Skip to main content

Table 3 Summary of severe adverse events recorded up to day 28, safety population (both studies)

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 (>5 years) Study-E (6–59 months)
Patients N (%) ASAQ AL ASAQ AL
N = 496 N = 502 N = 149 N = 150
AEs with severity grade ≥ 3
Hepatitis 1 (0.2) 0 - -
Stomatitis - - 0 1 (0.7)
Vomiting # - - 0 1 (0.7)
Malaria # - - 1 (0.7) 0
Pneumonia # - - 1 (0.7) 0
Splenomegaly 7 (1.4) 1 (0.2) - -
Thrombocytopenia 2 (0.4) 0 4 (2.7) 1 (0.7)
Leukocytosis 2 (0.4) 4 (0.8) - -
Neutropaenia 2 (0.4) 1 (0.2) - -
Anaemia 1 (0.2) 0 3 (2.0) 1 (0.7)
AST increased 3 (0.6) 1 (0.2) - -
ALT increased 1 (0.2) 0 - -
Hepatomegaly 0 1 (0.2) - -
  1. AE adverse event, AST aspartate aminotransferase, ALT alanine aminotransferase.
  2. # These severe AEs were also reported as serious AEs (Study-E).