Table 5.
Summary of adverse events among children in the per-protocol population (PP) from southwest Nigeria with acute uncomplicated malaria treated with artemether–lumefantrine or pyronaridine–artesunate
| Event | All patients | Artemether–lumefantrine | Pyronaridine–artesunate | p |
|---|---|---|---|---|
| N = 172 | N = 87 | N = 85 | ||
| Adverse event from any cause | 53 (30.8) | 27 (31.0) | 26 (30.6) | 0.949 |
| Fever | 58 (34.1) | 24 (27.9) | 34 (40.5) | 0.106 |
| Chills and rigors | 33 (19.6) | 16 (18.6) | 17 (20.5) | 0.847 |
| Anorexia | 29 (17.1) | 16 (18.6) | 13 (15.5) | 0.685 |
| Cough | 28 (16.6) | 14 (16.3) | 14 (16.9) | 1.000 |
| Headache | 27 (16.0) | 12 (14.1) | 15 (17.9) | 0.536 |
| Fatigue | 22 (12.9) | 11 (12.6) | 11 (13.1) | 1.000 |
| Pallor | 17 (10.1) | 9 (10.6) | 8 (9.6) | 1.000 |
| Abdominal pains | 12 (7.1) | 5 (5.8) | 7 (8.3) | 0.563 |
| Vomiting | 11 (6.4) | 6 (7.0) | 5 (5.9) | 1.000 |
| Diarrhea | 11 (6.4) | 4 (4.6) | 5 (6.0) | 0.744 |
| Palpitations | 6 (3.5) | 3 (3.4) | 3 (3.6) | 1.000 |
| Nausea | 6 (3.5) | 3 (3.5) | 3 (3.6) | 1.000 |
| Rashes | 1 (0.6) | 0 (0.00) | 1 (1.2) | 1.000 |
AL artemether–lumefantrine, PA pyronaridine–artesunate
*Chi square was used but with Yate correction where cell counts were less than 5