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. 2016 May 5;77:1275–1283. doi: 10.1007/s00280-016-3031-9

Table 2.

Comparison of least square mean placebo-adjusted change from baseline in 12-lead Holter QTcI (ms) between TAS-102 and placebo

Day Postdose hour TAS-102 Placebo TAS-102 versus placebo
N LS meansa N LS meansa Difference 90 % CI
1 0 27 −1.9 27 −0.3 −1.6 (−5.6, 2.4)
0.25 27 −0.9 28 −1.6 0.7 (−3.3, 4.7)
0.5 29 −1.3 28 −4.0 2.7 (−1.2, 6.6)
1 29 −2.0 29 −2.2 0.2 (−3.7, 4.1)
2 28 −0.9 30 −0.6 −0.3 (−4.2, 3.6)
4 30 2.2 27 −1.9 4.1 (0.2, 8.1)
6 28 −3.4 29 −2.6 −0.8 (−4.8, 3.1)
8 28 −1.5 25 −3.3 1.8 (−2.3, 5.9)
10 28 −1.3 28 −3.5 2.2 (−1.7, 6.2)
12 21 −0.1 15 −4.9 4.8 (−0.3, 9.8)
12 0 26 −0.9 27 −0.4 −0.5 (−5.6, 4.5)
0.25 28 −1.3 28 −1.6 0.3 (−4.6, 5.2)
0.5 29 −1.8 28 −3.6 1.8 (−3.1, 6.7)
1 29 −3.3 29 −2.1 −1.1 (−6.0, 3.7)
2 28 −2.1 30 −0.6 −1.5 (−6.3, 4.4)
4 29 −0.4 27 −1.4 1.0 (−3.9, 5.9)
6 30 −3.4 29 −2.5 −1.0 (−5.7, 3.8)
8 27 0.3 25 −3.3 3.6 (−1.5, 8.7)
10 26 −3.9 28 −3.3 −0.7 (−5.7, 4.3)
12 19 0.2 15 −3.7 3.9 (−2.5, 10.3)

LS least square; CI confidence interval

aRepeated measures analysis of variance (ANOVA) model: change from baseline in QTcI result = Treatment + Time + Treatment × Time. Compound symmetry covariance was used. Measurements at different time points within each patient’s treatment were treated as repeated measures