Table 2.
Adverse Events
Adverse Event | Grade 1 | Grade 2 | Grade 3 | Grade 4 |
---|---|---|---|---|
Dose Level 1: PAC-1 375 mg + TMZ 150 mg/m2 | ||||
Hematologic | ||||
Anemia | 3 | 0 | 0 | 0 |
Leukopenia | 1 | 1 | 0 | 0 |
Lymphopenia | 1 | 2 | 0 | 0 |
Non-Hematologic | ||||
Fatigue | 3 | 2 | 0 | 0 |
Fever | 1 | 0 | 0 | 0 |
Confusion | 1 | 0 | 0 | 0 |
Somnolence | 0 | 1 | 0 | 0 |
Neurologic, other | 3 | 0 | 0 | 0 |
Concentration impairment | 1 | 0 | 0 | 0 |
Dysgeusia | 1 | 0 | 0 | 0 |
Bruising | 1 | 0 | 0 | 0 |
Arthralgia | 1 | 0 | 0 | 0 |
ALT increase | 0 | 0 | 1 | 0 |
AST increase | ||||
Dose Level 2: PAC-1 500 mg + TMZ 150 mg/m2 | ||||
Non-Hematologic | ||||
Cognitive disturbance | 0 | 1 | 0 | 0 |
Headache | 0 | 1 | 0 | 0 |
Paresthesia | 0 | 1 | 0 | 0 |
Neurologic, other | 1 | 0 | 0 | 0 |
Dose Level 3: PAC-1 625 mg + TMZ 150 mg/m2 | ||||
Non-Hematologic | ||||
Fatigue | 2 | 0 | 0 | 0 |
Dizziness | 1 | 0 | 0 | 0 |
Headache | 1 | 0 | 0 | 0 |
Constipation | 1 | 0 | 0 | 0 |
Diarrhea | 1 | 0 | 0 | 0 |