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Table 5 Adverse events by preferred term and system organ class – safety population (N = 399)

From: Efficacy of artemether-lumefantrine in relation to drug exposure in children with and without severe acute malnutrition: an open comparative intervention study in Mali and Niger

System organ class Preferred term SAM
(N = 133), n (%)
Non-SAM
(N = 266), n (%)
Adverse events reported with frequency > 5 %
 Blood and lymphatic system disorders   6 (4.5) 19 (7.1)
  Anemia 6 (4.5) 19 (7.1)
 Eye disorders   4 (3) 15 (5.6)
  Conjunctivitis 4 (3) 15 (5.6)
 Gastrointestinal disordersa   53 (39.8)a 77 (28.9)a
  Abdominal distensiona 10 (7.5)a 5 (1.9)a
  Diarrheaa 24 (18.0)a 46 (17.3)a
  Gastroenteritisa 15 (11.3)a 10 (3.8)a
  Vomiting 6 (4.5) 7 (2.6)
 Respiratory, thoracic and mediastinal disorders   71 (53.4) 141 (53)
  Bronchitis 38 (28.6) 83 (31.2)
  Cough 11 (8.3) 16 (6)
  Nasopharyngitis 7 (5.3) 15 (5.6)
  Rhinorrhea 15 (11.3) 29 (10.9)
Serious adverse events
 Blood and lymphatic system disorders   1 (0.8) 1 (0.4)
  Anemia 1 (0.8) 1 (0.4)
 Gastrointestinal disorders   0 (0) 1 (0.4)
  Gastrointestinal motility disorder 0 (0) 1 (0.4)
 Nervous system disorders   1 (0.8) 0 (0)
  Meningitis bacterialb 1 (0.8) 0 (0)
 Respiratory, thoracic and mediastinal disorders   1 (0.8) 0 (0)
  Lower respiratory tract infection 1 (0.8) 0 (0)
 Infections and infestations   1 (0.8) 1 (0.4)
  Plasmodium falciparum infectionc 1 (0.8) 1 (0.4)
Adverse events causing treatment discontinuation   2 (1.5) 1 (0.4)
 Gastrointestinal disorders   2 (1.5) 1 (0.4)
  Vomitingd 2 (1.5) 1 (0.4)
  1. Adverse events are reported in alphabetical order of system organ class, then preferred term, according to the MedDRA dictionary (Medical Dictionary for Regulatory Activities, version 11)
  2. aStatistically significant difference between SAM and non-SAM (more gastro-intestinal disorders in SAM)
  3. bCaused death
  4. cSevere malaria in an HIV-coinfected patient
  5. dIn all cases, children vomited less than 30 minutes after drug intake and had iterative vomiting on re-administration
  6. SAM severe acute malnutrition