1 All‐cause mortality |
14 |
7287 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.65 [0.60, 4.50] |
1.1 IND/GLY 110/50 |
4 |
1682 |
Odds Ratio (M‐H, Fixed, 95% CI) |
2.97 [0.47, 18.97] |
1.2 TIO/OLO 2.5/5 |
6 |
1670 |
Odds Ratio (M‐H, Fixed, 95% CI) |
2.53 [0.12, 53.43] |
1.3 TIO/OLO 5/5 |
6 |
1689 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.0 [0.0, 0.0] |
1.4 UMEC/VI 62.5/25 |
3 |
1135 |
Odds Ratio (M‐H, Fixed, 95% CI) |
3.22 [0.38, 27.52] |
1.5 UMEC/VI 125/25 |
3 |
1111 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.14 [0.01, 2.83] |
2 SAEs |
17 |
8448 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.09 [0.86, 1.40] |
2.1 IND/GLY 110/50 |
5 |
2020 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.23 [0.79, 1.89] |
2.2 TIO/OLO 2.5/5 |
6 |
1670 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.90 [0.49, 1.68] |
2.3 TIO/OLO 5/5 |
6 |
1689 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.02 [0.54, 1.91] |
2.4 UMEC/VI 62.5/25 |
4 |
1531 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.34 [0.75, 2.40] |
2.5 UMEC/VI 125/25 |
3 |
1113 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.95 [0.55, 1.66] |
2.6 ACM/FOR 200/6 |
1 |
141 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.51 [0.02, 12.96] |
2.7 ACM/FOR 200/12 |
1 |
140 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.51 [0.02, 13.07] |
2.8 ACM/FOR 200/18 |
1 |
144 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.11 [0.06, 22.41] |
3 Time to first AECOPD |
2 |
|
Hazard Ratio (Fixed, 95% CI) |
0.44 [0.31, 0.63] |
3.1 UMEC/VI 125/25 |
2 |
|
Hazard Ratio (Fixed, 95% CI) |
0.44 [0.31, 0.63] |
4 Difference vs placebo in adjusted SGRQ score (HRQoL) |
5 |
|
Mean Difference (Fixed, 95% CI) |
‐4.12 [‐4.99, ‐3.24] |
4.1 IND/GLY 110/50 |
1 |
|
Mean Difference (Fixed, 95% CI) |
‐3.01 [‐5.05, ‐0.97] |
4.2 UMEC/VI 125/25 |
1 |
|
Mean Difference (Fixed, 95% CI) |
‐3.60 [‐5.76, ‐1.44] |
4.3 UMEC/VI 62.5/25 |
1 |
|
Mean Difference (Fixed, 95% CI) |
‐5.51 [‐7.88, ‐3.14] |
4.4 TIO/OLO 2.5/5 |
2 |
|
Mean Difference (Fixed, 95% CI) |
‐3.89 [‐5.60, ‐2.17] |
4.5 TIO/OLO 5/5 |
2 |
|
Mean Difference (Fixed, 95% CI) |
‐4.72 [‐6.43, ‐3.01] |
5 SGRQ responder analysis |
5 |
3234 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.81 [1.56, 2.10] |
5.1 IND/GLY 110/50 |
1 |
706 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.35 [0.98, 1.86] |
5.2 TIO/OLO 2.5/5 |
2 |
579 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.87 [1.30, 2.70] |
5.3 TIO/OLO 5/5 |
2 |
578 |
Odds Ratio (M‐H, Fixed, 95% CI) |
2.35 [1.63, 3.40] |
5.4 UMEC/VI 62.5/25 |
1 |
693 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.88 [1.37, 2.59] |
5.5 UMEC/VI 125/25 |
1 |
678 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.83 [1.32, 2.54] |
6 Difference vs placebo in adjusted trough FEV1 at EOT |
10 |
|
Mean Difference (Fixed, 95% CI) |
0.20 [0.19, 0.22] |
6.1 IND/GLY 110/50 |
1 |
|
Mean Difference (Fixed, 95% CI) |
0.28 [0.24, 0.32] |
6.2 UMEC/VI 125/25 |
3 |
|
