Table 3.
Adverse events (AEs)
| Toxicity code | Dose Level 0: 100 mg | Dose Level 1: 200 mg | Dose Level 2: 400 mg |
|---|---|---|---|
| Total patients experiencing any G3-4 AE | 0/3 | 1/3 | 3/13 |
| Diarrhea | 0 | 0 | 1 |
| Hypertension | 0 | 0 | 1 |
| Hypokalemia | 0 | 1 | 0 |
| Insomnia | 0 | 0 | 1 |
| Nausea | 0 | 0 | 1 |
| Thromboembolic event | 0 | 0 | 2 |
| Urinary incontinence | 0 | 0 | 1 |
| Total patients experiencing any G1-2 AE | 3/3 | 3/3 | 11/13 |
| Anorexia | 0 | 0 | 4 |
| Ataxia | 0 | 0 | 2 |
| Constipation | 0 | 0 | 3 |
| Cough | 0 | 0 | 4 |
| Dehydration | 0 | 0 | 2 |
| Dermatitis radiation | 1 | 0 | 2 |
| Diarrhea | 0 | 0 | 4 |
| Dizziness | 1 | 1 | 6 |
| Dysarthria | 0 | 0 | 2 |
| Edema limbs | 0 | 0 | 2 |
| Fatigue | 1 | 1 | 4 |
| Gait disturbance | 1 | 0 | 2 |
| Headache | 2 | 2 | 2 |
| Hoarseness | 0 | 0 | 2 |
| Hypertension | 1 | 2 | 1 |
| Insomnia | 0 | 0 | 2 |
| Memory impairment | 0 | 0 | 3 |
| Muscle weakness | 0 | 0 | 3 |
| Nausea | 0 | 1 | 5 |
| Nervous system disorders—Other | 0 | 1 | 2 |
| Vomiting | 0 | 1 | 3 |