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Table 6 Day 7 DEAQ and LF blood concentrations by presence or absence of selected AEs, safety population, Study-T

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-T ASAQ AL
(>5 years) N = 496 N = 502
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 421/496 466 (352,606)   447/502 505 (I 380,670)  
Fatigue (pool)
No AE 250/296 466 (352,605) p = 0.925 376/421 504 (381,659) p = 0.549
AE 171/200 466 (352,606)   71/81 519 (374,709)  
Vomiting
No AE 393/461 461 (345,603) p = 0.003 440/494 505 (381,670) p = 0.711
AE 28/35 559 (467, 705)   7/8 463 (277, 828)  
Nausea
No AE 407/480 466 (352, 605) p = 0.754 443/497 505 (381, 670) p = 0.111
AE 14/16 457 (387, 648)   4/5 245 (100, 549)  
Anaemia
No AE 350/422 462 (352, 604) p = 0.162 403/453 505 (381, 701) p = 0.745
AE 71/74 517 (345, 677)   44/49 508 (374, 616)  
Hepatotoxicity
No AE 402/473 465 (352, 606) p = 0.512 418/471 506 (378, 681) p = 0.882
AE 19/23 485 (407, 586)   29/31 477 (416, 659)  
  1. * 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.