Table 2.
AEs and SAEs (≥1% of patients in either treatment group), and death (safety set)
| Preferred term | Glycopyrrolate, N=222, n (%) | Placebo, N=216, n (%) |
|---|---|---|
| Patients with at least one AE | 95 (42.8) | 89 (41.2) |
| COPDa | 23 (10.4) | 29 (13.4) |
| Headache | 8 (3.6) | 6 (2.8) |
| Upper respiratory tract infection | 8 (3.6) | 6 (2.8) |
| Cough | 7 (3.2) | 5 (2.3) |
| Nasal congestion | 4 (1.8) | 4 (1.9) |
| Oropharyngeal pain | 4 (1.8) | 4 (1.9) |
| Pneumonia | 4 (1.8) | 0 |
| Bronchitis | 3 (1.4) | 2 (0.9) |
| Lower respiratory tract infection | 3 (1.4) | 0 |
| Nasopharyngitis | 3 (1.4) | 7 (3.2) |
| Sinusitis | 3 (1.4) | 2 (0.9) |
| Urinary tract infection | 3 (1.4) | 3 (1.4) |
| Vertigo | 3 (1.4) | 0 |
| Upper respiratory tract infection bacterial | 2 (0.9) | 5 (2.3) |
| Upper respiratory tract infection viral | 2 (0.9) | 3 (1.4) |
| Hyperkalemia | 1 (0.5) | 3 (1.4) |
| Abdominal pain | 0 | 3 (1.4) |
| Acute respiratory failure | 0 | 3 (1.4) |
| Patients with at least one SAE | 11 (5.0) | 12 (5.6) |
| COPDa | 2 (0.9) | 3 (1.4) |
| Death | 0 | 1 (0.5) |
Note:
a
Worsening of COPD which includes COPD exacerbation.
Abbreviations: AE, adverse event; COPD, chronic obstructive pulmonary disease; SAE, serious adverse event.