Table 1.
Adverse events reported during the GRIPHON clinical trial
Placebo (n=577) (%) |
Selexipag (n=575) (%) |
P-value | |
---|---|---|---|
Headache | 189 (33) | 375 (65) | <0.001 |
Diarrhea | 110 (19) | 244 (42) | <0.001 |
Nausea | 107 (19) | 193 (34) | <0.001 |
Pain in jaw | 36 (6) | 148 (26) | <0.001 |
Worsening of PAH | 206 (36) | 126 (22) | <0.001 |
Vomiting | 49 (9) | 104 (18) | <0.001 |
Pain in extremity | 46 (8) | 97 (17) | <0.001 |
Dyspnea | 121 (21) | 92 (16) | 0.03 |
Myalgia | 34 (6) | 92 (16) | <0.001 |
Dizziness | 85 (15) | 86 (15) | 0.96 |
Peripheral edema | 104 (18) | 80 (14) | 0.06 |
Notes: Events reported by ≥15% in either group are listed. From N Engl J Med, Sitbon O, Channick R, Chin KM, et al, Selexipag for the treatment of pulmonary arterial hypertension, 373, 2522–2533. Copyright © (2015) Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society.29
Abbreviation: PAH, pulmonary arterial hypertension.