Adverse events (AE) in the PATENT-2 study
Former riociguat 2.5 mg maximum | Former riociguat 1.5 mg maximum | Former placebo | Total | |
Patients | 231 | 56 | 109 | 396 |
Any AE | 222 (96) | 55 (98) | 107 (98) | 384 (97) |
Individual AEs in >10% of patients | ||||
Nasopharyngitis | 55 (24) | 13 (23) | 27 (25) | 95 (24) |
Dizziness | 53 (23) | 12 (21) | 28 (26) | 93 (23) |
Peripheral oedema | 50 (22) | 14 (25) | 25 (23) | 89 (22) |
Cough | 52 (23) | 6 (11) | 20 (18) | 78 (20) |
Diarrhoea | 32 (14) | 11 (20) | 27 (25) | 70 (18) |
Headache | 33 (14) | 8 (14) | 27 (25) | 68 (17) |
Nausea | 41 (18) | 6 (11) | 19 (17) | 66 (17) |
Vomiting | 30 (13) | 8 (14) | 19 (17) | 57 (14) |
Upper respiratory tract infection | 29 (13) | 8 (14) | 17 (16) | 54 (14) |
Dyspnoea | 28 (12) | 11 (20) | 12 (11) | 51 (13) |
Dyspepsia | 29 (13) | 8 (14) | 10 (9) | 47 (12) |
Chest pain | 26 (11) | 6 (11) | 14 (13) | 46 (12) |
Epistaxis | 22 (10) | 10 (18) | 12 (11) | 44 (11) |
Drug-related AE | 123 (53) | 26 (46) | 66 (61) | 215 (54) |
Discontinued due to AE | 25 (11) | 4 (7) | 7 (6) | 36 (9) |
SAEs | 114 (49) | 30 (54) | 60 (55) | 204 (52) |
Discontinued due to SAE | 18 (8) | 4 (7) | 7 (6) | 29 (7) |
AEs of special interest in >5% of patients | ||||
Hypotension | 24 (10) | 6 (11) | 7 (6) | 37 (9) |
Syncope | 15 (6) | 3 (5) | 10 (9) | 28 (7) |
Other AEs of interest | ||||
Haemoptysis/pulmonary haemorrhage | 16 (7) | 2 (4) | 7 (6) | 25 (6) |
Data are presented as n or n (%). The mean treatment duration was 95 weeks. SAE: serious AE.