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Table 5 Incidence of treatment-emergent adverse events in ≥ 5% of study population up to day 28 post-dose (safety analysis set)

From: A randomised, double-blind clinical phase II trial of the efficacy, safety, tolerability and pharmacokinetics of a single dose combination treatment with artefenomel and piperaquine in adults and children with uncomplicated Plasmodium falciparum malaria

  Artefenomel mg: PQP mg
System Organ Class Preferred term 800:640 (N = 143) 800:960 (N = 148) 800:1440 (N = 146) Total (N = 437)
At least 1 TEAE (n (%) E) 115 (80.4) 266 127 (85.8) 324 122 (83.6) 308 364 (83.3) 898
Infections and infestations (n (%) E) 74 (51.7) 102 76 (51.4) 106 63 (43.2) 82 213 (48.7) 290
 Malaria 43 (30.1) 44 45 (30.4) 48 34 (23.3) 34 122 (27.9) 126
 Bronchitis 13 (9.1) 16 13 (8.8) 19 10 (6.8) 11 36 (8.2) 46
 Rhinitis 11 (7.7) 11 9 (6.1) 10 10 (6.8) 10 30 (6.9) 31
Plasmodium falciparum infection 9 (6.3) 9 10 (6.8) 10 7 (4.8) 7 26 (5.9) 26
Investigations (n (%) E) 58 (40.6) 75 68 (45.9) 100 70 (47.9) 95 196 (44.9) 270
 Electrocardiogram QT prolonged 27 (18.9) 29 41 (27.7) 48 44 (30.1) 56 112 (25.6) 133
 Neutrophil count decreased 18 (12.6) 18 11 (7.4) 11 12 (8.2) 13 41 (9.4) 42
 Haemoglobin decreased 9 (6.3) 9 20 (13.5) 22 11 (7.5) 11 40 (9.2) 42
Gastrointestinal disorders (n (%) E) 31 (21.7) 39 47 (31.8) 60 44 (30.1) 54 122 (27.9) 153
 Diarrhoea 11 (7.7) 12 21 (14.2) 21 20 (13.7) 20 52 (11.9) 53
 Vomiting 14 (9.8) 14 20 (13.5) 20 16 (11.0) 16 50 (11.4) 50
 Abdominal pain 5 (3.5) 5 8 (5.4) 9 12 (8.2) 13 25 (5.7) 27
General disorders and administration site conditions (n (%) E) 11 (7.7) 11 14 (9.5) 16 17 (11.6) 21 42 (9.6) 48
Pyrexia 5 (3.5) 5 12 (8.1) 13 9 (6.2) 11 26 (5.9) 29
  1. N number of subjects affected (%), E number of events