Table 1.

Criteria for DLTs

Qualifying event
Study drug–related AE occurring in the first 28 days of study participation and any of the following:
 >Grade III nausea, vomiting, or diarrhea not controlled by anti-emetic/antidiarrheal therapy
 >Grade II neuropathy with pain
 Grade IV neutropenia (ANC <0.5 × 109/L) lasting >14 days without growth factor support
 Febrile neutropenia (ANC <1.0 × 109/L with fever ≥38.3°C)
 Grade 4 thrombocytopenia (<25.0 × 109/L) lasting >7 d or associated with bleeding
 Other nonhematologic toxicity ≥grade III

Abbreviation: AE, adverse events.