Exposure and safety
| Pooled selexipag | Pooled control | |
| 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) |
AE: adverse event; PAH: pulmonary arterial hypertension. #: calculated based on the number of AEs; includes AEs with a frequency of ≥1% in either group.