Table 5.
Incidence of treatment-emergent adverse events in ≥ 5% of study population up to day 28 post-dose (safety analysis set)
| 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 |
N number of subjects affected (%), E number of events