Table 4 Summary of treatment-emergent adverse events reported in ≥ 5% of patients in any treatment arm (Safety Set)
Preferred term | Artefenomel mg: Ferroquine mg | ||||
|---|---|---|---|---|---|
| Â | 800:400 | 800:600 | 800:900 | 800:1200 | Total |
N | 92 | 94 | 96 | 91 | 373 |
At least 1 TEAE | 84 (91.3) | 87 (92.6) | 85 (88.5) | 81 (89.0) | 337 (90.3) |
Malaria | 55 (59.8) | 50 (53.2) | 41 (42.7) | 41 (45.1) | 187 (50.1) |
Vomiting | 27 (29.3) | 27 (28.7) | 34 (35.4) | 34 (37.4) | 122 (32.7) |
Cough | 10 (10.9) | 7 (7.4) | 15 (15.6) | 15 (16.5) | 47 (12.6) |
Upper Respiratory Tract Infection | 7 (7.6) | 6 (6.4) | 17 (17.7) | 10 (11.0) | 40 (10.7) |
Diarrhoea | 10 (10.9) | 11 (11.7) | 7 (7.3) | 11 (12.1) | 39 (10.5) |
Pyrexia | 7 (7.6) | 2 (2.1) | 9 (9.4) | 10 (11.0) | 28 (7.5) |
Electrocardiogram QT Prolongeda | 6 (6.5) | 5 (5.3) | 6 (6.3) | 8 (8.8) | 25 (6.7) |
Headache | 6 (6.5) | 7 (7.4) | 7 (7.3) | 5 (5.5) | 25 (6.7) |
Abdominal pain | 7 (7.6) | 5 (5.3) | 5 (5.2) | 6 (6.6) | 23 (6.2) |
Decreased Appetite | 5 (5.4) | 8 (8.5) | 5 (5.2) | 5 (5.5) | 23 (6.2) |
Bronchitis | 3 (3.3) | 5 (5.3) | 4 (4.2) | 5 (5.5) | 17 (4.6) |
Rhinitis | 4 (4.3) | 3 (3.2) | 1 (1.0) | 7 (7.7) | 15 (4.0) |