Table 5.
Grade 3 or 4 Adverse Events with Relationship (possible or higher) to Sorafenib + Erlotinib
| Adverse Event | DL0 (MTD, N = 25) | DL1 (N = 7) | DL2 (N = 3) | Total (N = 35) |
|---|---|---|---|---|
| Alanine aminotransferase increased | 1 (4%) | 1 (3%) | ||
| Aspartate aminotransferase increased | 1 (4%) | 1 (3%) | ||
| Diarrhea | 1 (4%) | 1 (3%) | ||
| Generalized muscle weakness | 5 (20%) | 5 (14%) | ||
| Fatigue (aethenia, lethargy, malaise) | 1 (4%) | 1 (3%) | ||
| Hypertension | 2 (8%) | 1 (14%) | 3 (9%) | |
| Hypophosphatemia | 3 (12%) | 2 (29%) | 1 (33%) | 6 (17%) |
| Lipase increased | 1 (4%) | 2 (67%) | 3 (9%) | |
| Lymphocyte count decreased | 1 (4%) | 1 (3%) | ||
| Rash (maculo-papular) | 1 (4%) | 1 (3%) |