Table 4. Treatment-emergent adverse events occurring in more than one patient.
Phase I 20 mg/d (n = 3) | Phase I 30 mg/d (n = 3) | Phase II 3-h infusion (20 mg/d) (n = 7) | Phase II 24-h infusion (60 mg/d) (n = 5) | All (N = 18) | ||||||
n | All grade | Grade ≥3 | All grade | Grade ≥3 | All grade | Grade ≥3 | All grade | Grade ≥3 | All grade | Grade ≥3 |
Euphoria | 3 | 0 | 2 | 0 | 6 | 1 | 1 | 0 | 12 | 1 |
Somnolence | 0 | 0 | 2 | 2 | 4 | 1 | 2 | 0 | 8 | 3 |
Ataxia | 0 | 0 | 3 | 1 | 3 | 0 | 1 | 1 | 7 | 2 |
Dizziness | 1 | 0 | 1 | 0 | 2 | 1 | 1 | 1 | 5 | 2 |
Confusion | 0 | 0 | 2 | 1 | 1 | 0 | 2 | 0 | 5 | 1 |
Constipation | 1 | 0 | 1 | 3 | 5 | |||||
Fever | 0 | 0 | 0 | 0 | 3 | 1 | 2 | 0 | 5 | 1 |
Diarrhea | 1 | 1 | 1 | 1 | 4 | |||||
Peripheral edema | 0 | 0 | 2 | 2 | 4 | |||||
Febrile neutropenia | 0 | 0 | 1 | 1 | 2 | 2 | 1 | 1 | 4 | 4 |
Disorientation | 2 | 0 | 1 | 0 | 3 | |||||
Cough | 0 | 1 | 2 | 0 | 3 | |||||
Unsteady gait | 0 | 1 | 2 | 0 | 3 | |||||
Insomnia | 1 | 0 | 2 | 0 | 3 | |||||
Dyspnea | 0 | 0 | 1 | 2 | 3 | |||||
Hypoxia | 0 | 0 | 0 | 0 | 3 | 1 | 0 | 0 | 3 | 1 |
Dysarthria | 1 | 0 | 2 | 0 | 3 | |||||
Fatigue | 0 | 0 | 0 | 0 | 2 | 0 | 1 | 1 | 3 | 1 |
Headache | 0 | 0 | 2 | 1 | 3 | |||||
Ecchymosis | 0 | 0 | 3 | 0 | 3 | |||||
Hypotension | 0 | 0 | 1 | 1 | 2 | |||||
Tachycardia | 0 | 0 | 2 | 0 | 2 | |||||
Cardiac murmur | 0 | 0 | 2 | 0 | 2 | |||||
Atrial fibrillation | 0 | 0 | 0 | 0 | 2 | 2 | 0 | 0 | 2 | 2 |
Pneumonia | 1 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 2 | 2 |
Loose stool | 1 | 0 | 1 | 0 | 2 | |||||
Gingival pain | 0 | 1 | 1 | 0 | 2 | |||||
Cytokine release syndrome | 1 | 0 | 1 | 0 | 2 | |||||
Abnormal breath sounds | 0 | 0 | 1 | 1 | 2 | |||||
Acute MI | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 1 | 2 | 2 |
Dry mouth | 0 | 0 | 1 | 1 | 2 | |||||
Crackles (lung) | 0 | 0 | 1 | 1 | 2 | |||||
Thrush | 0 | 0 | 2 | 0 | 2 | |||||
Hypocalcemia | 0 | 1 | 1 | 0 | 2 | |||||
Hypokalemia | 0 | 1 | 1 | 0 | 2 | |||||
Slurred speech | 0 | 0 | 2 | 0 | 2 | |||||
Agitation | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 2 | 1 |
Muscular weakness | 0 | 0 | 1 | 1 | 2 | |||||
Anxiety | 0 | 1 | 1 | 0 | 2 |