Adverse event | Riociguat up to 2.5 mg t.i.d. (n=61) |
Most frequently reported adverse events# | |
Any | 58 (95) |
Dyspepsia | 14 (23) |
Headache | 12 (20) |
Diarrhoea | 11 (18) |
Dizziness | 10 (16) |
Hypotension | 10 (16) |
Nasopharyngitis | 9 (15) |
Vomiting | 9 (15) |
Peripheral oedema | 8 (13) |
Right ventricular failure | 7 (11) |
Adverse events of special interest | |
Hypotension | 10 (16) |
Symptomatic hypotension | 7 (11) |
Haemoptysis | 1 (2) |
Syncope | 0 (0) |
Study drug-related adverse events# | |
Any | 32 (52) |
Headache | 10 (16) |
Dyspepsia | 9 (15) |
Hypotension | 7 (11) |
Dizziness | 7 (11) |
Adverse events resulting in discontinuation of study drug | |
Any | 4 (7) |
Right ventricular failure | 2 (3) |
Dyspnoea | 2 (3) |
Hypotension | 2 (3) |
Renal failure | 1 (2) |
Asthenia | 1 (2) |
Serious adverse events | |
Any | 10 (16) |
Right ventricular failure¶,+,§ | 3 (5) |
Abdominal pain lower | 1 (2) |
Dyspepsia | 1 (2) |
Asthenia | 1 (2) |
Cholecystitis¶ | 1 (2) |
Pneumonia | 1 (2) |
Subdural haematoma | 1 (2) |
Depression | 1 (2) |
Renal failure¶ | 1 (2) |
Interventional procedure+ | 1 (2) |
Hypotension§ | 1 (2) |
Study drug-related serious adverse events | |
Any | 2 (3) |
Right ventricular failure | 1 (2) |
Asthenia | 1 (2) |
Data are presented as n (%). #: in >10% of patients; ¶: patient experienced three serious adverse events (right ventricular failure, cholecystitis and renal failure); +: patient experienced two serious adverse events (right ventricular failure and interventional procedure); §: patient experienced two serious adverse events (right ventricular failure and hypotension).