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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).
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Malaria Journal

ISSN: 1475-2875

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