Table 2.
Overview of AEs (Safety-Evaluable Population)
| Placebo (N = 47) | Vicasinabin 30 mg (N = 48) | Vicasinabin 200 mg (N = 43) | All Participants (N = 139) | |
|---|---|---|---|---|
| Total number of AEs | 102 | 110 | 97 | 309 |
| Total number of participants with at ≥1: | ||||
| AE | 34 (72.3%) | 31 (64.6%) | 35 (81.4%) | 100 (72.5%) |
| AE with fatal outcome | 1 (2.1%) | 0 | 0 | 1 (0.7%) |
| Serious AE | 8 (17.0%) | 3 (6.3%) | 5 (11.6%) | 16 (11.6%) |
| Related serious AE | 0 | 0 | 0 | 0 |
| Serious ocular AE | 1 (2.1%) | 2 (4.2%) | 1 (2.3%) | 4 (2.9%) |
| Serious systemic AE | 7 (14.9%) | 1 (2.1%) | 4 (9.3%) | 12 (8.7%) |
| Serious AE leading to withdrawal from treatment | 3 (6.4%) | 0 | 0 | 3 (2.2%) |
AE = adverse event.