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
| 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 (%) | ||
| 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) |
* Includes five patients in the NVA237 group that had a serious adverse event that occurred during the 30-day follow-up period. **Includes one patient with a co-existing history of depression in NVA237 group, who died within 30 days after discontinuing from the study due to suicide/depression. † > 450 ms for men and > 470 ms for women
QTcF: QTc interval with Fridericia's correction