TABLE 4

Statistical analysis of comparisons for mean maximal changes in QTcF from baseline

Treatment comparisonLS mean maximal change from baseline (ms)aLS estimate of difference (90% CI) (ms)P
75 mg KAE609 + 320 mg PPQ25 mg KAE609 + 1,280 mg PPQ320 mg PPQ1,280 mg PPQ1,280 mg PPQ + 25 mg KAE60925 mg KAE609
75 mg KAE609 + 320 mg PPQ vs 320 mg PPQ5.045.90−0.86 (−4.41 to 2.68)0.6864
25 mg KAE609 + 1,280 mg PPQ vs 1,280 mg PPQ9.507.122.37 (−2.08 to 6.82)0.3775
25 mg KAE609 + 1,280 mg PPQ vs 25 mg KAE60911.203.707.47 (3.55–11.4)0.0025
  • a At predosing and 2, 4, 8, 12, and 24 h postdosing, triplicate ECG assessments were available. Averages of triplicate assessments were calculated, and the values for baseline and changes from baseline were derived accordingly. The repeated measurements were not taken into account for the calculation of statistics. The maximal changes from baseline for ECG intervals of less than 24 h were analyzed using a linear fixed-effects model with treatment as a fixed effect and KAE609 and PPQ concentrations at maximal changes as covariates. LS, least-squares.