Table 2. Distribution of adverse events by frequency and treatment arm.
WA-ref: weight adjusted reference group (200 μg/kg), FD18: fixed-dose 18 mg, FD36: fixed-dose 36 mg).
| Treatment | ||||||
|---|---|---|---|---|---|---|
| Before treatment (N = 57) | WA-ref (N = 54) |
FD18 (N = 55) |
FD36 (N = 57) |
Total (N = 57) |
||
| All reported adverse events | 1 (1.8%) 1 | 10 (18.5%) 11 | 9 (16.4%) 9 | 13 (22.8%) 13 | 23(40.4%) 34 | |
| Treatment-emergent adverse events (TEAEs) | n.a. | 10 (18.5%) 11 | 9 (16.4%) 9 | 13 (22.8%) 13 | 22 (38.6%) 33 | |
| Relationship | Study-drug related TEAEs | n.a. | 7 (13.0%) 8 | 2 (3.6%) 2 | 5 (8.8%) 5 | 9 (15.8%) 15 |
| Not study-drug related TEAEs | n.a. | 3 (5.6%) 3 | 7 (12.7%) 7 | 8 (14.0%) 8 | 17 (29.8%) 18 | |
| Severity | Mild AEs | 1 (1.8%) 1 | 3 (5.5%) 4 | 2 (3.6%) 2 | 4 (7.0%) 4 | 10 (17.5%) 11 |
| Mild TEAEs | n.a. | 3 (5.5%) 4 | 2 (3.6%) 2 | 4 (7.0%) 4 | 9 (15.8%) 10 | |
| Moderate TEAEs | n.a. | 7 (13.0%) 7 | 7 (12.7%) 7 | 9 (15.8%) 9 | 23 (40.4%) 23 | |
| AEs requiring therapy | 1 (1.8%) 1 | 7 (13.0%) 7 | 7 (12.7%) 7 | 7 (12.3%) 7 | 14 (24.6%) 22 | |
| Serious TEAEs (SAEs) | n.a. | 0 (0) 0 | 0 (0) 0 | 0 (0) 0 | 0 (0) 0 | |
| TEAEs leading to dose withdrawal | n.a. | 0 (0) 0 | 0 (0) 0 | 1 (1.8%) 0 | 1 (1.8%) 1 | |