Patients | 136¶ | 141 | 137¶ | 414¶ |
Any TE-AE | 112 (82.4) | 110 (78.0) | 114 (83.2) | 336 (81.2) |
Any drug-related TE-AE | 33 (24.3) | 35 (24.8) | 36 (26.3) | 104 (25.1) |
TE-AE with outcome death | 1 (0.7) | 2 (1.4) | 3 (2.2) | 6 (1.4) |
Discontinuation due to TE-AE | 17 (12.5) | 14 (9.9) | 19 (13.9) | 50 (12.1) |
Any serious TE-AE | 23 (16.9) | 28 (19.9) | 32 (23.4) | 83 (20.0) |
Any drug-related serious TE-AE | 2 (1.5) | 3 (2.1) | 1 (0.7) | 6 (1.4) |
TE-AEs reported in at least 5% of patients in any group | | | | |
Respiratory, thoracic and mediastinal disorders | 64 (47.1) | 62 (44.0) | 59 (43.1) | 185 (44.7) |
Bronchiectasis | 8 (5.9) | 16 (11.3) | 17 (12.4) | 41 (9.9) |
Dyspnoea | 16 (11.8) | 16 (11.3) | 9 (6.6) | 41 (9.9) |
Haemoptysis | 16 (11.8) | 15 (10.6) | 10 (7.3) | 41 (9.9) |
Cough | 13 (9.6) | 15 (10.6) | 9 (6.6) | 37 (8.9) |
Bronchospasm | 7 (5.1) | 7 (5.0) | 10 (7.3) | 24 (5.8) |
Sputum increased | 6 (4.4) | 8 (5.7) | 3 (2.2) | 17 (4.1) |
Oropharyngeal pain | 7 (5.1) | 3 (2.1) | 5 (3.6) | 15 (3.6) |
Infections and infestations | 50 (36.8) | 69 (48.9) | 63 (46.0) | 182 (44.0) |
Nasopharyngitis | 16 (11.8) | 15 (10.6) | 10 (7.3) | 41 (9.9) |
Upper respiratory tract infection | 9 (6.6) | 4 (2.8) | 10 (7.3) | 23 (5.6) |
Sinusitis | 10 (7.4) | 4 (2.8) | 8 (5.8) | 22 (5.3) |
Pneumonia | 5 (3.7) | 7 (5.0) | 7 (5.1) | 19 (4.6) |
Gastrointestinal disorders | 41 (30.1) | 34 (24.1) | 36 (26.3) | 111 (26.8) |
Nausea | 10 (7.4) | 5 (3.5) | 7 (5.1) | 22 (5.3) |
Diarrhoea | 9 (6.6) | 7 (5.0) | 5 (3.6) | 21 (5.1) |
Nervous system disorders | 33 (24.3) | 31 (22.0) | 18 (13.1) | 82 (19.8) |
Headache | 14 (10.3) | 11 (7.8) | 4 (2.9) | 29 (7.0) |
Dizziness | 7 (5.1) | 2 (1.4) | 1 (0.7) | 10 (2.4) |
General disorders and administration site conditions | 33 (24.3) | 26 (18.4) | 16 (11.7) | 75 (18.1) |
Fatigue | 12 (8.8) | 6 (4.3) | 3 (2.2) | 21 (5.1) |
Chest pain | 7 (5.1) | 5 (3.5) | 7 (5.1) | 19 (4.6) |
Musculoskeletal and connective tissue disorders | 28 (20.6) | 31 (22.0) | 16 (11.7) | 75 (18.1) |
Back pain | 9 (6.6) | 10 (7.1) | 6 (4.4) | 25 (6.0) |
Arthralgia | 4 (2.9) | 7 (5.0) | 1 (0.7) | 12 (2.9) |
Investigations | 26 (19.1) | 16 (11.3) | 11 (8.0) | 53 (12.8) |
Aspergillus test positive | 7 (5.1) | 6 (4.3) | 0 (0) | 13 (3.1) |