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Table 1 Characteristics of participants—safety registry of malaria patients treated with artenimol-piperaquine

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

  Safety population QTcF population Strict QTcF population
N = 294 N = 143 N = 60
Age (years)
 Mean (SD) 39.8 (13.2) 37.5 (12.4) 37.7 (12.1)
 Range 1.5; 74.0 12.0; 72.0 12.0; 72.0
Age category
 ≤ 12 years old 5 (1.7%) 1 (0.7%) 1 (1.7%)
 13–17 years old 5 (1.7%) 5 (3.5%) 2 (3.3%)
 ≥ 18 years old 284 (96.6%) 137 (95.8%) 57 (95.0%)
Gender
 Male 205 (69.7%) 98 (68.5%) 42 (70.0%)
 Female 89 (30.3%) 45 (31.5%) 18 (30.0%)
Ethnicity
 Missing 1   
 Oriental 1 (0.3%)   
 African 248 (84.6%) 118 (82.5%) 51 (85.0%)
 Caucasian 40 (13.7%) 24 (16.8%) 8 (13.3%)
 Hispanic 1 (0.3%) 1 (0.7%) 1 (1.7%)
 Other 3 (1.0%)   
Body Mass Index at visit 1 (kg/m2)
 Mean (SD) 25.9 (4.7) 25.6 (4.6) 26.1 (5.2)
 Range 15.7; 42.2 17.1; 13.9 18.2; 37.8
Smoking status
 Missing 12 5 3
 Never smoked 205 (72.7%) 101 (73.2%) 40 (70.2%)
 Previous smoker 39 (13.8%) 16 (11.6%) 9 (15.8%)
 Current smoker 38 (13.5%) 21 (15.2%) 8 (14.0%)
Alcohol consumption
 Missing 14 5 3
 Never/on special occasions (less than once a week) 237 (84.6%) 115 (83.3%) 45 (78.9%)
 Ex-consumer 5 (1.8%) 3 (2.2%) 2 (3.5%)
 Current consumer 38 (13.6%) 20 (14.5%) 10 (17.5%)
At least one illness history
 Yes (cf Additional file for details) 124 (42.2%) 55 (38.5%) 26 (43.3%)
 No 170 (57.8%) 88 (61.5%) 34 (56.7%)
Clinical symptoms at enrolment
 Yes 278 (94.6%) 138 (96.5%) 56 (93.3%)
 No 16 (5.4%) 5 (3.5%) 4 (6.7%)
Symptoms
 Fever 261 (88.8%) 128 (89.5%) 50 (83.3%)
 Headache 195 (66.3%) 99 (69.2%) 41 (68.3%)
 Shivering 146 (49.7%) 78 (54.5%) 33 (55.0%)
 Arthralgia 137 (46.6%) 72 (50.3%) 27 (45.0%)
 Sweating 110 (37.4%) 55 (38.5%) 21 (35.0%)
 Vomiting 107 (36.4%) 49 (34.3%) 15 (25.0%)
 Anemia 26 (8.8%) 11 (7.7%) 7 (11.7%)
 Jaundice 14 (4.8%) 6 (4.2%) 4 (6.7%)
 Splenomegaly 14 (4.8%) 8 (5.6%) 1 (1.7%)
 Hepatomegaly 3 (1.0%) 3 (2.1%) 3 (5.0%)
 Retinal damage 0 0 0
 Coma 1 (0.3%) 0 0
 Other symptom 103 (35.0%) 51 (35.7%) 23 (38.3%)
  1. QTcF population: patients with corrected QT interval calculated using Fridericia’s formulae, SD: Standard deviation Strict Strict QTcF/B population: patients with corrected a QT interval calculated at the strict final treatment day