Table 2.
Treatment administration, modified intent-to-treat population (N = 397)
| 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 |
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
SAM severe acute malnutrition