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Table 4 ECG after treatment administration: QTcB and QTcF (continuous parameter in ms)—Safety, QTcF/QTcB and strict QTcF/QTcB population

From: Longitudinal study based on a safety registry for malaria patients treated with artenimol–piperaquine in six European countries

  Safety population QTcF/QTcB population Strict QTcF/QTcB population
N = 294 N = 143 N = 60
QTcF QTcB QTcF QTcB QTcF QTcB
Baseline   
 N 234 237 143 143 60 60
 Missing 60 57 0 0 0 0
 Mean (SD) 387.8 (29.6) 410.8 (32.3) 385.3 (28.6) 408.5 (29.8 386.8 (32.8) 407.7 (33.4)
 Range 290; 478 290; 557 299; 470 309; 486 299; 470 309; 480
Final treatment day   
 N 186 186 143 143   
 Missing 108 108 0 0   
 Mean (SD) 405.9 (28.8) 413.9 (31.8) 404.2 (29.1) 411.8 (32.3)   
 Range 299; 494 289; 500 299; 494 289; 500   
Strict final treatment day   
 N 71 71 60 60 60 60
 Missing 223 223 83 83 0 0
 Mean (SD) 406.7 (36.2) 411.7 (38.8) 404.3 (35.3) 410.2 (38.4) 404.3 (35.3) 410.2 (38.4)
 Range 299; 494 289; 500 299; 494 289; 500 299; 494 289; 500
Absolute change from baseline to final treatment day   
 N 143 146 143 143   
 Missing 151 148 0 0   
 Mean (SD) 18.9 (24.7) 4.0 (26.7) 18.9 (24.7) 3.3 (25.0)   
 Range − 47; 81 − 68; 116 − 47; 81 − 68; 80   
Absolute change from baseline to strict final treatment day   
 N 60 62 60 60 60 60
 Missing 234 232 83 83 0 0
 Mean (SD) 17.5 (18.9) 4.7 (26.7) 17.5 (18.9) 2.6 (22.8) 17.5 (18.9) 2.6 (22.8)
 Range − 23; 69 − 46; 116 − 23; 69 − 46; 80 − 23; 69 − 46; 80
Change in QTcF/QTcB in classes from baseline to final treatment day   
 Missing 151 148 0 0   
 Strict decrease or no change 28 (19.6%) 65 (44.5%) 28 (19.6%) 64 (44.8%)   
 Increase < 30 ms 70 (49.0%) 59 (40.4%) 70 (49.0%) 58 (40.6%)   
 Increase between 30 and 60 ms 36 (25.2%) 20 (13.7%) 36 (25.2%) 20 (14.0%)   
 Increase > 60 ms 9 (6.3%) 2 (1.4%) 9 (6.3%) 1 (0.7%)   
Change in QTcF/QTcB in classes from baseline to strict final treatment day   
 Missing 234 232 83 83 0 0
 Strict decrease or no change 10 (16.7%) 30 (48.4%) 10 (16.7%) 30 (50.0%) 10 (16.7%) 30 (50.0%)
 Increase < 30 ms 36 (60.0%) 24 (38.7%) 36 (60.0%) 23 (38.3%) 36 (60.0%) 23 (38.3%)
 Increase between 30 and 60 ms 12 (20.0%) 6 (9.7%) 12 (20.0%) 6 (10.0%) 12 (20.0%) 6 (10.0%)
 Increase > 60 ms 2 (3.3%) 2 (3.2%) 2 (3.3%) 1 (1.7%) 2 (3.3%) 1 (1.7%)
  1. QTcF/B population: patients with corrected QT interval calculated using Fridericia’s formulae/Bazett’s formulae; Strict QTcF/B population: patients with corrected a QT interval calculated at the strict final treatment day