3) | 4 (6) |
| Thrombocytopenia | 18 (28) | 15 (23) | 1 (2) |
| Neutropenia | 15 (23) | 13 (20) | 0 |
| Vomiting | 15 (23) | 0 | 0 |
| Pneumonia | 14 (22) | 11 (17) | 9 (14) |