Table 2

Most frequent AEs (excluding COPD exacerbations) in safety set population

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
 Nasopharyngitis42 (8.8)53 (11.6)0.76 (0.52 to 1.12)
 Cough26 (5.5)20 (4.4)1.25 (0.71 to 2.18)
 Dyspnoea9 (1.9)17 (3.7)0.51 (0.24 to 1.14)
 Headache7 (1.5)9 (2.0)0.75 (0.29 to 1.96)
 Hypertension7 (1.5)5 (1.1)1.35 (0.44 to 3.91)
 Back pain6 (1.3)7 (1.5)0.83 (0.29 to 2.37)
 Dry mouth6 (1.3)6 (1.3)0.96 (0.33 to 2.83)
 Rhinitis6 (1.3)5 (1.1)1.16 (0.37 to 3.51)
 Bronchitis5 (1.1)3 (0.7)1.60 (0.40 to 5.74)
 Hypercholesterolaemia5 (1.1)1 (0.2)4.81 (0.58 to 21.36)
 Influenza4 (0.8)5 (1.1)0.77 (0.23 to 2.72)
 Diarrhoea4 (0.8)2 (0.4)1.92 (0.37 to 8.09)
 Myocardial infarction4 (0.8)1 (0.2)3.85 (0.46 to 18.24)
 Dysphonia3 (0.6)4 (0.9)0.72 (0.19 to 3.01)
 Cystitis2 (0.4)6 (1.3)0.32 (0.09 to 1.58)
 Chest discomfort2 (0.4)4 (0.9)0.48 (0.12 to 2.50)
 Vertigo2 (0.4)4 (0.9)0.48 (0.12 to 2.50)
 Muscle spasms1 (0.2)7 (1.5)0.14 (0.03 to 1.11)
 Pneumonia1 (0.2)8 (1.7)0.12 (0.03 to 0.96)
 Upper abdominal pain1 (0.2)4 (0.9)0.24 (0.05 to 2.03)
 Upper respiratory tract infection0 (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.