Table 3.

Number of patients with DLT within the first course of BIBF 1120 treatment

Total daily dose (mg)Once dailyTwice daily
All patientsPatients with DLTAll patientsPatients with DLT
5020
10010
15060
150 + 20060
20081 (12.5) AST+γGT increased61 (16.7) CD4 lymphocytes decreased
25061 (16.7) CD4 lymphocytes decreased131 (7.7) nausea
30052 (40) AST+γGT (1), ALT+AST (1)54 (80) nausea+vomiting (1), ALT+AST increased (1), ALT+AST+γGT (1), CD4 lymphocytes decreased + γGT, increased (1)
45032 (66.7) ALT+AST+γGT (1), ALT+γGT (1)

NOTE: DLT was defined as any CTC grade 3 or 4 hematologic or nonhematologic toxicity.