1 All‐cause mortality |
18 |
8752 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.88 [0.81, 4.36] |
1.1 IND/GLY 110/50 |
5 |
2020 |
Odds Ratio (M‐H, Fixed, 95% CI) |
2.53 [0.61, 10.49] |
1.2 UMEC/VI 62.5/25 |
5 |
1921 |
Odds Ratio (M‐H, Fixed, 95% CI) |
3.12 [0.68, 14.36] |
1.3 UMEC/VI 125/25 |
4 |
1401 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.14 [0.01, 2.83] |
1.4 UMEC/VI 500/25 |
1 |
51 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
1.5 TIO/OLO 2.5/5 |
6 |
1670 |
Odds Ratio (M‐H, Fixed, 95% CI) |
2.53 [0.12, 53.43] |
1.6 TIO/OLO 5/5 |
6 |
1689 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
2 SAEs |
22 |
10536 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.06 [0.88, 1.28] |
2.1 IND/GLY 110/50 |
6 |
2830 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.16 [0.86, 1.56] |
2.2 UMEC/VI 62.5/25 |
6 |
2317 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.29 [0.86, 1.93] |
2.3 UMEC/VI 125/25 |
4 |
1403 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.75 [0.46, 1.22] |
2.4 UMEC/VI 500/25 |
1 |
51 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
2.5 TIO/OLO 2.5/5 |
6 |
1670 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.90 [0.49, 1.68] |
2.6 TIO/OLO 5/5 |
7 |
1840 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.97 [0.55, 1.73] |
2.7 ACM/FOR 200/6 |
1 |
141 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.51 [0.02, 12.96] |
2.8 ACM/FOR 200/12 |
1 |
140 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.51 [0.02, 13.07] |
2.9 ACM/FOR 200/18 |
1 |
144 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.11 [0.06, 22.41] |
3 AECOPD |
3 |
1127 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.53 [0.36, 0.78] |
3.1 UMEC/VI 62.5/25 |
2 |
786 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.58 [0.37, 0.93] |
3.2 UMEC/VI 125/25 |
1 |
290 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.37 [0.17, 0.78] |
3.3 UMEC/VI 500/25 |
1 |
51 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.68 [0.08, 35.43] |
4 Time to first AECOPD |
2 |
1371 |
Hazard Ratio (Fixed, 95% CI) |
0.44 [0.31, 0.63] |
4.1 UMEC/VI 125/25 |
2 |
1371 |
Hazard Ratio (Fixed, 95% CI) |
0.44 [0.31, 0.63] |
5 Difference vs placebo in adjusted SGRQ score (HRQoL) |
8 |
4952 |
Mean Difference (Fixed, 95% CI) |
‐4.08 [‐4.80, ‐3.36] |
5.1 IND/GLY 110/50 |
2 |
1370 |
Mean Difference (Fixed, 95% CI) |
‐3.88 [‐5.30, ‐2.45] |
5.2 UMEC/VI 62.5/25 |
3 |
1425 |
Mean Difference (Fixed, 95% CI) |
‐4.25 [‐5.73, ‐2.77] |
5.3 UMEC/VI 125/25 |
2 |
1000 |
Mean Difference (Fixed, 95% CI) |
‐3.64 [‐5.48, ‐1.80] |
5.4 TIO/OLO 2.5/5 |
2 |
579 |
Mean Difference (Fixed, 95% CI) |
‐3.89 [‐5.60, ‐2.17] |
5.5 TIO/OLO 5/5 |
2 |
578 |
Mean Difference (Fixed, 95% CI) |
‐4.72 [‐6.43, ‐3.01] |
6 SGRQ responder analysis |
7 |
4258 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.75 [1.54, 1.99] |
6.1 IND/GLY 110/50 |
1 |
706 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.35 [0.98, 1.86] |
6.2 TIO/OLO 2.5/5 |
2 |
579 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.87 [1.30, 2.70] |
6.3 TIO/OLO 5/5 |
2 |
578 |
Odds Ratio (M‐H, Fixed, 95% CI) |
2.35 [1.63, 3.40] |
6.4 UMEC/VI 62.5/25 |
3 |
1441 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.70 [1.37, 2.12] |
6.5 UMEC/VI 125/25 |
2 |
954 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.78 [1.35, 2.34] |
7 Difference vs placebo in adjusted trough FEV1 at EOT |
13 |
