SAEs, deaths and discontinuation of the study drug
| QVA149 (110/50 µg) (N=476) | TIO (18 µg)+ FOR (12 µg) (N=458) | RR (95% CI)* | |
|---|---|---|---|
| Patients with any AE(s) | 208 (43.7) | 195 (42.6) | 1.03 (0.89 to 1.19) |
| AE(s) with suspected drug relationship | 32 (6.7) | 24 (5.2) | 1.28 (0.77 to 2.12) |
| AE(s) requiring concomitant medication/non-drug treatment | 96 (20.2) | 99 (21.6) | 0.93 (0.73 to 1.20) |
| AE(s) leading to dose adjustment or study drug interruption | 12 (2.5) | 9 (2.0) | 1.28 (0.55 to 2.92) |
| Patients with SAE(s) | 30 (6.3) | 24 (5.2) | 1.20 (0.72 to 2.01) |
| SAE(s) with suspected drug relation | 3 (0.6) | 1 (0.2) | 2.89 (0.33 to 15.14) |
| Discontinuations | |||
| Due to AEs | 20 (4.2) | 14 (3.1) | 1.38 (0.70 to 2.63) |
| Due to SAEs | 8 (1.7) | 6 (1.3) | 1.28 (0.46 to 3.47) |
| Deaths | 3 (0.6) | 3 (0.7) | 0.96 (0.22 to 4.21) |
Data are presented as n (%) unless otherwise stated. Safety set included all patients who received at least one dose of the study drug.
*Risk ratio is calculated as: % of QVA149/% of TIO+FOR.
AE, adverse event; FOR, formoterol; RR, risk ratio; SAE, serious adverse event; TIO, tiotropium.