Table 3.
Grade ≥3 TEAEs reported by ≥10% of patients (safety analysis set)
| TEAE, n (%) | Dose, μg/kg | |||||||
|---|---|---|---|---|---|---|---|---|
| Q3W | QW | Total (N = 35) | ||||||
| 15 (n = 5) | 30 (n = 7) | 60 (n = 3) | 90 (n = 4) | 120 (n = 5) | 150 (n = 6) | 50 (n = 5) | ||
| Any | 5 (100) | 4 (57.1) | 3 (100) | 3 (75.0) | 5 (100) | 6 (100) | 4 (80.0) | 30 (85.7) |
| Febrile neutropenia | 0 (0) | 1 (14.3) | 1 (33.3) | 2 (50.0) | 2 (40.0) | 3 (50.0) | 1 (20.0) | 10 (28.6) |
| AST increased | 0 (0) | 0 (0) | 0 (0) | 2 (50.0) | 1 (20.0) | 2 (33.3) | 1 (20.0) | 6 (17.1) |
| Blood bilirubin increased | 0 (0) | 0 (0) | 1 (33.3) | 0 (0) | 1 (20.0) | 2 (33.3) | 1 (20.0) | 5 (14.3) |
| GGT increased | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 3 (60.0) | 1 (16.7) | 1 (20.0) | 5 (14.3) |
| Abdominal pain | 0 (0) | 1 (14.3) | 0 (0) | 1 (25.0) | 0 (0) | 1 (16.7) | 1 (20.0) | 4 (11.4) |
| Anemia | 0 (0) | 1 (14.3) | 1 (33.3) | 1 (25.0) | 0 (0) | 0 (0) | 1 (20.0) | 4 (11.4) |
| Bacteremia | 0 (0) | 0 (0) | 0 (0) | 2 (50.0) | 0 (0) | 1 (16.7) | 1 (20.0) | 4 (11.4) |
| Neutrophil count decreased | 0 (0) | 2 (28.6) | 0 (0) | 0 (0) | 1 (20.0) | 1 (16.7) | 0 (0) | 4 (11.4) |
| Sepsis | 0 (0) | 2 (28.6) | 0 (0) | 0 (0) | 1 (20.0) | 0 (0) | 1 (20.0) | 4 (11.4) |