Table 4.
Most common adverse events Grades 1–2
| GTE |
|||||
|---|---|---|---|---|---|
| Adverse Events | Placebo (n=11) |
500 mg/m2 (n=11) |
750 mg/m2 (n=9) |
1 gm/m2 (n=10) |
All doses (n=30) |
| Insomnia | 18.2% | 18.2% | 44.4% | 50% | 36.7% |
| Nausea | 0% | 36.4% | 22.2% | 30% | 30% |
| Nervousness | 9.1% | 9.1% | 11.1% | 60% | 26.7% |
| Headache | 18.2% | 27.3% | 11.1% | 40% | 26.7% |
| Dyspepsia | 18.2% | 9.1% | 11.1% | 20% | 13.3% |
| Flatulence | 9.1% | 9.1% | 11.1% | 20% | 13.3% |
| Diarrhea | 18.2% | 9.1% | 11.1% | 10% | 10% |
| Abdominal pain | 18.2% | 9.1% | 11.1% | 0% | 6.7% |
| Back pain | 9.1% | 9.1% | 0% | 10% | 6.7% |
| Abnormal EKG | 0% | 9.1% | 0% | 10% | 6.7% |
| Gastric Reflux | 0% | 9.1% | 11.1% | 0% | 6.7% |
| Dizziness | 0% | 9.1% | 0% | 10% | 6.7% |
| Rhinitis | 0% | 0% | 22.2% | 0% | 6.7% |
| Sinusitis | 0% | 0% | 11.1% | 10% | 6.7% |
| Eyelid twitching | 0% | 18.2% | 0% | 0% | 6.7% |
| Urinary frequency | 0% | 9.1% | 0% | 10% | 6.7% |
| Constipation | 9.1% | 0% | 11.1% | 0% | 3.3% |
| Paresthesia | 9.1% | 0% | 0% | 10% | 3.3% |