TABLE 2.
Placebo (N = 6) | Selnoflast (N = 13) | All patients (N = 19) | |
---|---|---|---|
Patients with at least one adverse event (AE) | 1 (16.7%) | 10 (76.9%) | 11 (57.9%) |
Total AEs | 1 | 12 | 13 |
Deaths | 0 | 0 | 0 |
Patients withdrawn from study due to AE | 0 | 0 | 0 |
Patients with at least one | |||
AE with fatal outcome | 0 | 0 | 0 |
Serious AE | 0 | 0 | 0 |
AE leading to withdrawal from treatment | 0 | 0 | 0 |
AE leading to dose modification/interruption | 0 | 0 | 0 |
Related AE | 1 (16.7%) | 3 (23.1%) | 4 (21.1%) |
Related AE leading to withdrawal from treatment | 0 | 0 | 0 |
Related AE leading to dose modification/ interruption | 0 | 0 | 0 |