Safety of RO7283420 in the overall population and by group and mode of administration
AE, n (%) . | Overall population (N = 62) . | Group I, IV administration (n = 51) . | Group I, SC administration (n = 6) . | Group II, IV administration (n = 5) . |
---|---|---|---|---|
Any AE | 61 (98.4) | 50 (98) | 6 (100) | 5 (100) |
Any treatment-related AE∗ | 51 (82.3) | 42 (82.4) | 5 (83.3) | 4 (80) |
Grade 3 AE | 46 (74.2) | 41 (80.4) | 3 (50) | 2 (40) |
Grade 3 treatment-related AE∗ | 13 (21) | 11 (21.6) | 1 (16.7) | 1 (20) |
Grade 4 AE | 10 (16.1) | 6 (11.8) | 3 (50) | 1 (20) |
Grade 4 treatment-related AE∗ | 3 (4.8) | 1 (2) | 1 (16.7) | 1 (20) |
Deaths | 49 (79) | 44 (86.3) | 4 (66.7) | 1 (20) |
Grade 5 AE | 12 (19.4) | 11 (21.6) | 1 (16.7) | 0 |
Grade 5 treatment-related AE∗ | 1 (1.6) | 1 (2) | 0 | 0 |
Serious AE | 48 (77.4) | 42 (82.4) | 4 (66.7) | 2 (40) |
Serious treatment-related AE∗ | 25 (40.3) | 21 (41.2) | 3 (50) | 1 (20) |
Event that qualifies as DLT | 11 (17.7) | 8 (15.7) | 2 (33.3) | 1 (20) |
AE, n (%) . | Overall population (N = 62) . | Group I, IV administration (n = 51) . | Group I, SC administration (n = 6) . | Group II, IV administration (n = 5) . |
---|---|---|---|---|
Any AE | 61 (98.4) | 50 (98) | 6 (100) | 5 (100) |
Any treatment-related AE∗ | 51 (82.3) | 42 (82.4) | 5 (83.3) | 4 (80) |
Grade 3 AE | 46 (74.2) | 41 (80.4) | 3 (50) | 2 (40) |
Grade 3 treatment-related AE∗ | 13 (21) | 11 (21.6) | 1 (16.7) | 1 (20) |
Grade 4 AE | 10 (16.1) | 6 (11.8) | 3 (50) | 1 (20) |
Grade 4 treatment-related AE∗ | 3 (4.8) | 1 (2) | 1 (16.7) | 1 (20) |
Deaths | 49 (79) | 44 (86.3) | 4 (66.7) | 1 (20) |
Grade 5 AE | 12 (19.4) | 11 (21.6) | 1 (16.7) | 0 |
Grade 5 treatment-related AE∗ | 1 (1.6) | 1 (2) | 0 | 0 |
Serious AE | 48 (77.4) | 42 (82.4) | 4 (66.7) | 2 (40) |
Serious treatment-related AE∗ | 25 (40.3) | 21 (41.2) | 3 (50) | 1 (20) |
Event that qualifies as DLT | 11 (17.7) | 8 (15.7) | 2 (33.3) | 1 (20) |
Considered by the investigator to be related to RO7283420. AE, adverse event; DLT, dose-limiting toxicity; IV, intravenous; SC, subcutaneous.