Overall PATENT-1 | Overall PAH-CTD | PAH-SSc | PAH-other defined CTD | |||||
---|---|---|---|---|---|---|---|---|
Riociguat (all doses) (n=317) | Placebo (n=126) | Riociguat (all doses) (n=86) | Placebo (n=25) | Riociguat (all doses) (n=50) | Placebo (n=16) | Riociguat (all doses) (n=33) | Placebo (n=6) | |
Any AE | 285 (90) | 108 (86) | 82 (95) | 24 (96) | 49 (98) | 15 (94) | 30 (91) | 6 (100) |
AEs experienced by ≥20% patients in any CTD group | ||||||||
Headache | 89 (28) | 25 (20) | 26 (30) | 9 (36) | 16 (32) | 8 (50) | 7 (21) | 1 (17) |
Nausea | 50 (16) | 16 (13) | 21 (24) | 3 (12) | 12 (24) | 3 (19) | 8 (24) | 0 |
Peripheral oedema | 58 (18) | 14 (11) | 16 (19) | 5 (20) | 11 (22) | 2 (13) | 5 (15) | 2 (33) |
Dizziness | 55 (17) | 15 (12) | 15 (17) | 3 (12) | 12 (24) | 1 (6) | 3 (9) | 1 (17) |
Diarrhoea | 41 (13) | 13 (10) | 13 (15) | 6 (24) | 9 (18) | 4 (25) | 3 (9) | 1 (17) |
Anaemia | 22 (7) | 3 (2) | 12 (14) | 3 (12) | 10 (20) | 2 (13) | 2 (6) | 1 (17) |
Pyrexia | 14 (4) | 4 (3) | 10 (12) | 1 (4) | 5 (10) | 0 | 4 (12) | 1 (17) |
Discontinuation due to AE | 9 (3) | 9 (7) | 3 (3) | 4 (16) | 3 (6) | 4 (25) | 0 | 0 |
AEs of special interest | ||||||||
Hypotension | 27 (9) | 3 (2) | 9 (10) | 1 (4) | 8 (16) | 0 | 1 (3) | 1 (17) |
Syncope | 3 (1) | 5 (4) | 1 (1) | 0 | 1 (2) | 0 | 0 | 0 |
Any SAE | 40 (13) | 23 (18) | 14 (16) | 7 (28) | 10 (20) | 5 (31) | 4 (12) | 2 (33) |
SAEs experienced by ≥5% patients in any CTD group | ||||||||
Right ventricular failure | 5 (2) | 1 (1) | 2 (2) | 1 (4) | 1 (2) | 1 (6) | 1 (3) | 0 |
Dyspnoea | 0 | 1 (1) | 0 | 1 (4) | 0 | 1 (6) | 0 | 0 |
Worsening PAH | 2 (1) | 2 (2) | 0 | 2 (8) | 0 | 2 (13) | 0 | 0 |
Discontinuation due to SAE | 5 (2) | 7 (6) | 1 (1) | 3 (12) | 1 (2) | 3 (19) | 0 | 0 |
Deaths | 3 (1) | 3 (2) | 0 | 1 (4) | 0 | 1 (6) | 0 | 0 |
AE, adverse event; CTD, connective tissue disease; PAH, pulmonary arterial hypertension; SAE, serious adverse event; SSc, systemic sclerosis.