Table 3.
Safety and exposure
| Selexipag treated patients, (n = 953) | |
|---|---|
| Selexipag exposure, months, median (range) | 31.7 (0.0–106.0) |
| Adverse events, n (%) | |
| Patients with ≥ 1 adverse event | 949 (99.6) |
| Patients with ≥ 1 serious adverse event | 573 (60.1) |
| Patients with ≥ 1 adverse event leading to selexipag discontinuationa | 305 (32.0) |
| Most frequentb adverse events | n (%) | Incidence rate per year per 100 treated patients |
|---|---|---|
| Headache | 647 (67.9) | 66.3 |
| Diarrhoea | 425 (44.6) | 23.0 |
| Nausea | 313 (32.8) | 14.3 |
| PAH worsening | 311 (32.6) | 11.9 |
| Pain in jaw | 268 (28.1) | 12.0 |
| Pain in extremity | 175 (18.4) | 6.7 |
| Vomiting | 174 (18.3) | 6.8 |
| Dyspnoea | 172 (18.0) | 6.4 |
| Oedema peripheral | 159 (16.7) | 5.8 |
| Myalgia | 157 (16.5) | 6.1 |
| Dizziness | 156 (16.4) | 5.9 |
| Nasopharyngitis | 149 (15.6) | 5.6 |
| Right ventricular failure | 147 (15.4) | 5.1 |
| Upper respiratory tract infection | 136 (14.3) | 5.1 |
| Cough | 130 (13.6) | 4.8 |
| Arthralgia | 119 (12.5) | 4.4 |
| Flushing | 117 (12.3) | 4.4 |
| Anaemia | 108 (11.3) | 3.9 |
| Bronchitis | 100 (10.5) | 3.6 |
Data presented for the safety/tolerability set
PAH pulmonary arterial hypertension
aAll adverse events leading to discontinuation of selexipag are reported here and not only those considered the primary reason for discontinuation as presented in Table 1
bOccurring in ≥ 10% of patients