TABLE 2.
Baseline ECG parameters (QT/QTc analysis set)
| Napabucasin (mg) |
Placebo (N = 12) |
||||
|---|---|---|---|---|---|
|
240 mg (N = 9) |
480 mg (N = 9) |
720 mg (N = 9) |
1200 mg (N = 9) |
||
| HR (bpm) | |||||
| Mean (SD) | 56.4 (5.1) | 62.7 (6.2) | 58.5 (6.0) | 59.6 (7.0) | 57.5 (5.6) |
| SE | 1.7 | 2.1 | 2 | 2.3 | 1.6 |
| 90% CI | (53.2–59.5) | (58.9–66.5) | (54.7–62.2) | (55.3–64.0) | (54.6–60.4) |
| Median (range) | 54.6 (51–66) | 63.7 (52–70) | 60.6 (51–67) | 60.3 (46–68) | 56.2 (49–66) |
| QTcF (ms) | |||||
| Mean (SD) | 401.1 (15.1) | 393.3 (20.9) | 398.9 (20.1) | 403.7 (18.2) | 404.6 (21.3) |
| SE | 5 | 7 | 6.7 | 6.1 | 6.2 |
| 90% CI | (391.8–410.5) | (380.3–406.3) | (386.4–411.4) | (392.4–414.9) | (393.5–415.7) |
| Median (range) | 405.5 (381–426) | 390.9 (353–426) | 392.8 (372–429) | 395.7 (384–434) | 398.3 (371–435) |
| PR (ms) | |||||
| Mean (SD) | 143.9 (26.7) | 149.2 (17.6) | 150.7 (19.7) | 145.6 (21.2) | 158.9 (17.5) |
| SE | 8.9 | 5.9 | 6.6 | 7.1 | 5.1 |
| 90% CI | (127.4–160.5) | (138.3–160.1) | (138.4–162.9) | (132.5–158.7) | (149.9–168.0) |
| Median (range) | 143.8 (111–200) | 147.2 (110–168) | 150.7 (121–175) | 136.1 (120–179) | 151.7 (132–189) |
| QRS (ms) | |||||
| Mean (SD) | 106.4 (5.7) | 105.5 (2.9) | 106.0 (5.6) | 107.6 (7.5) | 104.3 (4.5) |
| SE | 1.9 | 1 | 1.9 | 2.5 | 1.3 |
| 90% CI | (102.9–110.0) | (103.7–107.4) | (102.6–109.5) | (102.9–112.2) | (102.0–106.7) |
| Median (range) | 106.3 (99–114) | 104.9 (101–110) | 104.8 (100–115) | 104.7 (102–124) | 103.8 (97–113) |
Abbreviations: CI, confidence interval; ECG, electrocardiogram; HR, heart rate; QTc, QT interval corrected for heart rate; QTcF, QT interval corrected for heart rate using Fridericia's formula; SD, standard deviation; SE, standard error.