Table 4 Most frequent AEs (at least three patients in either treatment group) and discontinuations due to AEs (safety set), n (%)
Preferred term | Glycopyrronium 50 μg o.d. (N = 327) n (%) | Tiotropium 18 μg o.d. (N = 330) n (%) |
|---|---|---|
Any AE | 132 (40.4) | 134 (40.6) |
COPD worsening | 50 (15.3) | 58 (17.6) |
Nasopharyngitis | 14 (4.3) | 8 (2.4) |
Headache | 12 (3.7) | 7 (2.1) |
Bacterial upper respiratory tract infection | 10 (3.1) | 11 (3.3) |
Upper respiratory tract infection | 9 (2.8) | 5 (1.5) |
Cough | 5 (1.5) | 5 (1.5) |
Viral upper respiratory tract infection | 5 (1.5) | 6 (1.8) |
Urinary tract infection | 4 (1.2) | 1 (0.3) |
Lower respiratory tract infection | 3 (0.9) | 3 (0.9) |
Influenza | 2 (0.6) | 4 (1.2) |
Non-cardiac chest pain | 2 (0.6) | 3 (0.9) |
Pneumonia | 2 (0.6) | 3 (0.9) |
Arthralgia | 1 (0.3) | 5 (1.5) |
Dry mouth | 1 ( 0.3) | 5 (1.5) |
Odema peripheral | 1 ( 0.3) | 5 (1.5) |
Blood glucose increased | 0 | 3 (0.9) |
Gastritis | 0 | 3 (0.9) |
Renal failure acute | 0 | 3 (0.9) |
Sinusitis | 0 | 3 (0.9) |
Discontinuation due to AE(s) | 7 (2.1) | 5 (1.5) |