Analysis | Population | Data included in analysis | CDPI | TIS | Adjusted mean difference between groups in FEV1 % from baseline# | Lower limit of 95% CI¶ | Upper limit of 95% CI | Satisfies non-inferiority? |
ANCOVA analysis on the original absolute scale | ITT | LOCF | 183 | 190 | -1.16 | -3.15 | 0.84 | No |
Completers | 153 | 171 | -0.43 | -2.59 | 1.72 | Yes | ||
PP | LOCF | 141 | 157 | -1.49 | -3.79 | 0.81 | No | |
Completers | 120 | 141 | -0.99 | -3.48 | 1.51 | No | ||
Logarithmic analysis | ITT | LOCF | 183 | 190 | -0.98 | -2.74 | 0.86 | Yes |
Completers | 153 | 171 | -0.29 | -2.20 | 1.70 | Yes | ||
PP | LOCF | 141 | 157 | -1.10 | -3.08 | 0.97 | No | |
Completers | 120 | 141 | -0.56 | -2.71 | 1.70 | Yes | ||
Non-parametric analysis | ITT | LOCF | 183 | 190 | -0.56+ | -2.16+ | NR | Yes |
Completers | 153 | 171 | 0.05+ | -1.61+ | NR | Yes | ||
PP | LOCF | 141 | 157 | -0.67+ | -2.57+ | NR | Yes | |
Completers | 120 | 141 | -0.15+ | -2.14+ | NR | Yes |
Data are presented as n or %. Bold denotes protocol-defined analyses. CDPI: colistimethate sodium dry powder for inhalation; TIS: tobramycin inhaled solution; ITT: intention-to-treat; PP: per protocol; LOCF: last observation carried forward; NR: not reported. #: adjusted for baseline FEV1 % and pooled centre; ¶: this should no lower than -3% to satisfy non-inferiority criteria; +: median difference, CI determined using distribution-free methods based on the Wilcoxon rank sum test, without adjustment for pooled centre; unclear if adjusted for baseline FEV1 %.