Supplementary Table 2. Comparison of Cmax across study 1, study 2, and the exploratory analyses of study 2.
| Treatment | Treatment comparisona | Treatment ratio (90% CI for ratio) | ||
|---|---|---|---|---|
| Study 1 (CTT116415) | Study 2 (200587) original analysis |
Study 2 (200587) exploratory analysis |
||
| FF | FF/UMEC(500)/VI vs. FF/UMEC(250)/VI | ND | 1.006 (0.927 – 1.092) | 0.967 (0.889 – 1.052) |
| FF/UMEC(500)/VI vs. FF/VI | 1.233 (1.144 – 1.328) | 0.952 (0.877 – 1.033) | 0.909 (0.836 – 0.989) | |
| FF/UMEC(250)/VI vs. FF/VI | ND | 0.946 (0.872 – 1.026) | 0.940 (0.864 – 1.023) | |
| UMEC | FF/UMEC(500)/VI vs. FF/UMEC(250)/VI | ND | 1.040 (0.960 – 1.127) | 1.014 (0.933 – 1.101) |
| FF/UMEC(250)/VI vs. UMEC(250)/VI | ND | 0.983 (0.908 – 1.066) | 1.000 (0.920 – 1.086) | |
| VI | FF/UMEC(500)/VI vs. FF/UMEC(250)/VI | ND | 1.095 (1.038 – 1.155) | 1.157 (1.077 – 1.243) |
| FF/UMEC(500)/VI vs. FF/VI | 1.463 (1.376 – 1.556) | 1.162 (1.102 – 1.226) | 1.287 (1.198 – 1.382) | |
| FF/UMEC(250)/VI vs. FF/VI | ND | 1.061 (1.006 – 1.120) | 1.112 (1.036 – 1.195) | |
| FF/UMEC(250)/VI vs. UMEC(250)/VI | ND | 1.205 (1.142 – 1.271) | 1.250 (1.164 – 1.343) | |
aTotal dose as 4 consecutive doses: 400 μg FF, 500 μg or 250 μg UMEC, and 100 μg VI. ND = analysis not done (there is no comparison as the lower UMEC dose was not evaluated in study 1).