Number of participants | Body weight |
|---|
All | 5 to < 15 kg | | 15 to < 25 kg | 25 to < 35 kg |
|---|
5 to < 10 | 10 to < 15 | | |
|---|
Randomized population | 547 | 168 | 379 | 289 | 63 |
ITT populationa | 535 | 164 | 371 | 288 | 63 |
mITT populationb | 477 | 143 | 334 | 277 | 58 |
Safety population | 547 | 168 | 379 | 289 | 63 |
- Patients could have more than one reason for exclusion from the ITT and mITT populations.
- a Reasons for exclusion from ITT population: no relevant post-baseline efficacy assessment (n = 12), no full dose of study medication taken (n = 9) and no P. falciparum at baseline (n = 1)
- b Reasons for exclusion from the mITT population were as for the ITT population, and additionally no day 28 parasite count without being a failure prior to day 28 (n = 68), vomiting of replacement dose or two replacements and subsequent vomiting (n = 16), reappearance of parasite but no valid PCR analysis until day 28 (n = 7), switch to rescue for other reasons (n = 4) and use of concomitant anti-malarials other than rescue medication (n = 4)
