Table 5 AEs occurring in ≥ 2% of patients
BF Spiromax (N = 197) | BF Turbuhaler (N = 197) | |
|---|---|---|
Patients with at least 1 AE, n (%) | 113 (57.4) | 119 (60.4) |
Infections and infestations | ||
Lower respiratory tract infection | 17 (8.6) | 31 (15.7) |
Urinary tract infection | 5 (2.5) | 2 (1.0) |
Nervous system disorders | ||
Headache | 5 (2.5) | 2 (1.0) |
Respiratory, thoracic, and mediastinal disorders | ||
Asthma (worsening of asthma or asthma attack) | 8 (4.1) | 9 (4.6) |
Cough | 11 (5.6) | 12 (6.1) |
Dyspnea | 5 (2.5) | 5 (2.5) |
Wheezing | 4 (2.0) | 3 (1.5) |
Number of patients with at least 1 serious AE, n (%) | 4 (2.0) | 8 (4.1) |