Patients | 174¶ | 171 | 174 | 519¶ |
Any TE-AE | 127 (73.0) | 94 (55.0) | 116 (66.7) | 337 (64.9) |
Any drug-related TE-AE | 28 (16.1) | 19 (11.1) | 24 (13.8) | 71 (13.7) |
TE-AE with outcome death | 3 (1.7) | 4 (2.3) | 2 (1.1) | 9 (1.7) |
Discontinuation due to TE-AE | 10 (5.7) | 6 (3.5) | 10 (5.7) | 26 (5.0) |
Any serious TE-AE | 45 (25.9) | 28 (16.4) | 41 (23.6) | 114 (22.0) |
Any drug-related serious TE-AE | 0 | 1 (0.6) | 0 | 1 (0.2) |
TE-AE reported in at least 5% of patients in any group | | | | |
Respiratory, thoracic and mediastinal disorders | 70 (40.2) | 42 (24.6) | 68 (39.1) | 180 (34.7) |
Bronchiectasis | 24 (13.8) | 17 (9.9) | 21 (12.1) | 62 (11.9) |
Haemoptysis | 17 (9.8) | 12 (7.0) | 22 (12.6) | 51 (9.8) |
Cough | 7 (4.0) | 5 (2.9) | 11 (6.3) | 23 (4.4) |
Bronchospasm | 7 (4.0) | 3 (1.8) | 9 (5.2) | 19 (3.7) |
Dyspnoea | 10 (5.7) | 4 (2.3) | 3 (1.7) | 17 (3.3) |
Infections and infestations | 49 (28.2) | 45 (26.3) | 43 (24.7) | 137 (26.4) |
Nasopharyngitis | 16 (9.2) | 10 (5.8) | 14 (8.0) | 40 (7.7) |
Upper respiratory tract infections | 8 (4.6) | 10 (5.8) | 5 (2.9) | 23 (4.4) |
Gastrointestinal disorders | 29 (16.7) | 22 (12.9) | 26 (14.9) | 77 (14.8) |
Nervous system disorders | 25 (14.4) | 26 (15.2) | 12 (6.9) | 63 (12.1) |
Headache | 10 (5.7) | 10 (5.8) | 5 (2.9) | 25 (4.8) |
Dysgeusia | 8 (4.6) | 9 (5.3) | 2 (1.1) | 19 (3.7) |
General disorders and administration site conditions | 14 (8.0) | 14 (8.2) | 13 (7.5) | 41 (7.9) |
Musculoskeletal and connective tissue disorders | 18 (10.3) | 12 (7.0) | 10 (5.7) | 40 (7.7) |
Skin and subcutaneous tissue disorders | 12 (6.9) | 8 (4.7) | 11 (6.3) | 31 (6.0) |
Investigations | 13 (7.5) | 6 (3.5) | 10 (5.7) | 29 (5.6) |
Metabolism and nutrition disorders | 11 (6.3) | 5 (2.9) | 8 (4.6) | 24 (4.6) |
Vascular disorders | 9 (5.2) | 5 (2.9) | 6 (3.4) | 20 (3.9) |