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Table 1 Patient characteristics at inclusion, safety population (both studies)

From: Tolerability and safety of artesunate-amodiaquine and artemether-lumefantrine fixed dose combinations for the treatment of uncomplicated Plasmodium falciparum malaria: two open-label, randomized trials in Nimba County, Liberia

 

Study-T (> 5 years)

Study-E (6-59 months)

 

ASAQ

AL

ASAQ

AL

N = 496

N = 502

N = 149

N = 150

Demographics and parasite load

Sex (male), N (%)

246 (49.6)

248 (50)

86 (57.7)

89 (59.3)

Mean age (in years, Study-T; in months, Study-E) (SD)

17.3 (12.1)

16.5 (10.6)

37.2 (13.7)

37 (13.6)

Mean weight in kg (SD)

38.3 (15.5)

38.2 (15.5)

12.8 (2.5)

12.9 (2.6)

Geometric mean P. falciparum trophozoite density (/μl), (range)*

624

558

20,020

19,151

(16–355,623)

(16–285,011)

(2,016-415,082)

(2,000-194,127)

P. falciparum and P. malariae mixed infection, N (%)

7 (1.4)

9 (1.8)

-

-

Clinical- and laboratory signs, patients N (%) (any severity grade)

Fever / history of fever in past 48 hrs

491 (99.0)

497 (99.0)

149 (100)

150 (100)

Fatigue

75 (15.1)

76 (15.1)

16 (10.7)

12 (8.0)

Vomiting

48 (9.7)

49 (9.8)

29 (19.5)

21 (14.0)

Diarrhoea

8 (1.6)

11 (2.2)

14 (9.4)

13 (8.7)

Splenomegaly

24 (4.8)

20 (4.0)

21 (14.1)

19 (12.7)

Hepatomegaly

6 (1.2)

7 (1.4)

2 (1.3)

4 (2.7)

Anaemia total

82 (16.5)

80 (15.9)

25 (16.8)

20 (13.3)

Anaemia ≥ grade 3

2 (0.4)

2 (0.4)

10 (6.7)

12 (8.0)

Neutropaenia 1

78 (15.7)

81 (16.1)

21 (14.4)

16 (10.8)

Thrombocytopaenia 2

26 (5.2)

12 (2.4)

6 (4.0)

5 (3.3)

AST increased

38 (8.6)

35 (7.7)

9 (6.1)

10 (6.7)

ALT increased

21 (4.6)

22 (6.2)

3 (2.0)

5 (3.3)

Serum creatinine increased

8 (1.9)

15 (3.6)

1 (0.7)

1 (0.7)

Serum bilirubine (total) increased

12 (2.9)

17 (4.0)

11 (8.0)

13 (9.4)

  1. SD = standard deviation, AST = aspartate aminotransferase, ALT = alanine aminotransferase.
  2. 1Neutropaenia: (cells/μl): <12 years: ≤1,200, ≥12 years: ≤1,500.
  3. 2Thrombocytopaenia: (cells/μl): <12 years: ≤75,000, ≥12 years: ≤99,999.
  4. Anaemia: Hb: (g/dl): <12 years: ≤10.9, ≥12 years: ≤10.5.
  5. AST or ALT increased: <12 years: ≤ 4.9 × ULN, 12 years: ≤2.5 × ULN.
  6. Creatinine increased: <2 years: ≤ 0.8 × ULN, 2- <12 years: ≤1.0, ≥12 years: ≤1.5 × ULN; Bilirubin increased: <12 years or ≥12 years: ≤1.5 × ULN.
  7. Study-T, day 0 measures available:
  8. Hb (Beckman FBC): ASAQ: N = 495, AL: N = 501.
  9. Neutrophil counts: ASAQ: N = 487, AL: N = 496.
  10. Thrombocyte counts: ASAQ: N = 495, AL: N = 501.
  11. AST: ASAQ: N = 441, AL: N = 452.
  12. (Day 0 AST values retrospectively assessed from frozen serum samples: N = 100 ASAQ arm, N = 100 AL arm were included in this table).
  13. ALT: ASAQ: N = 341, AL: N = 352.
  14. Creatinine: ASAQ: N = 412, AL: N = 421 (retrospective from frozen serum).
  15. Bilirubine: ASAQ: N = 413, AL: N = 422 (retrospective from frozen serum).
  16. Study-E, day 0 measures available: Hb (Beckman FBC): ASAQ: N = 146, AL: N = 148, Neutrophil count: ASAQ: N = 139, AL: N = 140.
  17. Thrombocyte count: ASAQ: N = 146, AL: N = 148.
  18. AST: ASAQ: N = 148, AL: N = 150; ALT: ASAQ: N = 148, AL: N = 150.
  19. Creatinine: ASAQ: N = 137, AL: N = 138 (retrospective from frozen serum).
  20. Bilirubine: ASAQ: N = 137, AL: N = 138 (retrospective from frozen serum).