TABLE 2

Adverse events (AE) in the PATENT-2 study

Former riociguat 2.5mg maximumFormer riociguat 1.5 mg maximumFormer placeboTotal
Patients23156109396
Any AE222 (96)55 (98)107 (98)384 (97)
Individual AEs in >10%  of patients
 Nasopharyngitis55 (24)13 (23)27 (25)95 (24)
 Dizziness53 (23)12 (21)28 (26)93 (23)
 Peripheral oedema50 (22)14 (25)25 (23)89 (22)
 Cough52 (23)6 (11)20 (18)78 (20)
 Diarrhoea32 (14)11 (20)27 (25)70 (18)
 Headache33 (14)8 (14)27 (25)68 (17)
 Nausea41 (18)6 (11)19 (17)66 (17)
 Vomiting30 (13)8 (14)19 (17)57 (14)
 Upper respiratory   tract infection29 (13)8 (14)17 (16)54 (14)
 Dyspnoea28 (12)11 (20)12 (11)51 (13)
 Dyspepsia29 (13)8 (14)10 (9)47 (12)
 Chest pain26 (11)6 (11)14 (13)46 (12)
 Epistaxis22 (10)10 (18)12 (11)44 (11)
Drug-related AE123 (53)26 (46)66 (61)215 (54)
Discontinued due to AE25 (11)4 (7)7 (6)36 (9)
SAEs114 (49)30 (54)60 (55)204 (52)
Discontinued due to SAE18 (8)4 (7)7 (6)29 (7)
AEs of special interest  in >5% of patients
 Hypotension24 (10)6 (11)7 (6)37 (9)
 Syncope15 (6)3 (5)10 (9)28 (7)
Other AEs of interest
 Haemoptysis/pulmonary   haemorrhage16 (7)2 (4)7 (6)25 (6)
  • Data are presented as n or n (%). The mean treatment duration was 95 weeks. SAE: serious AE.