Figure 1.
Trial profile of the study and patient flow for a) adults and b) children.
ITT = intent to treat population; PP = per-protocol population.
Table 1.
Baseline demographic and clinical characteristics of the Day 3 per-protocol population.
Figure 2.
Primary efficacy outcome: mean time to PC90 (±95% confidence intervals) in the Day 3 per-protocol population for (a) adults and (b) children.
*P ≤0.05 versus CPG−DDS alone; **P ≤0.01 versus CPG–DDS alone.
Table 2.
Mean time to PC90 (primary endpoint) for the Day 3 per-protocol (PP) population (principal analysis population) and supportive analyses: sensitivity analysis on the Day 3 PP population and outcomes for the Day 14 PP population and the intent to treat (ITT) population.
Table 3.
Ex-vivo parasite viability at 12 h after the first dose of study drug in the Day 3 per-protocol population.
Figure 3.
Results for Day 3 per-protocol population for mean time to PC50 and mean time to PC99 for (a) adults and (b) children.
*P ≤0.05 versus CPG−DDS alone; **P ≤0.01 versus CPG–DDS alone. Five adults (two in the CPG−DDS group, two in the +artesunate 1 mg/kg group and one in the +artesunate 2 mg/kg group) and 14 children (three from the CPG−DDS group, and five, three and three from the +artesunate 1, 2 and 4 mg/kg groups, respectively) were excluded from the mean time to PC50 analysis due to poor model fit. Seven adults (five in the CPG−DDS group, and one each in the +artesunate 1 mg/kg and 2 mg/kg groups) and five children (two from the CPG−DDS group, two from the +artesunate 1 mg/kg and one from the +artesunate 2 mg/kg group) were excluded from the mean time to PC99 analysis due to poor model fit.
Figure 4.
Adults: Percentage of patients who were gametocytemic in the Day 3 per-protocol population at each scheduled assessment time.
Figure 5.
Children: Percentage of patients who were gametocytemic in the Day 3 per-protocol population at each scheduled assessment time.
Table 4.
Treatment responses at Day 14 based on WHO 2002 definitions [20] (Day 14 per-protocol population).
Table 5.
Treatment emergent investigational drug-related adverse events reported during the study and the most common adverse events reported in ≥10% of patients in any treatment group for the intent to treat (safety) population.
Table 6.
Blood parameters where significant changes were observed during treatment for the intent to treat (safety) population.
Table 7.
Number of patients with a decrease in hemoglobin of ≥2 and ≥4 g/dL from baseline for adults and children in the intent to treat (safety) population.