TABLE 2

Baseline and postdose ECG findings per treatment group during month 1a

ECG characteristicDay 1 predose (0 h) for treatment groupP valueDay 2 postdose (28 h) for treatment groupP valueMean % difference for groupsP 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 rhythm84 (59.6)31 (47.0)0.089172 (61.0)73(55.3)0.272
    Sinus arrhythmia9 (6.4)6 (9.1)0.4847 (2.50)6 (4.56)0.262
    Sinus tachycardia0 (0)0 (0)0 (0)0 (0)
    Sinus bradycardia41 (29.1)26 (39.4)0.14016 (27.0)44 (33.3)0.182
    Early repolarization24 (17.0)17 (25.8)0.14234 (12.1)34 (25.8)<0.001
    Hypertrophy by voltage criteria31 (22.0)27 (41.0)0.00567 (23.8)43 (32.6)0.058
ECG intervals,b mean (SD)
    Heart rate67 (8.4)65 (8.2)0.43863 (7)66 (10)0.181−5.50.60.005
    QT interval (manual)375 (25)380 (29)0.519432 (33)382 (26)<0.00115.10.9<0.001
    QTcF interval
        QTcFm390 (19)390 (19)0.685441 (27)395 (15)<0.00113.31.4<0.001
        QTcFe413 (13)414 (15)0.762456 (25)414 (16)<0.00110.4−0.08<0.001
    QTcB interval
        QTcBm398 (20)396 (18)0.843445 (27)402 (17)<0.00112.31.5<0.001
        QTcBe418 (15)417 (17)0.910457 (27)418 (19)<0.0019.40.05<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.