Table 2.
Adverse Events (≥ grade 3; possibly, probably or definitely attributed to therapy)
| Grade | |||||||
|---|---|---|---|---|---|---|---|
| 3 | 4 | 5 | |||||
| Adverse Event* | Arm | No. of Patients |
% | No. of Patients |
% | No. of Patients |
% |
| Hematologic adverse events | |||||||
| Hemoglobin | A | 6 | 15 | 1 | 2 | 0 | — |
| B | 1 | 7 | 0 | - | 0 | — | |
| Leukocytes (total WBC) | A | 14 | 34 | 6 | 15 | 0 | — |
| B | 3 | 20 | 2 | 13 | 0 | — | |
| Lymphopenia | A | 2 | 5 | 0 | — | 0 | — |
| B | 2 | 13 | 0 | — | 0 | — | |
| Neutrophils/granulocytes (ANC/AGC) | A | 12 | 29 | 21 | 51 | 0 | — |
| B | 3 | 20 | 6 | 40 | 0 | — | |
| Platelets | A | 9 | 22 | 5 | 12 | 0 | — |
| B | 3 | 20 | 0 | — | 0 | — | |
| Transfusion: platelets | A | 3 | 7 | 0 | — | 0 | — |
| B | 1 | 7 | 0 | — | 0 | — | |
| Transfusion: RBCs | A | 4 | 10 | 0 | — | 0 | — |
| B | 1 | 7 | 0 | — | 0 | — | |
| Maximum hematologic adverse events | A | 13 | 32 | 23 | 56 | 0 | — |
| B | 3 | 20 | 6 | 40 | 0 | — | |
| Nonhematologic adverse event | |||||||
| Fatigue (asthenia, lethargy, malaise) | A | 6 | 15 | 1 | 2 | 0 | — |
| B | 1 | 7 | 0 | — | 0 | — | |
| Dehydration | A | 4 | 10 | 0 | — | 0 | — |
| B | 0 | — | 0 | — | 0 | — | |
| Nausea | A | 5 | 12 | 0 | — | 0 | — |
| B | 1 | 7 | 0 | — | 0 | — | |
| Vomiting | A | 3 | 7 | 0 | — | 0 | — |
| B | 0 | — | 0 | — | 0 | — | |
| Infection without neutropenia | A | 4 | 10 | 0 | — | 0 | — |
| B | 1 | 7 | 0 | — | 0 | — | |
| Hyperglycemia | A | 3 | 7 | 0 | — | 0 | — |
| B | 0 | — | 0 | — | 0 | — | |
| Hypokalemia | A | 2 | 5 | 1 | 2 | 0 | — |
| B | 0 | — | 0 | — | 0 | — | |
| Hyponatremia | A | 5 | 12 | 1 | 2 | 0 | — |
| B | 2 | 13 | 2 | 13 | 0 | — | |
| Maximum nonhematologic adverse events | A | 18 | 44 | 6 | 15 | 2 | 5 |
| B | 4 | 27 | 3 | 20 | 0 | — | |
| Maximum overall adverse events | A | 12 | 29 | 24 | 59 | 2 | 5 |
| B | 4 | 27 | 7 | 47 | 0 | — | |
Abbreviations: ANC, absolute neutrophil count; AGN, absolute granulocyte count.
*
Toxicities experienced by ≤ two patients on study are not individually listed, but are included in the summaries of maximum adverse events.