Mean Difference (Fixed, 95% CI) |
0.22 [0.20, 0.25] |
6.3 UMEC/VI 62.5/25 |
4 |
|
Mean Difference (Fixed, 95% CI) |
0.20 [0.18, 0.22] |
6.4 TIO/OLO 2.5/5 |
3 |
|
Mean Difference (Fixed, 95% CI) |
0.18 [0.15, 0.20] |
6.5 TIO/OLO 5/5 |
3 |
|
Mean Difference (Fixed, 95% CI) |
0.21 [0.18, 0.23] |
6.6 ACLID/FORM 200/6 |
1 |
|
Mean Difference (Fixed, 95% CI) |
0.07 [‐0.04, 0.18] |
6.7 ACLID/FORM 200/12 |
1 |
|
Mean Difference (Fixed, 95% CI) |
0.12 [0.01, 0.22] |
6.8 ACLID/FORM 200/18 |
1 |
|
Mean Difference (Fixed, 95% CI) |
0.08 [‐0.04, 0.19] |
7 Difference vs placebo in trough FEV1 at EOT |
4 |
|
Mean Difference (Fixed, 95% CI) |
0.18 [0.16, 0.20] |
7.1 IND/GLY 110/50 |
2 |
|
Mean Difference (Fixed, 95% CI) |
0.2 [0.17, 0.23] |
7.2 TIO/OLO 2.5/5 |
2 |
|
Mean Difference (Fixed, 95% CI) |
0.16 [0.13, 0.19] |
7.3 TIO/OLO 5/5 |
2 |
|
Mean Difference (Fixed, 95% CI) |
0.16 [0.13, 0.20] |
8 Difference vs placebo in adjusted peak FEV1 |
7 |
|
Mean Difference (Fixed, 95% CI) |
0.31 [0.29, 0.32] |
8.1 IND/GLY 110/50 |
2 |
|
Mean Difference (Fixed, 95% CI) |
0.35 [0.32, 0.38] |
8.2 UMEC/VI 125/25 |
1 |
|
Mean Difference (Fixed, 95% CI) |
0.28 [0.24, 0.32] |
8.3 UMEC/VI 62.5/25 |
1 |
|
Mean Difference (Fixed, 95% CI) |
0.22 [0.18, 0.27] |
8.4 TIO/OLO 2.5/5 |
2 |
|
Mean Difference (Fixed, 95% CI) |
0.29 [0.27, 0.32] |
8.5 TIO/OLO 5/5 |
2 |
|
Mean Difference (Fixed, 95% CI) |
0.33 [0.30, 0.35] |
8.6 ACLID/FORM 200/6 |
1 |
|
Mean Difference (Fixed, 95% CI) |
0.25 [0.13, 0.37] |
8.7 ACLID/FORM 200/12 |
1 |
|
Mean Difference (Fixed, 95% CI) |
0.31 [0.20, 0.43] |
8.8 ACLID/FORM 200/18 |
1 |
|
Mean Difference (Fixed, 95% CI) |
0.31 [0.19, 0.42] |
9 AEs |
11 |
5579 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.97 [0.86, 1.08] |
9.1 IND/GLY 110/50 |
3 |
1301 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.92 [0.70, 1.19] |
9.2 TIO/OLO 2.5/5 |
4 |
1011 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.85 [0.66, 1.11] |
9.3 TIO/OLO 5/5 |
4 |
1021 |
Odds Ratio (M‐H, Fixed, 95% CI) |
0.78 [0.60, 1.01] |
9.4 UMEC/VI 62.5/25 |
3 |
1135 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.14 [0.89, 1.46] |
9.5 UMEC/VI 125/25 |
3 |
1111 |
Odds Ratio (M‐H, Fixed, 95% CI) |
1.15 [0.90, 1.48] |
10 Difference vs placebo in trough FEV1 ‐ pooled adjusted and EOT analyses |
14 |
|
Mean Difference (Fixed, 95% CI) |
0.20 [0.20, 0.21] |
10.1 IND/GLY 110/50 |
3 |
|
Mean Difference (Fixed, 95% CI) |
0.22 [0.20, 0.25] |
10.2 UMEC/VI 125/25 |
3 |
|
Mean Difference (Fixed, 95% CI) |
0.22 [0.20, 0.25] |
10.3 UMEC/VI 62.5/25 |
4 |
|
Mean Difference (Fixed, 95% CI) |
0.20 [0.18, 0.22] |
10.4 TIO/OLO 2.5/5 |
5 |
|
Mean Difference (Fixed, 95% CI) |
0.20 [0.20, 0.20] |
10.5 TIO/OLO 5/5 |
5 |
|
Mean Difference (Fixed, 95% CI) |
0.21 [0.20, 0.21] |
10.6 ACLID/FORM 200/6 |
1 |
|
Mean Difference (Fixed, 95% CI) |
0.07 [‐0.04, 0.18] |
10.7 ACLID/FORM 200/12 |
1 |
|
Mean Difference (Fixed, 95% CI) |
0.12 [0.01, 0.22] |
10.8 ACLID/FORM 200/18 |
1 |
|
Mean Difference (Fixed, 95% CI) |
0.08 [‐0.04, 0.19] |