Most frequent adverse events among patients with pulmonary arterial hypertension (PAH) associated with connective tissue disease
| Placebo | Selexipag | |
| Subjects n | 165# | 167 |
| Adverse events n | 1301 | 1499 |
| Patients with at least one adverse event | 160 (97.0) | 164 (98.2) |
| Patients with at least one serious adverse event | 85 (51.5) | 80 (47.9) |
| Patients with adverse event leading to discontinuation of study drug | 15 (9.1) | 32 (19.2) |
| Adverse event¶ | ||
| Headache | 60 (36.4) | 104 (62.3) |
| Diarrhoea | 42 (25.5) | 67 (40.1) |
| Nausea | 41 (24.8) | 62 (37.1) |
| Worsening of PAH | 62 (37.6) | 39 (23.4) |
| Dizziness | 30 (18.2) | 35 (21.0) |
| Vomiting | 10 (6.1) | 34 (20.4) |
| Upper respiratory tract infection | 31 (18.8) | 33 (19.8) |
| Peripheral oedema | 31 (18.8) | 32 (19.2) |
| Pain in extremity | 8 (4.8) | 31 (18.6) |
| Dyspnoea | 37 (22.4) | 30 (18.0) |
| Pain in jaw | 11 (6.7) | 24 (14.4) |
| Myalgia | 10 (6.1) | 21 (12.6) |
| Arthralgia | 12 (7.3) | 19 (11.4) |
| Nasopharyngitis | 12 (7.3) | 19 (11.4) |
| Flushing | 8 (4.8) | 19 (11.4) |
| Cough | 23 (13.9) | 17 (10.2) |
| Chest pain | 15 (9.1) | 17 (10.2) |
| Decreased appetite | 9 (5.5) | 17 (10.2) |
| Anaemia | 17 (10.3) | 16 (9.6) |
Data are presented as n (%), unless otherwise stated. #: among the patients randomly assigned to the placebo group, two did not receive study treatment and were not included in the safety analysis set; ¶: adverse events are listed for those that occurred in more than 10% of the patients in any study group during the double-blind period and up to 7 days after placebo or selexipag was discontinued.