Adverse event, n (%) | Placebo (n=12) | Riociguat 2.5 mg–maximum (n=15) | Riociguat 1.5 mg–maximum (n=8) |
---|---|---|---|
Any adverse event | 10 (83) | 14 (93) | 6 (75) |
Adverse events occurring in ≥10% of patients in any treatment group | |||
Dyspepsia | 0 | 4 (27) | 0 |
Headache | 2 (17) | 4 (27) | 2 (25) |
Dizziness | 2 (17) | 3 (20) | 2 (25) |
Abdominal pain | 0 | 2 (13) | 0 |
Anaemia | 0 | 2 (13) | 1 (13) |
Epistaxis | 0 | 2 (13) | 0 |
Hypotension | 0 | 2 (13) | 0 |
Nasopharyngitis | 1 (8) | 2 (13) | 0 |
Palpitations | 2 (17) | 2 (13) | 0 |
Peripheral oedema | 1 (8) | 2 (13) | 1 (13) |
Back pain | 2 (17) | 1 (7) | 0 |
Face oedema | 1 (8) | 1 (7) | 1 (13) |
Hiccups | 0 | 1 (7) | 1 (13) |
Hypokalaemia | 0 | 1 (7) | 1 (13) |
Anxiety | 1 (8) | 0 | 1 (13) |
Asthenia | 0 | 0 | 1 (13) |
Blood potassium decreased | 0 | 0 | 1 (13) |
Gastritis | 0 | 0 | 1 (13) |
Hypertension | 0 | 0 | 1 (13) |
Insomnia | 1 (8) | 0 | 1 (13) |
Nausea | 2 (17) | 0 | 1 (13) |
Right ventricular failure | 0 | 0 | 1 (13) |
Vomiting | 2 (17) | 0 | 1 (13) |
Worsening PAH | 0 | 0 | 1 (13) |
Chest discomfort | 2 (17) | 0 | 0 |
Dyspnoea | 2 (17) | 0 | 0 |
Pain in extremity | 2 (17) | 0 | 0 |
CHD, congenital heart disease; PAH, pulmonary arterial hypertension.