Patients n | 329 | 320 |
Exposure to study treatment months, median (min, max) | 16.7 (0.1, 42.0) | 13.4 (0.1, 43.2) |
AEs, n (%) | | |
Patients with ≥1 AE | 323 (98.2) | 307 (95.9) |
Patients with ≥1 serious AE | 140 (42.6) | 129 (40.3) |
Patients with ≥1 AE leading to discontinuation of double-blind study treatment | 85 (25.8) | 100 (31.3) |
Number of AEs | 2836 | 2259 |
Most frequent AEs, n (%)# | | |
Headache | 208 (7.3) | 126 (5.5) |
Diarrhoea | 130 (4.6) | 64 (2.8) |
Nausea | 105 (3.7) | 51 (2.2) |
Peripheral oedema | 79 (2.8) | 76 (3.3) |
Pain in jaw | 68 (2.4) | 20 (0.9) |
Pain in extremity | 65 (2.3) | 24 (1.1) |
Vomiting | 62 (2.2) | 29 (1.3) |
PAH worsening | 53 (1.9) | 94 (4.1) |
Dyspnoea | 49 (1.7) | 61 (2.7) |
Myalgia | 48 (1.7) | 33 (1.5) |
Arthralgia | 44 (1.5) | 29 (1.3) |
Dizziness | 41 (1.4) | 47 (2.1) |
Nasopharyngitis | 40 (1.4) | 34 (1.5) |
Flushing | 38 (1.3) | 26 (1.1) |
Cough | 34 (1.2) | 37 (1.6) |
Upper respiratory tract infection | 33 (1.2) | 46 (2.0) |
Fatigue | 32 (1.1) | 33 (1.5) |
Dyspepsia | 32 (1.1) | 18 (0.8) |
Anaemia | 31 (1.1) | 21 (0.9) |
Back pain | 23 (0.8) | 24 (1.1) |
Nasal congestion | 22 (0.8) | 24 (1.1) |
Right ventricular failure | 18 (0.6) | 26 (1.1) |
Gastroesophageal reflux disease | 16 (0.6) | 22 (1.0) |