Prostacyclin (PGI2)-associated adverse events reported in the study titration and maintenance periods among patients with pulmonary arterial hypertension associated with connective tissue disease
| Titration period | Maintenance period | |||
| Placebo | Selexipag | Placebo | Selexipag | |
| Subjects n | 165# | 167 | 142 | 142 |
| Patients with at least one PGI2-associated adverse event | 107 (64.8) | 143 (85.6) | 73 (51.4) | 103 (72.5) |
| Adverse event | ||||
| Headache | 56 (33.9) | 100 (59.9) | 26 (18.3) | 55 (38.7) |
| Diarrhoea | 29 (17.6) | 54 (32.3) | 23 (16.2) | 38 (26.8) |
| Nausea | 33 (20.0) | 53 (31.7) | 18 (12.7) | 31 (21.8) |
| Vomiting | 7 (4.2) | 28 (16.8) | 4 (2.8) | 15 (10.6) |
| Pain in extremity | 6 (3.6) | 27 (16.2) | 4 (2.8) | 18 (12.7) |
| Pain in jaw | 7 (4.2) | 22 (13.2) | 6 (4.2) | 19 (13.4) |
| Dizziness | 18 (10.9) | 20 (12.0) | 22 (15.5) | 21 (14.8) |
| Myalgia | 7 (4.2) | 20 (12.0) | 5 (3.5) | 10 (7.0) |
| Flushing | 7 (4.2) | 15 (9.0) | 3 (2.1) | 12 (8.5) |
| Arthralgia | 10 (6.1) | 11 (6.6) | 4 (2.8) | 15 (10.6) |
| Musculoskeletal pain | 3 (1.8) | 7 (4.2) | 5 (3.5) | 5 (3.5) |
Data are presented as n (%), unless otherwise stated. A patient with multiple occurrences of an adverse event during one treatment period is counted only once in the adverse event category for that treatment and period. #: among the patients randomly assigned to the placebo group, two did not receive study treatment and were not included in the safety analysis set.