Table 5 Patients with ≥2 possible anticholinergic adverse events in any group in ACCLAIM/COPD I or ACCLAIM/COPD II (by system organ class and preferred term)
From: Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease
System organ class | Adverse event preferred term | ACCLAIM/COPD I | ACCLAIM/COPD II | ||
|---|---|---|---|---|---|
Aclidinium 200 μg (n = 627) n (%) | Placebo (n = 216) n (%) | Aclidinium 200 μg (n = 600) n (%) | Placebo (n = 204) n (%) | ||
Atrial fibrillation | 3 (0.5) | 2 (0.9) | 3 (0.5) | 0 (0.0) | |
Atrial flutter | 0 (0.0) | 0 (0.0) | 2 (0.3) | 1 (0.5) | |
Cardiac disorders | Sinus tachycardia | 2 (0.3) | 1 (0.5) | 1 (0.2) | 0 (0.0) |
Tachycardia | 3 (0.5) | 0 (0.0) | 3 (0.5) | 1 (0.5) | |
Ventricular extrasystoles | 1 (0.2) | 1 (0.5) | 3 (0.5) | 0 (0.0) | |
Dry eye | 1 (0.2) | 1 (0.5) | 5 (0.8) | 0 (0.0) | |
Eye irritation | 0 (0.0) | 0 (0.0) | 3 (0.5) | 1 (0.5) | |
Eye disorders | Eye pain | 3 (0.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Vision blurred | 0 (0.0) | 0 (0.0) | 3 (0.5) | 1 (0.5) | |
Visual acuity reduced | 0 (0.0) | 0 (0.0) | 2 (0.3) | 1 (0.5) | |
Gastrointestinal disorders | Constipation | 4 (0.6) | 0 (0.0) | 13 (2.2) | 4 (2.0) |
Dry mouth | 6 (1.0) | 2 (0.9) | 2 (0.3) | 3 (1.5) | |
Infections and infestations | Urinary tract infection | 0 (0.0) | 0 (0.0) | 29 (4.8) | 10 (4.9) |