Table 3 Adverse events
Adverse events (AEs)a | Placebo (n = 53) | Sildenafil (n = 50) | ||
|---|---|---|---|---|
All causality | Treatment related | All causality | Treatment related | |
Patients with AEs, n (%) | 41 (77) | 13 (25) | 34 (68) | 17 (34) |
Patients with serious AEs, n (%) | 12 (23) | 0 | 9 (18) | 1 (2) |
AEs | ||||
Headache | 5 (9) | 3 (6) | 6 (12) | 6 (12) |
Flushing | 1 (2) | 1 (2) | 5 (10) | 5 (10) |
Diarrhoea | 3 (6) | 1 (2) | 5 (10) | 3 (6) |
Nasopharyngitis | 5 (9) | 0 | 4 (8) | 0 |
Vertigo | 0 | 0 | 3 (6) | 0 |
Vision blurred | 0 | 0 | 3 (6) | 2 (4) |
Oedema, peripheral | 2 (4) | 1 (2) | 3 (6) | 1 (2) |
Pulmonary arterial hypertension | 5 (9) | 0 | 2 (4) | 0 |
Back pain | 4 (8) | 0 | 1 (2) | 0 |
Bronchitis | 4 (8) | 0 | 1 (2) | 0 |
Upper respiratory tract infection | 3 (6) | 0 | 1 (2) | 0 |
Nausea | 4 (8) | 2 (4) | 0 | 0 |