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Table 3 Incidence rate of events reported by system organ classification (grouped by MedDRA® coding) in the total cohort (N = 10,925)

From: Prospective observational study to evaluate the clinical safety of the fixed-dose artemisinin-based combination Eurartesim® (dihydroartemisinin/piperaquine), in public health facilities in Burkina Faso, Mozambique, Ghana, and Tanzania

MedDRA® System organ classification Number of events, (n) Incidence rate per 1,000 (n/N)
Blood and lymphatic system disorders 15 1. 4
Cardiac disorders 5 0. 5
Congenital, familial and genetic disorders 3 0. 3
Ear and labyrinth disorders 2 0. 2
Eye disorders 8 0. 7
Gastrointestinal disorders 150 13. 7
General disorders and administrative site conditions 83 7. 6
Immune system disorders 1 1. 0
Infections and infestations 354 32. 4
Injury, poisoning and procedural complications 5 0. 5
Metabolism and nutrition disorders 14 1. 3
Musculoskeletal and connective tissue disorders 12 1. 1
Nervous system disorders 50 4. 6
Pregnancy, puerperium and perinal conditions 1 0. 1
Psychiatric disorders 4 0. 4
Renal and urinary disorders 2 0. 2
Reproductive system and breast disorders 2 0. 2
Respiratory, thoracic and mediastinal disorders 59 5. 4
Skin and subcutaneous tissue disorders 26 2. 4
Other 1 0. 1