6598 |
Mean Difference (Fixed, 95% CI) |
0.20 [0.19, 0.21] |
7.1 IND/GLY 110/50 |
2 |
1018 |
Mean Difference (Fixed, 95% CI) |
0.25 [0.22, 0.28] |
7.2 UMEC/VI 62.5/25 |
6 |
2158 |
Mean Difference (Fixed, 95% CI) |
0.18 [0.17, 0.20] |
7.3 UMEC/VI 125/25 |
4 |
1304 |
Mean Difference (Fixed, 95% CI) |
0.22 [0.20, 0.25] |
7.4 TIO/OLO 2.5/5 |
3 |
845 |
Mean Difference (Fixed, 95% CI) |
0.18 [0.15, 0.20] |
7.5 TIO/OLO 5/5 |
3 |
859 |
Mean Difference (Fixed, 95% CI) |
0.21 [0.18, 0.23] |
7.6 ACLID/FORM 200/6 |
1 |
137 |
Mean Difference (Fixed, 95% CI) |
0.07 [‐0.04, 0.18] |
7.7 ACLID/FORM 200/12 |
1 |
137 |
Mean Difference (Fixed, 95% CI) |
0.12 [0.01, 0.22] |
7.8 ACLID/FORM 200/18 |
1 |
140 |
Mean Difference (Fixed, 95% CI) |
0.08 [‐0.04, 0.19] |
8 Difference vs placebo in trough FEV1 at EOT |
5 |
2330 |
Mean Difference (Fixed, 95% CI) |
0.18 [0.16, 0.20] |
8.1 IND/GLY 110/50 |
3 |
1139 |
Mean Difference (Fixed, 95% CI) |
0.20 [0.17, 0.22] |
8.2 TIO/OLO 2.5/5 |
2 |
596 |
Mean Difference (Fixed, 95% CI) |
0.16 [0.13, 0.19] |
8.3 TIO/OLO 5/5 |
2 |
595 |
Mean Difference (Fixed, 95% CI) |
0.16 [0.13, 0.20] |
9 Difference vs placebo in trough FEV1 ‐ pooled adjusted and EOT analyses |
18 |
|
Mean Difference (Fixed, 95% CI) |
0.20 [0.19, 0.20] |
9.1 IND/GLY 110/50 |
5 |
|
Mean Difference (Fixed, 95% CI) |
0.22 [0.21, 0.24] |
9.2 UMEC/VI 125/25 |
4 |
|
Mean Difference (Fixed, 95% CI) |
0.22 [0.20, 0.25] |
9.3 UMEC/VI 62.5/25 |
6 |
|
Mean Difference (Fixed, 95% CI) |
0.18 [0.17, 0.20] |
9.4 TIO/OLO 2.5/5 |
5 |
|
Mean Difference (Fixed, 95% CI) |
0.17 [0.15, 0.19] |
9.5 TIO/OLO 5/5 |
5 |
|
Mean Difference (Fixed, 95% CI) |
0.19 [0.17, 0.21] |
9.6 ACLID/FORM 200/6 |
1 |
|
Mean Difference (Fixed, 95% CI) |
0.07 [‐0.04, 0.18] |
9.7 ACLID/FORM 200/12 |
1 |
|
Mean Difference (Fixed, 95% CI) |
0.12 [0.01, 0.22] |
9.8 ACLID/FORM 200/18 |
1 |
|
Mean Difference (Fixed, 95% CI) |
0.08 [‐0.04, 0.19] |
10 Difference vs placebo in adjusted peak FEV1 |
7 |
4188 |
Mean Difference (Fixed, 95% CI) |
0.31 [0.29, 0.32] |
10.1 IND/GLY 110/50 |
2 |
1094 |
Mean Difference (Fixed, 95% CI) |
0.35 [0.32, 0.38] |
10.2 UMEC/VI 62.5/25 |
1 |
693 |
Mean Difference (Fixed, 95% CI) |
0.22 [0.18, 0.27] |
10.3 UMEC/VI 125/25 |
1 |
678 |
Mean Difference (Fixed, 95% CI) |
0.28 [0.24, 0.32] |
10.4 TIO/OLO 2.5/5 |
2 |
644 |
Mean Difference (Fixed, 95% CI) |
0.29 [0.27, 0.32] |
10.5 TIO/OLO 5/5 |
2 |
656 |
Mean Difference (Fixed, 95% CI) |
0.33 [0.30, 0.35] |
10.6 ACLID/FORM 200/6 |
1 |
140 |
Mean Difference (Fixed, 95% CI) |
0.25 [0.13, 0.37] |
10.7 ACLID/FORM 200/12 |
1 |
139 |
Mean Difference (Fixed, 95% CI) |
0.31 [0.20, 0.43] |
10.8 ACLID/FORM 200/18 |
1 |
144 |
Mean Difference (Fixed, 95% CI) |
0.31 [0.19, 0.42] |
11 AEs |
17 |
8235 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.95 [0.86, 1.04] |
11.1 IND/GLY 110/50 |
6 |
2830 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.90 [0.76, 1.07] |
11.2 UMEC/VI 62.5/25 |
5 |
1921 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.07 [0.88, 1.29] |
11.3 UMEC/VI 125/25 |
4 |
1401 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.08 [0.86, 1.34] |
11.4 UMEC/VI 500/25 |
1 |
51 |
Odds Ratio (M‐H, Fixed, 95% CI) |
2.84 [0.32, 25.36] |
11.5 TIO/OLO 2.5/5 |
4 |
1011 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.85 [0.66, 1.11] |
11.6 TIO/OLO 5/5 |
4 |
1021 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.78 [0.60, 1.01] |