Table 2.
Frequency, severity, type and drug-relatedness of AE reports per study arm (‘as treated’ analysis)
| PZQ up to week 4 (n = 363) | AM up to week 4 (n = 361) | AM up to week 16 (n = 361) | |
|---|---|---|---|
| Any AEs | 14 (3.9; 2.3 to 6.4)a | 29 (8.0; 5.6 to 11.3)a | 41 (11.4; 8.5 to 15.0) |
| Any drug-related AEs | 8 (2.2; 1.1 to 4.3)a | 28 (7.8; 5.4 to 11.0)a | 36 (10.0; 7.3 to 13.5) |
| Gastrointestinal disorders | 8 (2.2) | 26 (7.2) | 31 (8.6) |
| Abdominal pain | 5 (1.4) | 15 (4.2) | 18 (5.0) |
| Vomiting | 4 (1.1) | 12 (3.3) | 14 (3.9) |
| Diarrhea | 1 (0.3) | 2 (0.6) | 2 (0.6) |
| Odynophagia | – | – | 1 (0.3) |
| Nervous system disorders | – | 4 (1.1) | 7 (1.9) |
| Headache | – | 3 (0.8) | 5 (1.4) |
| Vertigo | – | 1 (0.3) | 2 (0.6) |
| Other disorders | |||
| Skin rash | – | 1 (0.3) | 1 (0.3) |
| Hematuria | – | 1 (0.3) | 1 (0.3) |
| Pyrexia | – | 1 (0.3) | 1 (0.3) |
| Cough | – | – | 1 (0.3) |
| SAEs | – | – | – |
| Death | – | – | – |
| Confirmed malaria cases | – | – | – |
Note 1: AM denotes artesunate–mefloquine; PZQ denotes praziquantel.
Note 2: results are reported as n (%; 95% CI). All AEs (n = 41) reported in the AM arm up to week 16 were classified as mild (n = 5) or moderate (n = 36). No grade 3 (‘severe’) AEs were reported.
aP values, determined with the Fischer’s exact test, were 0.019 and <0.001 for the comparisons between frequency of any AEs and any drug-related AEs, respectively, in the artesunate–mefloquine and praziquantel arms at week 4.