Table 3.
Summary of AEs during treatment with riociguat
| AE, n (%) | Full analysis set (n = 300) |
Switched patients (n = 84)a |
Treatment-naïve patients (n = 216) |
|---|---|---|---|
| Any AE | 273 (91) | 76 (90) | 197 (91) |
| Drug-related AEs | 178 (59) | 53 (63) | 125 (58) |
| Serious AEs | 89 (30) | 22 (26) | 67 (31) |
| Drug-related serious AEs | 19 (6) | 4 (5) | 15 (7) |
| AEs leading to discontinuation of study medication | 14 (5) | 5 (6) | 9 (4) |
| Deaths | 5 (2) | 0 | 5 (2) |
AE adverse event, PDE5 phosphodiesterase type 5, ERA endothelin receptor antagonist
aPatients who previously received an ERA, prostacyclin, and/or PDE5 inhibitor, and who stopped this treatment before starting riociguat