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Table 7 Day 7 DEAQ and LF blood concentrations by presence or absence of selected AEs, safety population, Study-E

From: Tolerability and safety of artesunate-amodiaquine and artemether-lumefantrine fixed dose combinations for the treatment of uncomplicated Plasmodium falciparum malaria: two open-label, randomized trials in Nimba County, Liberia

Study-E ASAQ AL
(6–59 months) N = 149 N = 150
AEs of interest Patients DEAQ blood concentration p-value Patients LF blood concentration p-value
n/N* [ng/ml] median (IQR) ** n/N* [ng/ml] median (IQR) **
All patients 137/149 423 (314,602)   139/150 310 (200,447)  
Fatigue (pool)
No AE 93/105 396 (302,529) p = 0.004 122/130 332 (200,447) p = 0.332
AE 44/44 501 (354,794)   17/20 256 (100,344)  
Vomiting
No AE 122/133 435 (314,602) p = 0.725 130/140 313 (200,447) p = 0.428
AE 15/16 366 (277,743)   9/10 256 (100,329)  
Nausea
No AE 137/149 423 (314,602) na 138/149 310 (200,447) na
AE 0/0 -   1/1 256  
Anaemia
No AE 105/115 423 (310,554) p = 0.455 116/127 305 (150,431) p = 0.030
AE 32/34 443 (332,739)   23/23 380 (262,566)  
Hepatotoxicity
No AE 125/136 416 (311,554) p = 0.065# 121/132 329 (217,457) p = 0.049
AE 12/13 569 (354,934)   18/18 150 (100,409)  
  1. AE = adverse event; * n/N = number of blood samples available and quantifiable (n) among total patients with or without AE (N); ** Two-sample Wilcoxon rank-sum (Mann–Whitney) test; # When patients with deviations (quantifiable AQ on day 0 or day 7) were excluded from this comparative analysis (n = 6): p = 0.036.