Table 2.
Patients with NEs, n (%) | Original evaluation cohort (N = 189) | Additional evaluation cohort (N = 36) |
---|---|---|
Any NE | 98 (52) | 15 (42) |
Grade ≥ 3 NEs | 24 (13) | 6 (17) |
Grade 3 | 20 (11) | 4 (11) |
Grade 4 | 4 (2) | 0 |
Grade 5 | 0 | 2 (6) |
Serious NEs | 31 (16) | 7 (19) |
Any treatment-related NE | 66 (35) | 11 (31) |
Treatment-related grade ≥ 3 NEs | 22 (12) | 4 (11) |
Grade 3 | 18 (10) | 3 (8) |
Grade 4 | 4 (2) | 0 |
Grade 5 | 0 | 1 (3) |
Serious treatment-related NEs | 27 (14) | 5 (14) |
NEs leading to dose interruption | 29 (15) | 5 (14) |
NEs leading to permanent discontinuation | 9 (5) | 3 (8) |
NE neurologic event