Table 3.

Grade 3/4 treatment-emergent adverse events

Level 1A* (n = 4)
Level 1 (n = 18)
Level 2 (n = 13)
Level 3 (n = 6)
Total (N = 41)
No. patientsNo. patients (%)
Total with grade 3/4 events41712538 (93)
Neutropenia4139329 (71)
ALT increased287219 (46)
Thrombocytopenia365115 (37)
AST increased243110 (24)
Anemia33309 (22)
Leukopenia24118 (20)
Febrile neutropenia42107 (17)
Vomiting05106 (15)
Asthenia13105 (12)
Stomatitis11103 (7)
Fatigue00213 (7)
Nausea01012 (5)
Pleural effusion00202 (5)
  • NOTE: Adverse events reported at any time from first treatment dose to within 30 d of last treatment dose are included. Drug-related means possible, probable, or very likely. Toxicity grade: National Cancer Institute Common Toxicity Criteria version 3.0.

    Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase.

  • * Patients with severe neutropenia in cycle 1 but without prophylactic G-CSF use.