Table 4.
Selected Treatment-Related Acute Adverse Events (n=74)
| CTCAE category | Grade 2 | Grade 3 | Grade 4 | |||
|---|---|---|---|---|---|---|
| CTCAE term | n | % | n | % | n | % |
| Maximum | 15 | 20.3 | 23 | 31.1 | 34 | 45.9 |
|
| ||||||
| Blood/bone marrow | ||||||
|
| ||||||
| Hemoglobin decreased | 12 | 16.2 | 0 | 0.0 | 0 | 0.0 |
| Leukopenia | 2 | 2.7 | 26 | 35.1 | 10 | 13.5 |
| Lymphopenia | 10 | 13.5 | 10 | 13.5 | 2 | 2.7 |
| Neutropenia | 2 | 2.7 | 12 | 16.2 | 30 | 40.5 |
|
| ||||||
| Infection | ||||||
|
| ||||||
| Febrile neutropenia | 0 | 0.0 | 2 | 2.7 | 1 | 1.4 |
| Urinary tract infection [with Grade 3–4 ANC] | 0 | 0.0 | 1 | 1.4 | 0 | 0.0 |
|
| ||||||
| Neurology | ||||||
|
| ||||||
| Peripheral sensory neuropathy | 10 | 13.5 | 1 | 1.4 | 0 | 0.0 |
|
| ||||||
| Constitutional symptoms | ||||||
|
| ||||||
| Fatigue | 42 | 56.8 | 1 | 1.4 | 0 | 0.0 |
|
| ||||||
| Gastrointestinal | ||||||
|
| ||||||
| Constipation | 8 | 10.8 | 1 | 1.4 | 0 | 0.0 |
| Diarrhea | 14 | 18.9 | 2 | 2.7 | 0 | 0.0 |
| Ileus | 0 | 0.0 | 1 | 1.4 | 0 | 0.0 |
| Nausea | 7 | 9.5 | 0 | 0.0 | 0 | 0.0 |
| Vomiting | 4 | 5.4 | 1 | 1.4 | 0 | 0.0 |
|
| ||||||
| Renal/genitourinary | ||||||
|
| ||||||
| Urinary frequency | 15 | 20.3 | 1 | 1.4 | 0 | 0.0 |
| Urinary incontinence | 15 | 20.3 | 0 | 0.0 | 1 | 1.4 |
CTCAE: Common Terminology Criteria for Adverse Events, version 3.0.
ANC: absolute neutrophil count.