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Table 7 Adverse events

From: Efficacy and safety of fixed dose combination of arterolane maleate and piperaquine phosphate dispersible tablets in paediatric patients with acute uncomplicated Plasmodium falciparum malaria: a phase II, multicentric, open-label study

  Age group 1 (6 months to <2 years) Age group 2 (2 to <6 years) Age group 3 (6 to ≤ 12years) Total (n = 141)
No. of patients with at least one adverse event 22 (100 %) 49 (100 %) 68 (97.1 %) 139 (98.6 %)
Clinical adverse events
 Vomiting 9 (40.9 %) 21 (42.9 %) 5 (7.1 %) 35 (24.8 %)
 Anaemia 1 (4.5 %) 7 (14.3 %) 13 (18.6 %) 21 (14.9 %)
 Cough 2 (9.1 %) 4 (8.2 %) 2 (2.9 %) 8 (5.7 %)
 Pyrexia 0 (0.0 %) 2 (4.1 %) 2 (2.9 %) 4 (2.8 %)
 Diarrhoea 1 (4.5 %) 1 (2.0 %) 0 (0.0 %) 2 (1.4 %)
 Otitis media 1 (4.5 %) 0 (0.0 %) 1 (1.4 %) 2 (1.4 %)
 Headache 0 (0.0 %) 0 (0.0 %) 2 (2.9 %) 2 (1.4 %)
 Hyperhidrosis 0 (0.0 %) 2 (4.1 %) 0 (0.0 %) 2 (1.4 %)
 Abdominal pain 0 (0.0 %) 1 (2.0 %) 0 (0.0 %) 1 (0.7 %)
 Nausea 0 (0.0 %) 1 (2.0 %) 0 (0.0 %) 1 (0.7 %)
 Asthenia 0 (0.0 %) 1 (2.0 %) 0 (0.0 %) 1 (0.7 %)
 Rhinitis 0 (0.0 %) 1 (2.0 %) 0 (0.0 %) 1 (0.7 %)
 Varicella 0 (0.0 %) 1 (2.0 %) 0 (0.0 %) 1 (0.7 %)
 Productive cough 1 (4.5 %) 0 (0.0 %) 0 (0.0 %) 1 (0.7 %)
 Decreased appetite 0 (0.0 %) 1 (2.0 %) 0 (0.0 %) 1 (0.7 %)