Table 1.
Category | Neurological | Hearing | Visual | Gastrointestinal | Chills | |||||
---|---|---|---|---|---|---|---|---|---|---|
| ||||||||||
Dose (mg/kg) | Headache | Feeling abnormal | Fatigue | Dizziness | Hypoacusis | Tinnitus | Blurred vision | Nausea | Vomiting | Chills |
15 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
30 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
60 | 1 | 0 | 0 | 0 | 1 | 2 | 0 | 1 | 1 | 0 |
90 | 2 | 1 | 1 | 0 | 3 | 0 | 1 | 1 | 0 | 2 |
120 | 3 | 1 | 2 | 2 | 3 | 4 | 2 | 2 | 1 | 2 |
130 | 3 | 2 | 4 | 1 | 4 | 4 | 1 | 3 | 1 | 6 |
140 | 5 | 0 | 2 | 3 | 6 | 4 | 2 | 2 | 1 | 7 |
150 | 2 | 0 | 0 | 2 | 2 | 1 | 0 | 1 | 1 | 1 |
| ||||||||||
Total | 16 | 4 | 9 | 8 | 19 | 15 | 6 | 10 | 5 | 18 |
Data are presented as number of self-reported adverse events (AE) in each dose category. Many subjects reported more than one AE