Clinical worsening events and AEs in Chinese patients in PATENT-1 and CHEST-1
| 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.