Table 2.
Summary statistics for change from baseline of QTcF interval (pharmacodynamic analysis set)
Cycle | Days | Time point | N | Mean (SD) ms | Median ms | Min:Max Ms | Q1:Q3 ms | 90 % CI ms |
---|---|---|---|---|---|---|---|---|
1 | 1 | Predose | 31 | 1.7 (15.5) | −0.3 | −30.3:45.7 | −8.3:8.0 | −3.0:6.4 |
0.5 | 32 | 2.3 (10.1) | 2.7 | −25.3:23.0 | −5.2:9.5 | −0.8:5.3 | ||
1 | 32 | −0.5 (11.4) | −2.0 | −18.0:27.7 | −9.7:4.8 | −4.0:2.9 | ||
1.5 | 32 | 0.2 (14.3) | −0.3 | −23.7:27.7 | −10.7:11.3 | −4.1:4.5 | ||
2 | 32 | −1.7 (10.0) | −2.0 | −20.0:19.0 | −8.5:5.3 | −4.6:1.3 | ||
3 | 31 | −2.9 (12.0) | −5.3 | −24.3:20.7 | −12.7:5.7 | −6.5:0.8 | ||
4 | 31 | −3.0 (8.0) | −1.0 | −20.3:11.7 | −7.3:2.3 | −5.4:−0.6 | ||
6 | 31 | 1.4 (13.0) | 1.0 | −35.0:21.7 | −7.7:14.7 | −2.5:5.4 | ||
8 | 32 | −1.4 (13.1) | −1.3 | −44.0:22.7 | −9.3:6.2 | −5.3:2.5 | ||
12 | 31 | 0.3 (11.9) | 4.0 | −37.7:22.0 | −7.0:6.7 | −3.4:3.9 | ||
24 | 28 | −6.0 (9.7) | −5.2 | −37.0:6.7 | −8.5:−1.2 | −9.1:−2.9 | ||
2 | 1 | Predose | 29 | −3.4 (13.2) | −3.3 | −38.7:18.3 | −13.3:6.7 | −7.6:0.8 |
0.5 | 32 | −3.1 (11.8) | −3.2 | −32.0:18.3 | −9.7:5.7 | −6.6:0.5 | ||
1 | 33 | −1.7 (13.9) | 0.0 | −31.7:20.3 | −11.3:9.0 | −5.8:2.4 | ||
1.5 | 33 | −4.2 (15.6) | −1.0 | −37.7:34.0 | −13.7:4.0 | −8.8:0.4 | ||
2 | 33 | −4.7 (12.1) | −3.3 | −27.0:19.7 | −14.0:4.0 | −8.3:−1.1 | ||
3 | 33 | −5.0 (15.4) | −2.0 | −42.0:19.0 | −15.7:7.3 | −9.6:−0.5 | ||
4 | 32 | −6.2 (14.4) | −5.3 | −30.3:28.7 | −17.7:3.3 | −10.5:−1.9 | ||
6 | 30 | −3.1 (17.6) | −6.2 | −42.0:27.0 | −12.0:9.3 | −8.6:2.4 | ||
8 | 32 | −3.1 (16.0) | −6.2 | −37.0:35.7 | −12.5:7.7 | −7.9:1.7 | ||
12 | 33 | −2.9 (11.2) | −4.7 | −21.7:23.3 | −9.0:4.3 | −6.2:0.4 | ||
24 | 29 | −11.9 (14.2) | −12.7 | −38.0:21.7 | −20.7:−3.7 | −16.4:−7.4 |