Subjects n | 155 | 82 | 237 |
Any AE | 150 (97) | 78 (95) | 228 (96) |
Individual AEs in >10% of patients | | | |
Nasopharyngitis | 37 (24) | 18 (22) | 55 (23) |
Dizziness | 29 (19) | 16 (20) | 45 (19) |
Peripheral oedema | 24 (15) | 19 (23) | 43 (18) |
Diarrhoea | 21 (14) | 12 (15) | 33 (14) |
Cough | 20 (13) | 12 (15) | 32 (14) |
Dyspnoea | 18 (12) | 9 (11) | 27 (11) |
Upper respiratory tract infection | 18 (12) | 8 (10) | 26 (11) |
Drug-related AE | 70 (45) | 39 (48) | 109 (46) |
Discontinuation due to AE | 3 (2) | 5 (6) | 8 (3) |
Serious AEs | 63 (41) | 37 (45) | 100 (42) |
Discontinuation due to serious AE | 3 (2) | 4 (5) | 7 (3) |
AEs of special interest in >5% of patients | | | |
Syncope | 10 (6) | 7 (9) | 17 (7) |
Hypotension | 9 (6) | 6 (7) | 15 (6) |
Other AEs of interest | | | |
Haemoptysis/pulmonary haemorrhage | 5 (3) | 3 (4) | 8 (3) |