Table 3.
Grade 3 & 4 hematologic and non-hematologic toxicities possibly, probably, or definitely related to study treatment occurring during any treatment course
Hematologic Toxicities | Stratum 1* no. of patients (%) |
Stratum 2* no. of patients (%) |
---|---|---|
Anemia | 0 (%) | 3 (50%) |
Leukopenia | 0 (0%) | 2 (33%) |
Lymphopenia | 0 (0%) | 1 (17%) |
Neutropenia | 4 (27%) | 2 (33%) |
Thrombocytopenia | 1 (7%) | 3 (50%) |
Non-Hematologic Toxicities | Stratum 1* no. of patients (% patients) |
Stratum 2* no. of patients (% patients) |
Cholecystitis | 1 (7%) | 0 (0%) |
Diarrhea | 1 (7%) | 0 (0%) |
Febrile Neutropenia | 0 (0%) | 1 (17%) |
Hypophosphatemia | 1 (7%) | 0 (0%) |
Infection-NOS | 1 (7%) | 0 (0%) |
Infection with normal ANC: upper respiratory-NOS | 0 (0%) | 1 (17%) |
Multi-organ failure (grade 5) | 0 (0%) | 1 (17%) |
Patients with <15% blasts in PB and BM, and no recent myelosuppressive therapy were assigned to stratum 1. Patients with ≥15% blasts in the BM or PB were assigned to stratum 2, as were patients with <15% blasts who had grade 1 or 2 neutropenia or thrombocytopenia from previous myelosuppressive therapy.