Table 4 Frequency of adverse events occurring in ≥ 3% of patients in either group, serious adverse events occurring in two or more patients in either group, deaths, discontinuations due to adverse events and electrocardiographic abnormalities
From: Efficacy and safety of once-daily NVA237 in patients with moderate-to-severe COPD: the GLOW1 trial
|  | NVA237 50 μg (n = 550) | Placebo (n = 267) |
|---|---|---|
Patients with adverse events, n (%) | 317 (57.5) | 174 (65.2) |
   COPD worsening | 111 (20.2) | 73 (27.3) |
   Nasopharyngitis | 28 (5.1) | 21 (7.9) |
   Cough | 26 (4.7) | 13 (4.9) |
   Upper respiratory tract infection | 23 (4.2) | 20 (7.5) |
   Dyspnoea | 18 (3.3) | 10 (3.7) |
   Pyrexia | 17 (3.1) | 13 (4.9) |
   Upper respiratory tract infection, bacterial | 17 (3.1) | 12 (4.5) |
   Headache | 14 (2.5) | 10 (3.7) |
Patients with serious adverse events*, n (%) | 46 (8.4) | 24 (9.0) |
   COPD worsening | 9 (1.6) | 11 (4.1) |
   Pneumonia | 4 (0.7) | 2 (0.7) |
   Upper respiratory tract infection, bacterial | 3 (0.5) | 2 (0.7) |
   Atrial fibrillation | 3 (0.5) | 0 |
   Dyspnoea | 2 (0.4) | 0 |
   Respiratory failure | 2 (0.4) | 0 |
   Cardiac failure congestive | 2 (0.4) | 0 |
   Myocardial infarction | 2 (0.4) | 1 (0.4) |
   Lung neoplasm | 2 (0.4) | 0 |
   Syncope | 2 (0.4) | 0 |
   Upper respiratory tract infection | 0 | 2 (0.7) |
   Myocardial ischaemia | 0 | 2 (0.7) |
Deaths**, n (%) | 3 (0.5) | 3 (1.1) |
Discontinuations due to adverse events, n (%) | 32 (5.8) | 19 (7.1) |
Electrocardiographic abnormalities, n (%) | Â | Â |
   Notable QTcF†| 22 (4.0) | 3 (1.1) |
   QTcF > 500 ms | 0 | 0 |
   Increase from baseline of 30-60 ms | 59 (10.7) | 21 (7.9) |
   Increase from baseline of > 60 ms | 6 (1.1) | 1 (0.4) |