PATENT-1 | CHEST-1 | ||||
---|---|---|---|---|---|
Event, n (%) | Placebo (n=24) | Riociguat 2.5 mg-maximum group (n=43) | Riociguat 1.5 mg-maximum group (n=10) | Placebo (n=11) | Riociguat 2.5 mg-maximum group (n=21) |
Clinical worsening | |||||
All events | 1 (4) | 1 (2) | 0 | 1 (9) | 0 |
Death | 1 (4) | 1 (2) | 0 | 1 (9) | 0 |
AEs | |||||
Any | 18 (75) | 33 (77) | 9 (90) | 11 (100) | 21 (100) |
Peripheral oedema | 3 (13) | 5 (12) | 0 | 3 (27) | 2 (10) |
Headache | 1 (4) | 6 (14) | 3 (30) | 0 | 5 (24) |
Hypotension | 0 | 6 (14) | 1 (10) | 0 | 0 |
Dizziness | 1 (4) | 4 (9) | 1 (10) | 0 | 7 (33) |
Upper respiratory tract infection | 3 (13) | 1 (2) | 0 | 2 (18) | 2 (10) |
Chest discomfort | 4 (17) | 1 (2) | 0 | 0 | 2 (10) |
Cough | 2 (8) | 2 (5) | 1 (10) | 3 (27) | 1 (5) |
Nausea | 2 (8) | 1 (2) | 1 (10) | 1 (9) | 1 (5) |
Gastro-oesophageal reflux disease | 2 (8) | 2 (5) | 0 | 0 | 2 (10) |
Abdominal discomfort | 0 | 2 (5) | 0 | 0 | 5 (24) |
Dyspepsia | 0 | 2 (5) | 2 (20) | 0 | 2 (10) |
Erythema | 0 | 0 | 2 (20) | 2 (18) | 0 |
Palpitations | 0 | 2 (5) | 1 (10) | 0 | 2 (10) |
Nasopharyngitis | 3 (13) | 1 (2) | 1 (10) | 0 | 0 |
Presyncope | 0 | 0 | 1 (10) | 0 | 0 |
Constipation | 1 (4) | 0 | 1 (10) | 0 | 0 |
Dysphagia | 0 | 1 (2) | 1 (10) | 0 | 0 |
Prolonged activated partial thromboplastin time | 3 (13) | 3 (7) | 0 | 2 (18) | 8 (38) |
Increased blood glucose | 0 | 0 | 1 (10) | 0 | 0 |
Decreased potassium | 1 (4) | 2 (5) | 1 (10) | 1 (9) | 0 |
Increased INR | 3 (13) | 4 (9) | 0 | 1 (9) | 7 (33) |
Decreased WBC count | 0 | 0 | 0 | 1 (9) | 2 (10) |
Hypokalaemia | 0 | 1 (2) | 3 (30) | 0 | 0 |
Dyspnoea | 1 (4) | 1 (2) | 1 (10) | 0 | 0 |
Productive cough | 1 (4) | 0 | 1 (10) | 0 | 1 (5) |
The AEs listed here are those that occurred in ≥10% of the patients in any group during the treatment period.
AE, adverse event; INR, international normalised ratio; WBC, white blood cell.