Table 4 Adverse events reported by ≥2% of patients in any treatment group in ACCLAIM/COPD I or ACCLAIM/COPD II
From: Efficacy and safety of once-daily aclidinium in chronic obstructive pulmonary disease
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 (%) | |
Nasopharyngitis | 102 (16.3) | 31 (14.4) | 76 (12.7) | 23 (11.3) |
Headache | 71 (11.3) | 27 (12.5) | 85 (14.2) | 26 (12.7) |
Upper respiratory tract infection | 8 (1.3) | 3 (1.4) | 65 (10.8) | 20 (9.8) |
Back pain | 30 (4.8) | 10 (4.6) | 40 (6.7) | 15 (7.4) |
Diarrhoea | 17 (2.7) | 1 (0.5) | 42 (7.0) | 8 (3.9) |
Pharyngolaryngeal pain | 21 (3.3) | 3 (1.4) | 25 (4.2) | 11 (5.4) |
Urinary tract infection | 5 (0.8) | 2 (0.9) | 29 (4.8) | 10 (4.9) |
Cough | 29 (4.6) | 8 (3.7) | 29 (4.8) | 8 (3.9) |
Hypertension | 9 (1.4) | 9 (4.2) | 27 (4.5) | 6 (2.9) |
Sinusitis | 5 (0.8) | 1 (0.5) | 27 (4.5) | 9 (4.4) |
Dyspnoea | 12 (1.9) | 5 (2.3) | 17 (2.8) | 9 (4.4) |
Arthralgia | 17 (2.7) | 1 (0.5) | 24 (4.0) | 5 (2.5) |
Influenza | 21 (3.3) | 4 (1.9) | 22 (3.7) | 8 (3.9) |
Pain in extremity | 5 (0.8) | 3 (1.4) | 23 (3.8) | 4 (2.0) |
Dizziness | 15 (2.4) | 6 (2.8) | 19 (3.2) | 7 (3.4) |
Abdominal pain | 6 (1.0) | 3 (1.4) | 20 (3.3) | 0 (0.0) |
Muscle spasms | 4 (0.6) | 0 (0.0) | 19 (3.2) | 5 (2.5) |
Musculoskeletal pain | 7 (1.1) | 1 (0.5) | 19 (3.2) | 3 (1.5) |
Pneumonia | 12 (1.9) | 7 (3.2) | 10 (1.7) | 4 (2.0) |
Rhinitis | 12 (1.9) | 7 (3.2) | 14 (2.3) | 4 (2.0) |
Myalgia | 3 (0.5) | 3 (1.4) | 18 (3.0) | 3 (1.5) |
Oedema peripheral | 7 (1.1) | 2 (0.9) | 18 (3.0) | 2 (1.0) |
Chest pain | 5 (0.8) | 1 (0.5) | 10 (1.7) | 6 (2.9) |
Insomnia | 7 (1.1) | 1 (0.5) | 8 (1.3) | 6 (2.9) |
Nausea | 8 (1.3) | 3 (1.4) | 16 (2.7) | 6 (2.9) |
Viral infection | 9 (1.4) | 6 (2.8) | 5 (0.8) | 3 (1.5) |
Bronchitis | 4 (0.6) | 1 (0.5) | 10 (1.7) | 5 (2.5) |
Depression | 3 (0.5) | 3 (1.4) | 15 (2.5) | 4 (2.0) |
Blood glucose increased | 3 (0.5) | 4 (1.9) | 3 (0.5) | 5 (2.5) |
Epistaxis | 5 (0.8) | 0 (0.0) | 8 (1.3) | 5 (2.5) |
Neck pain | 7 (1.1) | 0 (0.0) | 6 (1.0) | 5 (2.5) |
Procedural pain | 1 (0.2) | 1 (0.5) | 5 (0.8) | 5 (2.5) |
Vomiting | 7 (1.1) | 0 (0.0) | 15 (2.5) | 5 (2.5) |
Contusion | 11 (1.8) | 3 (1.4) | 14 (2.3) | 1 (0.5) |
Rash | 2 (0.3) | 0 (0.0) | 14 (2.3) | 3 (1.5) |
Toothache | 12 (1.9) | 5 (2.3) | 12 (2.0) | 2 (1.0) |
Constipation | 4 (0.6) | 0 (0.0) | 13 (2.2) | 4 (2.0) |
Gamma-glutamyl transferase increased | 13 (2.1) | 2 (0.9) | 2 (0.3) | 3 (1.5) |
Angina pectoris | 4 (0.6) | 3 (1.4) | 3 (0.5) | 4 (2.0) |
Fatigue | 4 (0.6) | 1 (0.5) | 10 (1.7) | 4 (2.0) |
Lower respiratory tract infection | 5 (0.8) | 0 (0.0) | 5 (0.8) | 4 (2.0) |
Musculoskeletal chest pain | 7 (1.1) | 1 (0.5) | 12 (2.0) | 4 (2.0) |
Pain | 0 (0.0) | 0 (0.0) | 6 (1.0) | 4 (2.0) |
Pyrexia | 8 (1.3) | 3 (1.4) | 12 (2.0) | 1 (0.5) |
Rhinorrhoea | 2 (0.3) | 1 (0.5) | 9 (1.5) | 4 (2.0) |
Syncope | 1 (0.2) | 0 (0.0) | 2 (0.3) | 4 (2.0) |