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Table 5 Adverse events (AEs) occurring during the whole study period

From: Repeated treatment of recurrent uncomplicated Plasmodium falciparum malaria in Senegal with fixed-dose artesunate plus amodiaquine versus fixed-dose artemether plus lumefantrine: a randomized, open-label trial

  ASAQ
(n = 184)
AL
(n = 182)
Emergent AEs 60 60
Treatment-related AEs (%)a 32 (53.3) 21 (35.0)
AE of special interestb (%) 4 (6.7)c 4 (6.7)c
Pregnancy (%) 0 1 (1.7)c
Serious AEs (%) 1 (1.7) 1 (1.7)
Deaths 0 0
AE intensity (%)   
   Mild 45 (75.0) 44 (73.3)
   Moderate 13 (21.7) 15 (25.0)
   Severe 2 (3.3) 1 (1.7)
Overall study (%)   
   Patients with at least one AE 47 (25.5) 47 (25.8)
   Patients with at least one treatment-related AE 26 (14.1) 17 (9.3)
   Patients with at least one SAE and permanent study withdrawal due to AE 1 (0.5) 1 (0.5)
First episode (%)   
   Patients with at least one AE 43 (23.4) 41 (22.5)
   Patients with at least one SAE and permanent study withdrawal due to AE 1 (0.5) 1 (0.5)
Second episode (%)   
   Patients with at least one AE 4 (14.8) 8 (24.2)
  1. aPercentage of emergent events. bNeutropenia <400 neutrophils/mm3 in children or <750 neutrophils/mm3 in adults. cOccurred during 28 days of first episode evaluation.