Treatment-emergent adverse events in the subgroup of patients with PAH-CHD in Pulmonary Arterial hyperTENsion sGC-stimulator Trial-1
| 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.