Table 2 Safety summary in the as-treated population
Event, n (%)a | Q3W (mg/kg) | Q2W (mg/kg) | QW × 2 (mg/kg) | QW × 4 (mg/kg) | Total | |||||
|---|---|---|---|---|---|---|---|---|---|---|
Cohort 1 0.1 n = 5 (%) | Cohort 2 0.5 n = 5 (%) | Cohort 3 2.5 n = 3 (%) | Cohort 4 10 n = 6 (%) | Cohort 5 20 n = 9 (%) | Cohort 6 10 n = 4 (%) | Cohort 7 20 n = 18 (%) | Cohort 8 20 n = 3 (%) | Cohort 9 20 n = 5 (%) | N = 58 (%) | |
Any AE | 5 (100) | 5 (100) | 3 (100) | 6 (100) | 9 (100) | 4 (100) | 18 (100) | 3 (100) | 5 (100) | 58 (100) |
Any grade ≥ 3 AE | 2 (40) | 5 (100) | 1 (33) | 5 (83) | 6 (67) | 2 (50) | 11 (61) | 1 (33) | 1 (20) | 34 (59) |
Any death (grade 5 AE) | 1 (20) | 0 | 0 | 1 (17) | 0 | 0 | 2 (11) | 0 | 0 | 4 (7) |
Serious AE | 2 (40) | 4 (80) | 0 | 3 (50) | 5 (56) | 1 (25) | 10 (56) | 1 (33) | 2 (40) | 28 (48) |
AE leading to discontinuation | 1 (20) | 2 (40) | 0 | 1 (17) | 2 (22) | 0 | 2 (11) | 0 | 0 | 8 (14) |
Treatment-related AE | 5 (100) | 4 (80) | 3 (100) | 5 (83) | 5 (56) | 4 (100) | 15 (83) | 3 (100) | 4 (80) | 48 (83) |
Treatment-related grade ≥ 3 AE | 0 | 3 (60) | 0 | 0 | 2 (22) | 0 | 6 (33) | 0 | 1 (20) | 12 (21) |
Treatment-related death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Treatment-related serious AE | 0 | 1 (20) | 0 | 1 (17) | 1 (11) | 1 (25) | 3 (17) | 0 | 1 (20) | 8 (14) |
Treatment-related AE leading to discontinuation | 0 | 2 (40) | 0 | 1 (17) | 1 (11) | 0 | 0 | 0 | 0 | 4 (7) |