Table 2.
AEs in ≥2 % of patients (safety population)
| Number (%) patients | |||
|---|---|---|---|
| BF Spiromax 160/4.5 mcg | BF Turbuhaler 200/6 mcg | Total | |
| (n = 303) | (n = 299) | (N = 602) | |
| Patients with at least one AE | 117 (39) | 106 (35) | 223 (37) |
| Infections and infestations | 61 (20) | 69 (23) | 130 (22) |
| Nasopharyngitis | 31 (10) | 25 (8) | 56 (9) |
| Rhinitis | 6 (2) | 7 (2) | 13 (2) |
| Bronchitis | 3 (<1) | 7 (2) | 10 (2) |
| Respiratory, thoracic and mediastinal disorders | 33 (11) | 22 (7) | 55 (9) |
| Cough | 11 (4) | 8 (3) | 19 (3) |
| Oropharyngeal pain | 7 (2) | 5 (2) | 12 (2) |
| Dysphonia | 9 (3) | 1 (<1) | 10 (2) |
| Nervous system disorders | 21 (7) | 26 (9) | 47 (8) |
| Headache | 18 (6) | 24 (8) | 42 (7) |
| Gastrointestinal disorders | 18 (6) | 14 (5) | 32 (5) |
| General disorders and administration site conditions | 9 (3) | 4 (1) | 13 (2) |
AE adverse event, BF budesonide–formoterol