Table 2.
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