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Table 2 Summary of adverse events recorded up to day 28, 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)
Patients N (%) ASAQ AL ASAQ AL
N = 496 N = 502 N = 149 N = 150
AE summary
At least one AE (any grade) 457 (92.1) 453 (90.2) 141 (94.6) 132 (88.0)
At least one AE ≥ grade 3 17 (3.4) 8 (1.6) 6 (4.0) 4 (2.7)
Serious AE (SAE) 1 (0.2) * 0 (0) 2 (1.3) 1 (0.7)
AE leading to treatment discontinuation 0 0 0 1 (0.7)
Common clinical- or laboratory AEs (≥5% in at least one study arm, any severity grade) #
Fatigue ** 200 (39.8) 81 (16.3) 43 (28.9) 20 (13.3)
Headache 52 (10.5) 42 (8.4) 2 (1.3) 2 (1.3)
AE Vomiting (any) 35 (7.1) 8 (1.6) 16 (10.7) 10 (6.7)
AE Vomiting (after drug intake) 2 (0.4) 0 9 (6.0) 4 (2.7)
Abdominal pain 29 (5.8) 18 (3.6) 3 (2.0) 4 (2.7)
Anorexia 29 (5.8) 7 (1.4) 2 (1.3) 2 (1.3)
Cough - - 28 (18.8) 21 (14.0)
Diarrhoea 20 (4.0) 14 (2.8) 14 (9.4) 14 (9.3)
Eosinophilia ≠ 144 (29.0) 185 (36.9) 6 (4.0) 9 (6.0)
Neutropaenia 94 (19.0) 110 (21.9) 6 (4.0) 8 (5.3)
Leukopaenia 37 (7.5) 29 (5.8) 10 (6.7) 3 (2.0)
Leukocytosis 21 (4.2) 44 (8.8) 10 (6.7) 11 (7.3)
Anaemia 74 (14.9) 49 (9.8) 34 (22.8) 23 (15.3)
AST increased 17 (3.4) 21 (4.2) 8 (5.4) 12 (8.0)
ALT increased 11 (2.2) 17 (3.4) 10 (6.7) 12 (8.0)
  1. AE = adverse event, AST = aspartate aminotransferase, ALT = alanine aminotransferase.
  2. # This section provides a summary of the most common AEs recorded (≥5%, any treatment arm), regardless of the severity or relationship to the study drug.
  3. In cursive letters: ≥5% in at least one arm of any of the two parallel studies, respectively.
  4. * SAE spontaneous abortion (ASAQ arm, Study-T).
  5. ** Pooled were reported events of “weakness”, “fatigue” and “asthenia”.
  6. ≠ AE recorded if above normal range (0.2-2.0 < 6 years; 0.3-0.8 × 103/μL ≥ 6 - <12 years, 0.04 -0.4 × 103/μL ≥12 years).