Table 3. Drug-related adverse events by maximum grade per patient (N = 30).
| Adverse Event | Grade 1 | Grade 2 | Grade 3 | Grade 4 | Grade 3/4 |
|---|---|---|---|---|---|
| Hematology* | |||||
| Lymphocytopenia | 4 (13%) | 6 (20%) | 11 (37%) | 1 (3%) | 40% |
| White Blood Count | 4 (13%) | 16 (53%) | 6 (20%) | 1 (3%) | 23% |
| Neutropenia | 2 (7%) | 11 (37%) | 3 (10%) | 4 (13%) | 23% |
| Thrombocytopenia | 13 (43%) | 4 (13%) | 4 (13%) | 2 (7%) | 20% |
| Anemia | 6 (20%) | 16 (53%) | 3 (10%) | 1 (3%) | 13% |
| Gastrointestinal disorders | |||||
| Mucositis | 3 (10%) | 1 (3%) | 0 | 0 | 0% |
| Nausea | 13 (43%) | 2 (7%) | 0 | 0 | 0% |
| Vomiting | 5 (17%) | 3 (10%) | 1 (3%) | 0 | 3% |
| Dyspepsia | 8 (27%) | 1 (3%) | 0 | 0 | 0% |
| Gastroesophageal reflux disease | 2 (7%) | 0 | 0 | 0 | 0% |
| Constipation | 6 (20%) | 2 (7%) | 0 | 0 | 0% |
| Diarrhea | 4 (13%) | 0 | 0 | 0 | 0% |
| Chemistry | |||||
| Hyponatremia | 11 (37%) | 0 | 0 | 0 | 0% |
| Hypokalemia | 5 (17%) | 0 | 1 (3%) | 0 | 3% |
| Hypomagnesemia | 11 (37%) | 2 (7%) | 1 (3%) | 0 | 3% |
| Increased AST | 5 (17%) | 2 (7%) | 0 | 0 | 0% |
| Increased ALT | 8 (27%) | 0 | 0 | 0 | 0% |
| Other | |||||
| Fatigue | 7 (23%) | 3 (10%) | 0 | 0 | 0% |
| Skin rash | 3 (10%) | 0 | 0 | 0 | 0% |
| Headache | 7 (23%) | 0 | 0 | 0 | 0% |
| Neuropathy** | 4 (13%) | 0 | 0 | 0 | 0% |
*14 patients (47%) required blood transfusion. 4 patients (13%) received darbepoetin to avoid dose reduction or treatment delay.
**1 of 4 patients had baseline grade 1 neuropathy unchanged with treatment. 3 patients experienced treatment-related recurrence of grade 1 neuropathy.