Table 3.
Summary of AEsa
| Placebo (n = 38) | Selexipag (n = 36) | |
|---|---|---|
| Patients with AEs | 33 (86.8) | 36 (100.0) |
| Patients with SAEs | 4 (10.5) | 2 (5.6) |
| Patients with AEs leading to study drug discontinuation | 2 (5.3) | 6 (16.7)b |
| AEs occurring in ≥10% of patients in either treatment group | ||
| Headache | 14 (36.8) | 23 (63.9) |
| Nausea | 4 (10.5) | 13 (36.1) |
| Diarrhea | 5 (13.2) | 10 (27.8) |
| Dizziness | 2 (5.3) | 8 (22.2) |
| Pain in extremity | 2 (5.3) | 8 (22.2) |
| Pain in jaw | 0 (0.0) | 8 (22.2) |
| Fatigue | 3 (7.9) | 6 (16.7) |
| Myalgia | 2 (5.3) | 5 (13.9) |
| Arthralgia | 1 (2.6) | 5 (13.9) |
| Nasopharyngitis | 6 (15.8) | 4 (11.1) |
| Flushing | 1 (2.6) | 4 (11.1) |
| Back pain | 0 (0.0) | 4 (11.1) |
| Raynaud's phenomenon worsening | 4 (10.5) | 2 (5.6) |
| Abdominal pain, upper | 4 (10.5) | 1 (2.8) |
| Skin ulcer | 5 (13.2) | 0 (0.0) |
a
Safety analysis set for the double‐blind treatment period. Values are the number (%). SAEs = serious adverse events.
b
Includes 1 patient who discontinued due to an AE (headache) with onset during the run‐in period.