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Table 4 Genotype adjusted and non-adjusted day 28 and day 42 cure rates, and day 42 non-inferiority analyses

From: Efficacy of artesunate-amodiaquine and artemether-lumefantrine fixed-dose combinations for the treatment of uncomplicated Plasmodium falciparum malaria among children aged six to 59 months in Nimba County, Liberia: an open-label randomized non-inferiority trial

 

KM cure rate estimates

Observed proportion cured

mITT population

PP population

Day 28

ASAQ

AL

ASAQ

AL

Genotyping-adjusted

% cured [95% CI]

99.3 [95.1–99.9]

97.9 [93.6–99.3]

99.0 [94.6–100]

97.3 [92.3–99.4]

Genotyping-unadjusted

% cured [95% CI]

71.2 [63.1– 77.9]

87.5% [80.9–91.9]

70.2 [61.9–77.6]

87.1 [79.9–92.4]

Day 42

Genotyping-adjusted

% cured [95% CI]

97.3 [91.6–99.1]

94.2 [88.1–97.2]

96.2 [89.2–99.2]

92.2 [83.8–97.1]

% difference # (UL 95% CI*)

−3.1 (1.2)

−3.9 (2.2)

Genotyping-unadjusted

% cured [95% CI]

52.7 [44.3–60.5]

59.5 [50.9–67.1]

53.2 [44.6–61.6]

58. 2 [48.9–67.1]

  1. # Percent difference in day 42 genotyping-adjusted cure rate: AL arm day 42% cured- ASAQ arm day 42% cured. * According to the method of Blackwelder: one-sided 95% upper limit (UL) CI of a two-sided 90% CI around the difference of efficacy of cure rates. The CI was assessed by Wald method.