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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