1 mg/kg (n = 15) | 3 mg/kg (n = 15) | 10 mg/kg (n = 6) | Total (n = 36) | |||||
---|---|---|---|---|---|---|---|---|
Case | N (%) | Case | N (%) | Case | N (%) | Case | N (%) | |
Total TRAE | 398 | 15 (100.00) | 295 | 15 (100.00) | 96 | 6 (100.00) | 789 | 36 (100.00%) |
TRAE ≥ grade 3 | 8 | 5 (33.33) | 10 | 5 (33.33) | 7 | 3 (50.00) | 25 | 13 (36.11%) |
Termination due to TRAE | 0 | 0 (0.00) | 0 | 0 (0.00) | 0 | 0 (0.00) | 0 | 0 (0.00%) |
Pause due to TRAE | 2 | 2 (13.33) | 3 | 3 (20.00) | 1 | 1 (16.67) | 6 | 6 (16.67%) |
Treatment-related SAE | 3 | 2 (13.33) | 1 | 1 (6.67) | 3 | 2 (33.33) | 7 | 5 (13.89%) |
TRAE/SAE leading to death | 0 | 0 (0.00) | 0 | 0 (0.00) | 2 | 2 (33.33) | 2 | 2 (5.56%) |