TABLE 4.
Adverse event | No. (%) of subjects by AE severity and treatment group |
|||||
---|---|---|---|---|---|---|
Mild |
Moderate |
Total |
||||
Tafenoquine | Mefloquine | Tafenoquine | Mefloquine | Tafenoquine | Mefloquine | |
Vertigo | 22 (5) | 7 (4) | 0 | 1 (<1) | 22 (5) | 8 (5) |
Somnolence | 12 (2) | 6 (4) | 0 | 0 | 12 (2) | 6 (4) |
Abnormal dreams | 7 (1) | 2 (1) | 0 | 0 | 7 (1) | 2 (1) |
Dizziness | 5 (1) | 2 (1) | 0 | 0 | 5 (1) | 2 (1) |
Insomnia | 4 (<1) | 3 (2) | 1 (<1) | 0 | 5 (1) | 3 (2) |
Abnormal coordination | 2 (<1) | 1 (<1) | 0 | 0 | 2 (<1) | 1 (<1) |
Anxiety | 2 (<1) | 0 | 0 | 0 | 2 (<1) | 0 |
Agitation | 2 (<1) | 0 | 0 | 0 | 2 (<1) | 0 |
Euphoria | 2 (<1) | 0 | 0 | 0 | 2 (<1) | 0 |
Tremor | 2 (<1) | 0 | 0 | 0 | 2 (<1) | 0 |
Depression | 0 | 0 | 1 (<1) | 1 (<1) | 1 (<1) | 1 (<1) |
Paroniria | 1 (<1) | 0 | 0 | 0 | 1 (<1) | 0 |
Amnesia | 1 (<1) | 0 | 0 | 0 | 1 (<1) | 0 |
In total, there were 492 tafenoquine subjects and 162 mefloquine subjects. There were no severe adverse events (AEs) of this type.