Adverse events occurring in more than 5% of patients in any group
| Adverse event, n (%) | Inoperable | Persistent/recurrent PH following PEA | ||
|---|---|---|---|---|
| Riociguat (n=121) | Placebo (n=68) | Riociguat (n=52) | Placebo (n=20) | |
| Any | 108 (89) | 61 (90) | 51 (98) | 15 (75) |
| Dizziness | 27 (22) | 8 (12) | 12 (23) | 3 (15) |
| Headache | 26 (21) | 8 (12) | 17 (33) | 4 (20) |
| Dyspepsia | 20 (17) | 6 (9) | 11 (21) | 1 (5) |
| Peripheral oedema | 17 (14) | 15 (22) | 10 (19) | 3 (15) |
| Nasopharyngitis | 14 (12) | 6 (9) | 12 (23) | 2 (10) |
| Hypotension | 13 (11) | 3 (4) | 3 (6) | 0 |
| Diarrhoea | 11 (9) | 3 (4) | 6 (12) | 1 (5) |
| Nausea | 9 (7) | 6 (9) | 10 (19) | 1 (5) |
| Upper respiratory tract infection | 9 (7) | 3 (4) | 1 (2) | 1 (5) |
| Vomiting | 8 (7) | 2 (3) | 9 (17) | 1 (5) |
| Increased INR | 8 (7) | 4 (6) | 2 (4) | 0 |
| Prolonged aPTT | 7 (6) | 2 (3) | 1 (2) | 0 |
| Cough | 6 (5) | 11 (16) | 3 (6) | 5 (25) |
| Dyspnoea | 6 (5) | 9 (13) | 2 (4) | 3 (15) |
| Urinary tract infection | 6 (5) | 0 | 1 (2) | 2 (10) |
| Abdominal discomfort | 6 (5) | 0 | 0 | 2 (10) |
| Back pain | 5 (4) | 5 (7) | 2 (4) | 0 |
| Chest pain | 5 (4) | 4 (6) | 2 (4) | 0 |
| Flushing | 4 (3) | 2 (3) | 3 (6) | 0 |
| Gastro-oesophageal reflux disease | 4 (3) | 0 | 3 (6) | 0 |
| Hypokalaemia | 3 (2) | 2 (3) | 4 (8) | 0 |
| Extremity pain | 3 (2) | 5 (7) | 0 | 0 |
| Hyperkalaemia | 3 (2) | 0 | 0 | 2 (10) |
| Palpitations | 2 (2) | 2 (3) | 4 (8) | 2 (10) |
| Insomnia | 2 (2) | 5 (7) | 2 (4) | 1 (5) |
| Muscle spasms | 1 (1) | 2 (3) | 3 (6) | 0 |
| Respiratory tract infection | 1 (1) | 0 | 3 (6) | 1 (5) |
| Hyperhidrosis | 1 (1) | 2 (3) | 0 | 2 (10) |
| Increased blood creatinine | 0 | 4 (6) | 3 (6) | 1 (5) |
| Oropharyngeal pain | 0 | 0 | 3 (6) | 0 |
aPTT, activated partial thromboplastin time; INR, international normalised ratio; PEA, pulmonary endarterectomy; PH, pulmonary hypertension.