Patients | 516 | 518 | |
TDI score | | | |
Day 28# | | | Difference |
Patients with analysable data | 502 | 497 | |
Change from baseline | 1.36±0.116 | 1.31±0.116 | 0.05 (−0.27, 0.38); p=0.743 |
Day 56# | | | |
Patients with analysable data | 497 | 492 | |
Change from baseline | 1.67±0.117 | 1.48±0.118 | 0.19 (−0.14, 0.51); p=0.261 |
Day 84# | | | |
Patients with analysable data | 491 | 486 | |
Change from baseline | 1.74±0.116 | 1.66±0.116 | 0.08 (−0.24, 0.40); p=0.636 |
TDI responders | | | |
Day 28¶ | | | Odds ratio |
Total patients | 515 | 514 | |
Responders | 266 (52) | 260 (51) | 1.05 (0.82, 1.36); p=0.694 |
Day 56¶ | | | |
Total patients | 515 | 515 | |
Responders | 289 (56) | 249 (48) | 1.44 (1.11, 1.88); p=0.007+ |
Day 84¶ | | | |
Total patients | 515 | 515 | |
Responders | 280 (54) | 268 (52) | 1.12 (0.87, 1.46); p=0.379 |
SGRQ total score | | | |
Day 28# | | | Difference |
Patients with analysable data | 491 | 479 | |
Change from baseline | −4.16±0.467 | −4.13±0.472 | −0.03 (−1.33, −1.28); p=0.970 |
Day 84# | | | |
Patients with analysable data | 477 | 466 | |
Change from baseline | −4.75±0.545 | −4.11±0.551 | −0.64 (−2.17, 0.88); p=0.406 |
SGRQ responders | | | |
Day 28¶ | | | Odds ratio |
Total patients | 504 | 497 | |
Responders | 218 (43) | 224 (45) | 0.94 (0.73, 1.22); p=0.660 |
Day 84¶ | | | |
Total patients | 508 | 503 | |
Responders | 221 (44) | 230 (46) | 0.92 (0.72, 1.19); p=0.541 |
CAT score | | | |
Day 28# | | | Difference |
Patients with analysable data | 503 | 500 | |
Change from baseline | −1.29±0.226 | −1.27±0.226 | −0.02 (−0.65, 0.61); p=0.949 |
Day 84# | | | |
Patients with analysable data | 494 | 488 | |
Change from baseline | −1.70±0.254 | −1.19±0.256 | −0.51 (−1.22, 0.19); p=0.156 |
CAT responders | | | |
Day 28¶ | | | Odds Ratio |
Total patients | 516 | 518 | |
Responders | 227 (44) | 251 (48) | 0.85 (0.66, 1.09); p=0.199 |
Day 84¶ | | | |
Total patients | 516 | 518 | |
Responders | 237 (46) | 249 (48) | 0.94 (0.73, 1.21); p=0.630 |