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Table 4 Subjects with adverse events by body system and preferred term

From: Evaluation of two novel tablet formulations of artemether-lumefantrine (Coartem®) for bioequivalence in a randomized, open-label, two-period study

   80/480 mg tablet Four standard tablets Total* 60/360 mg tablet Three standard tablets Total**
Body system Preferred term N = 58 N = 60 N = 60 N = 57 N = 60 N = 60
n (%) n (%) n (%) n (%) n (%) n (%)
Any body system Total 1 (1.7) 3 (5.0) 4 (6.7) 1 (1.8) 4 (6.7) 5 (8.3)
Gastrointestinal disorders Vomiting 0 (0.0) 1 (1.7) 1 (1.7) 0 (0.0) 1 (1.7) 1 (1.7)
General disorders and administrative site conditions Pyrexia 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (1.7) 1 (1.7)
Injury, poisoning and procedural complications Excoriation 0 (0.0) 0 (0.0) 0 (0.0) 1 (1.8) 0 (0.0) 1 (1.7)
Radius fracture 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (1.7) 1 (1.7)
Navicular bone fracture 0 (0.0) 1 (1.7) 1 (1.7) 0 (0.0) 0 (0.0) 0 (0.0)
Investigations Blood creatine phosphokinase increased 0 (0.0) 1 (1.7) 1 (1.7) 0 (0.0) 1 (1.7) 1 (1.7)
Blood lactate dehydrogenase increased 1 (1.7) 1 (1.7) 2 (3.3) 0 (0.0) 0 (0.0) 0 (0.0)
  1. *An overall summary for all subjects treated with 80/480 mg tablet or four standard tablets.
  2. **An overall summary for all subjects treated with 60/360 mg tablet or three standard tablets.
  3. A subject with multiple adverse events within a system organ class is counted only once in the total row.