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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