ECG characteristic | Day 1 predose (0 h) for treatment group | P value | Day 2 postdose (28 h) for treatment group | P value | Mean % difference for groups | P value | |||
---|---|---|---|---|---|---|---|---|---|

DHA-PIP (n = 47) | Placebo (n = 22) | DHA-PIP (n = 47) | Placebo (n = 22) | DHA-PIP (n = 47) | Placebo (n = 22) | ||||

ECG findings, N (%) | |||||||||

Normal sinus rhythm | 84 (59.6) | 31 (47.0) | 0.089 | 172 (61.0) | 73(55.3) | 0.272 | |||

Sinus arrhythmia | 9 (6.4) | 6 (9.1) | 0.484 | 7 (2.50) | 6 (4.56) | 0.262 | |||

Sinus tachycardia | 0 (0) | 0 (0) | 0 (0) | 0 (0) | |||||

Sinus bradycardia | 41 (29.1) | 26 (39.4) | 0.140 | 16 (27.0) | 44 (33.3) | 0.182 | |||

Early repolarization | 24 (17.0) | 17 (25.8) | 0.142 | 34 (12.1) | 34 (25.8) | <0.001 | |||

Hypertrophy by voltage criteria | 31 (22.0) | 27 (41.0) | 0.005 | 67 (23.8) | 43 (32.6) | 0.058 | |||

ECG intervals,^{b} mean (SD) | |||||||||

Heart rate | 67 (8.4) | 65 (8.2) | 0.438 | 63 (7) | 66 (10) | 0.181 | −5.5 | 0.6 | 0.005 |

QT interval (manual) | 375 (25) | 380 (29) | 0.519 | 432 (33) | 382 (26) | <0.001 | 15.1 | 0.9 | <0.001 |

QTcF interval | |||||||||

QTcFm | 390 (19) | 390 (19) | 0.685 | 441 (27) | 395 (15) | <0.001 | 13.3 | 1.4 | <0.001 |

QTcFe | 413 (13) | 414 (15) | 0.762 | 456 (25) | 414 (16) | <0.001 | 10.4 | −0.08 | <0.001 |

QTcB interval | |||||||||

QTcBm | 398 (20) | 396 (18) | 0.843 | 445 (27) | 402 (17) | <0.001 | 12.3 | 1.5 | <0.001 |

QTcBe | 418 (15) | 417 (17) | 0.910 | 457 (27) | 418 (19) | <0.001 | 9.4 | 0.05 | <0.001 |

↵a The values for ECG characteristics are shown for groups given dihydroartemisinin-piperaquine (DHA-PIP) or placebo at day predose (0 h) and day 2 postdose (28 h). The

*P*values for the differences in the values for the two groups at different time points are shown. The values that were significantly different for two groups are shown in boldface type.*n*is the total number of cases.*N*is the total number of all tracings because three tracings were done at each time point.↵b Intervals averaged over three ECG readings per volunteer at each time point.