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. 2019 Mar 6;2019(3):CD012930. doi: 10.1002/14651858.CD012930.pub2

Comparison 5. Sensitivity analysis ‐ RoB.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
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]