Table 5.
Prostacyclin‐associated adverse events reported in the study titration and maintenance periods for patients with pulmonary arterial hypertension associated with congenital heart disease after defect correction
| Titration period | Maintenance period | |||
|---|---|---|---|---|
| Placebo (n = 50) | Selexipag (n = 60) | Placeboa (n = 46) | Selexipaga (n = 59) | |
| Exposure to double‐blind treatment, weeks, median (range) | 12.4 (0.7–12.4) | 12.4 (2.3–12.4) | 73.4 (2.9–166.6) | 64.6 (1.9–152.4) |
| Patients with ≥ 1 prostacyclin‐associated AE, n (%) | 24 (48.0) | 53 (88.3) | 14 (30.4) | 41 (69.5) |
| AE, n (%) | ||||
| Headache | 17 (34.0) | 40 (66.7) | 8 (17.4) | 25 (42.4) |
| Diarrhoea | 1 (2.0) | 18 (30.0) | 1 (2.2) | 13 (22.0) |
| Myalgia | 4 (8.0) | 17 (28.3) | 3 (6.5) | 12 (20.3) |
| Pain in jaw | 1 (2.0) | 17 (28.3) | 2 (4.3) | 13 (22.0) |
| Nausea | 1 (2.0) | 15 (25.0) | – | 9 (15.3) |
| Arthralgia | – | 9 (15.0) | – | 8 (13.6) |
| Flushing | 2 (4.0) | 7 (11.7) | 1 (2.2) | 5 (8.5) |
| Pain in extremity | 4 (8.0) | 5 (8.3) | 3 (6.5) | 6 (10.2) |
| Vomiting | – | 5 (8.3) | – | 3 (5.1) |
| Dizziness | 1 (2.0) | 3 (5.0) | 1 (2.2) | 5 (8.5) |
| Temporomandibular joint syndrome | – | 2 (3.3) | – | 2 (3.4) |
AE, adverse event.
A patient with multiple occurrences of an AE during one treatment period is counted only once in the AE category for that treatment and period.
a
Among the patients randomly assigned to each treatment arm, 4 in the placebo group and 1 in the selexipag group did not receive study treatment in the maintenance phase.