Treatment emergent AEs
| DB phase,% of patients | OLE phase,% of patients | ||
|---|---|---|---|
| Placebo (n = 113) | Sildenafil (n = 104) | Sildenafil (n = 206) | |
| *AEs occurring in ⩾3% patients of either treatment group; †may include MS relapse not specified as such. | |||
| AE, adverse event; DB, double blind; MS, multiple sclerosis; OLE, open label extension. | |||
| Patients with AEs of all | 43.4 | 66.3 | 73 |
| causalities | |||
| Patients with treatment | 6.2 | 42.3 | 41 |
| related AEs | |||
| Patients with serious AEs | 2.7 | 2.9 | 6 |
| Patients with severe AEs | 3.5 | 9.6 | 10 |
| Patients discontinued due | 0.9 | 0 | 2 |
| to AEs | |||
| Most common AEs, all | |||
| causality* (treatment related) | |||
| Headache | 7 (4) | 27 (21) | 23 (19) |
| Flushing | 2 (2) | 13 (13) | 16 (15) |
| Weakness† | 1 (0) | 6 (0) | 4 (0) |
| MS relapse | 2 (0) | 7 (0) | 10 (0) |
| Rhinitis | 1 (0) | 6 (4) | 7 (2) |
| Chromatopsia | 0 | 4 (4) | 4 (4) |
| Dyspepsia | 0 | 6 (3) | 6 (4) |