TABLE 5.
Table of adverse events attributed as related to study drug during prophylactic phase in the safety populationa
| Adverse event | No. (%) of patients in treatment group |
|
|---|---|---|
| Tafenoquine (n = 492) | Mefloquine (n = 162) | |
| At least one AE | 66 (13.4) | 19 (11.7) |
| Nausea | 14 (2.8) | 4 (2.5) |
| Vertigo | 10 (2.0) | 2 (1.2) |
| Diarrhea | 9 (1.8) | 3 (1.9) |
| Abdominal pain | 7 (1.4) | 2 (1.2) |
| Abnormal dreaming | 6 (1.2) | 1 (0.6) |
| Somnolence | 6 (1.2) | 1 (0.6) |
| Headache | 3 (0.6) | 2 (1.2) |
| Insomnia | 3 (0.6) | 2 (1.2) |
a
Events occurring in >1% of subjects are shown. AE, adverse event.