QVA149 (110/50 µg) (N=476) | TIO (18 µg)+ FOR (12 µg) (N=458) | RR (95% CI)* | |
---|---|---|---|
Patients with any AE(s) (total) | 208 (43.7) | 195 (42.6) | 1.03 (0.89 to 1.19) |
Preferred term | |||
Nasopharyngitis | 42 (8.8) | 53 (11.6) | 0.76 (0.52 to 1.12) |
Cough | 26 (5.5) | 20 (4.4) | 1.25 (0.71 to 2.18) |
Dyspnoea | 9 (1.9) | 17 (3.7) | 0.51 (0.24 to 1.14) |
Headache | 7 (1.5) | 9 (2.0) | 0.75 (0.29 to 1.96) |
Hypertension | 7 (1.5) | 5 (1.1) | 1.35 (0.44 to 3.91) |
Back pain | 6 (1.3) | 7 (1.5) | 0.83 (0.29 to 2.37) |
Dry mouth | 6 (1.3) | 6 (1.3) | 0.96 (0.33 to 2.83) |
Rhinitis | 6 (1.3) | 5 (1.1) | 1.16 (0.37 to 3.51) |
Bronchitis | 5 (1.1) | 3 (0.7) | 1.60 (0.40 to 5.74) |
Hypercholesterolaemia | 5 (1.1) | 1 (0.2) | 4.81 (0.58 to 21.36) |
Influenza | 4 (0.8) | 5 (1.1) | 0.77 (0.23 to 2.72) |
Diarrhoea | 4 (0.8) | 2 (0.4) | 1.92 (0.37 to 8.09) |
Myocardial infarction | 4 (0.8) | 1 (0.2) | 3.85 (0.46 to 18.24) |
Dysphonia | 3 (0.6) | 4 (0.9) | 0.72 (0.19 to 3.01) |
Cystitis | 2 (0.4) | 6 (1.3) | 0.32 (0.09 to 1.58) |
Chest discomfort | 2 (0.4) | 4 (0.9) | 0.48 (0.12 to 2.50) |
Vertigo | 2 (0.4) | 4 (0.9) | 0.48 (0.12 to 2.50) |
Muscle spasms | 1 (0.2) | 7 (1.5) | 0.14 (0.03 to 1.11) |
Pneumonia† | 1 (0.2) | 8 (1.7) | 0.12 (0.03 to 0.96) |
Upper abdominal pain | 1 (0.2) | 4 (0.9) | 0.24 (0.05 to 2.03) |
Upper respiratory tract infection | 0 (0) | 4 (0.9) | NE (0.01 to 1.98) |
Data are presented as n (%) unless otherwise stated. Listed adverse events (using Medical Dictionary for Regulatory Activities high-level group terms) occurred in at least four patients in any treatment group. Safety set population included all patients, receiving at least one dose of study drug.
*Risk ratio is calculated as % of QVA149/ % of TIO+FOR.
†Confirmed by chest X-ray examination.
AE, adverse event; FOR, formoterol; NE, not estimable; RR, risk ratio; TIO, tiotropium.