Table 4.
Part and schedule | Dose level (mg/m2/dose) | Pt. no. | Description and grade |
---|---|---|---|
A1 (daily) | 45 | 4 | Somnolence, Gr 2 |
5 | Anxiety, Gr 1; depression, Gr 1; somnolence, Gr 2 | ||
6 | Depression, Gr 2 | ||
7 | Agitation, Gr 1 | ||
60 | 13 | Somnolence, Gr 2; memory impairment, Gr 2 | |
80 | 15 | Euphoria, Gr 2 | |
16 | Depression, Gr 4a | ||
17 | Agitation; Gr 2 | ||
19 | Depression, Gr 1 | ||
100 | 20 | Agitation, Gr 1 | |
21 | Somnolence, Gr 2; dizziness, Gr 1 | ||
23 | Agitation, Gr 1 | ||
24 | Dizziness, Gr 1 | ||
A2 (twice daily) | 40 | 27 | Personality/behavioral, Gr 1 |
29 | Somnolence, Gr 2 | ||
31 | Depression, Gr 1; dysphoria, Gr 1 | ||
30 | 32 | Agitation, Gr 1 | |
36 | Personality/behavioral, Gr 1 |
Grade 1 depression at baseline.