Skip to main content

Table 5 Factors associated with the change in QTcF and QTcB from baseline to the final treatment day or strict final treatment day

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

  QTcF population (N = 143) Strict QTcF population (N = 60) QTcB population (N = 143) Strict QTcB population (N = 60)
n Change in QTcF value from baseline to the final treatment day (ms): mean [CI95%] ANOVA: p-value and R-squared Multivariate analysis (ANOVA, backward selection process) n Change in QTcF value from baseline to the strict final treatment day (ms): mean [CI95%] n Change in QTcF value from baseline to the final treatment day (ms): mean [CI95%] ANOVA: p-value and R-squared Multivariate analysis (ANOVA, backward selection process) n Change in QTcF value from baseline to the strict final treatment day (ms): mean [CI95%]
Total 143 18.9 [14.8; 23.0]    60 17.5 [12.6; 22.4] 143 3.3 [− 0.8; 7.4]    60 2.6 [− 3.3; 8.5]
Sex
 Male 98 18.7 [14.1; 23.4] p = 0.90   42 17.4 [10.9; 23.8] 98 3.9 [− 1.0; 8.8] p = 0.67   42 2.9 [− 4.4; 10.3]
 Female 45 19.3 [10.9; 27.6] R2 = 0.0%   18 17.7 [10.4; 25.0] 45 2.0 [− 6.0; 10.0] R2 = 0.1%   18 1.7 [− 9.0; 12.5]
Age category
 < 18 years old 6 26.5 [1.0; 52.0] p = 0.44   3 14.0 [_34.0; 62.0] 6 − 0.5 [− 19.6; 18.6] p = 0.71   3 − 13.0 [− 35.0; 9.1]
 ≥ 18 years old 137 18.6 [14.4; 22.8] R2 = 0.4%   57 17.6 [12.6; 22.7] 137 3.5 [− 0.8; 7.7] R2 = 0.1%   57 3.4 [− 2.7; 9.5]
 ≤ 65 years old 139 18.4 [14.3; 22.6] p = 0.19 Not retained 58 17.0 [12.0; 22.0] 139 2.5 [− 1.6; 6.7] p = 0.03 Not retained 58 1.6 [− 4.3; 7.4]
 > 65 years old 4 35.0 [20.9; 49.1] R2 = 1.2% 2 31.0 [− 57.9; 119.9] 4 30.5 [4.4; 56.6] R2 = 3.4% 2 32.0 [− 120.5; 184.5]
Ethnicity
 African 118 18.3 [13.7; 23.0] p = 0.54   51 17.2 [11.6; 22.7] 118 2.3 [− 2.5; 7.0] p = 0.29   51 1.6 [− 5.1; 8.3]
 Others 25 21.6 [13.1; 30.2] R2 = 0.3%   9 19.2 [7.9; 30.5] 25 8.1 [0.2; 16.0] R2 = 0.8%   9 8.1 [− 4.2; 20.4]
Smoking status
 Never smoked 101 17.1 [12.3; 21.9] p = 0.18 Not retained 40 15.0 [10.3; 19.7] 101 0.2 [− 4.7; 5.1] p = 0.02 p = 0.0204 40 − 0.0 [− 6.2; 6.2]
 Previous, current smoker or missing information 42 23.2 [15.3; 31.1] R2 = 1.3% 17 22.4 [10.6; 34.2] 42 10.8 [3.4; 18.2] R2 = 3.8% R2 = 3.8% 20 7.8 [− 5.5; 20.9]
Alcohol consumption
 Never/on special occasions 115 19.3 [14.6; 23.9] p = 0.74   45 19.3 [14.1; 24.6] 115 3.2 [− 1.4; 7.8] p = 0.92   45 3.7 [− 2.7; 10.0]
 Ex- or current consumer or missing information 28 17.5 [8.3; 26.7] R2 = 0.1%   15 11.9 [− 0.7; 24.5] 28 3.8 [− 6.3; 13.8] R2 = 0.0%   15 − 0.8 [− 16.1; 14.5]
APQ administered at least 3 h from any meal
 Yes 95 19.1 [14.2; 24.1] p = 0.87   41 20.8 [14.3; 27.2] 95 1.9 [− 3.3; 7.1] p = 0.35   41 5.3 [− 2.3; 13.0]
 No or missing information 48 18.4 [10.9; 26.0] R2 = 0.0%   19 10.4 [3.9; 16.8] 48 6.0 [− 0.9; 13.0] R2 = 0.6%   19 − 3.4 [− 12.5; 5.6]
Patient having taken other treatments known to prolong QTc
 Yes 33 20.6 [12.0; 29.3] p = 0.65   13 17.7 [8.0; 27.3] 33 7.3 [− 0.8; 15.4] p = 0.30   13 8.7 [− 4.4; 21.8]
 No 110 18.4 [13.7; 23.1] R2 = 0.1%   47 17.4 [11.6; 23.2] 110 2.1 [− 2.7; 6.9] R2 = 0.8%   47 0.9 [− 5.9; 7.6]
Liver abnormalities at baseline
 Yes 25 15.9 [5.9; 25.9] p = 0.51   12 11.8 [− 3.0; 26.6] 25 1.9 [− 6.9; 10.6] p = 0.76   12 2.3 [− 13.1; 17.8]
 No or missing information 118 19.5 [15.0; 24.1] R2 = 0.3%   48 18.9 [13.7; 24.0] 118 3.6 [− 1.1; 8.3] R2 = 0.1%   48 2.6 [− 4.0; 9.2]
Renal abnormalities at baseline
 Yes 3 27.7 [2.8; 52.5]    2 32.5 [27.0; 38.0] 3 23.7 [− 27.3; 74.6]    2 34.0 [− 93.1; 161.1]
 No or missing information 140 18.7 [14.6; 22.9]    58 16.9 [11.9; 22.0] 140 2.9 [− 1.3; 7.0]    58 1.5 [− 4.4; 7.4]
  1. QTcF/B: corrected QT interval with Fridericia’s or Bazett’s formulae, QTcF/B population: patients with corrected QT interval calculated using Fridericia’s formulae/Bazett’s formulae, ms: millisecond, CI95%: 95% confidence interval, R2: R-squared, APQ: artenimol-piperaquine; Strict QTcF/B population: patients with corrected a QT interval calculated at the strict final treatment day