AE | Treatment Set (N = 88) |
---|---|
Any AE | 88 (100) |
Leading to dose reduction | 49 (56) |
Leading to discontinuation | 8 (9) |
SAE | 37 (42) |
Fatal | 7 (8) |
Immediately-life threatening | 1 (1) |
Disability incapacity | 0 |
Requiring hospitalization | 37 (42) |
Prolonging hospitalization | 3 (3) |
Congenital anomaly | 0 |
Other | 2 (2) |
Highest CTCAE grade | |
Grade 1 | 2 (2) |
Grade 2 | 22 (25) |
Grade 3 | 55 (63) |
Grade 4 | 2 (2) |
Grade 5 | 7 (8) |