Table 4 AEs occurring in ≥10% of patients and AEs of special interest occurring during treatment with riociguat
Full analysis set (n = 300) | Incidence per 100 patient-years | |
|---|---|---|
AE, n (%) | ||
Dyspepsia | 60 (20) | 27.5 |
Dizziness | 56 (19) | 26.0 |
Headache | 54 (18) | 29.4 |
Peripheral edema | 54 (18) | 23.0 |
Diarrhea | 45 (15) | 20.0 |
Nausea | 43 (14) | 18.8 |
Cough | 38 (13) | 16.6 |
Vomiting | 34 (11) | 16.6 |
Hypotension | 29 (10) | 12.4 |
Constipation | 31 (10) | 13.6 |
Gastroesophageal reflux disease | 31 (10) | 12.8 |
Nasopharyngitis | 31 (10) | 14.7 |
AE of special interest, n (%) | ||
Pre-syncope | 10 (3) | 4.1 |
Syncope | 17 (6) | 9.8 |