Table 2 Adverse events summary (safety population)
EVO 2.5 mg (N = 35) | EVO 5 mg (N = 36) | EVO 10 mg (N = 36) | SITA 100 mg (N = 39) | |
|---|---|---|---|---|
Subjects with at least 1 AE | ||||
N (%) | 23 (65.7) | 24 (66.7) | 21 (58.3) | 20 (51.3) |
90% CI | 50.5 78.9 | 51.7 79.5 | 43.3 72.3 | 37.1 65.3 |
Discontinuations due to AEs | ||||
N (%) | 2 (5.7) | 1 (2.8) | 0 (0.0) | 1 (2.6) |
Reported AEs | ||||
N | 40 | 49 | 41 | 39 |
AEs relateda to study treatment | ||||
N | 0 | 4 | 0 | 7 |
SAEs | ||||
N | 1 | 1 | 1 | 1 |
Deaths | ||||
N | 0 | 0 | 0 | 0 |