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Table 2 Treatment administration, modified intent-to-treat population (N = 397)

From: Efficacy of artemether-lumefantrine in relation to drug exposure in children with and without severe acute malnutrition: an open comparative intervention study in Mali and Niger

  SAM
N = 131
Non-SAM
N = 266
P
Dose planned, n (%)    <0.0001
<15 kg: 20/120 mg, 1 tablet per intake, 6 tablets, n (%) 131 (100) 252 (94.7)
≥15 kg: 20/120 mg, 2 tablets per intake, 12 tablets, n (%) 0 14 (5.3)
Lumefantrine dose-weight (mg/kg) – mean (SD) 105.7 (18.6) 73.2 (18.1) <0.0001
  < 60 mg/kg (theoric efficacy threshold), n (%) 2 (1.6) 70 (26.5) <0.0001
  > 100 mg/kg (theoric toxicity threshold), n (%) 81 (62.8) 18 (6.8) <0.0001
Early vomiting within 30 minutes after intake 49 (37.4) 55 (20.7) <0.0001
Did not receive the total treatment dosea 3 (2.3) 5 (1.9) 0.784
  1. aSeven children (three SAM and four non-SAM) discontinued the study before completing the 3-day treatment course: repeated vomiting, 2 in SAM and 1 in non-SAM; infection with other malaria species, 1 in SAM and 1 in non-SAM; patient withdrawal, 2 in non-SAM. For one non-SAM child, an error in administration caused him to receive 11 tablets overall instead of 12
  2. SAM severe acute malnutrition