Table V.
Toxicity
| Toxicity | Grade 1(%) | Grade 2 (%) | Grade 3 (%) | Grade 4 (%) |
|---|---|---|---|---|
| Alopecia | 4 (6) | 48 (77) | 0 | 0 |
| Allergic Reaction | 2 (3) | 1 (1) | 0 | 0 |
| Anorexia | 27 (44) | 11 (17) | 0 | 0 |
| Arthralgia/myalgia | 19 (31) | 12 (19) | 0 | 0 |
| Bone pain | 29 (47) | 12 (19) | 0 | 0 |
| Constipation | 14 (23) | 5 (8) | 1 (1) | 0 |
| Dehydration/IV fluids | 5 (8) | 1 (1) | 0 | 0 |
| Depression | 10 (16) | 8 (13) | 0 | 0 |
| Diarrhea | 18 (29) | 15 (24) | 8 (13) | 0 |
| Dizziness | 30 (48) | 2 (3) | 0 | 0 |
| Fatigue | 19 (31) | 23 (37) | 8 (13) | 0 |
| Fever | 11 (17) | 12 (19) | 2 (3) | 0 |
| Edema | 15 (24) | 3 (5) | 0 | 0 |
| Headache | 15 (24) | 2 (3) | 0 | 0 |
| Hypotension | 1 (1) | 3 (5) | 0 | 0 |
| Hematologic | ||||
| Neutropenia | 1 (1) | 2 (3) | 17 (27)* | 5 (8)* |
| Neutropenic fever | 0 | 0 | 17 (27) | 5 (8) |
| Thrombocytopenia | 12 (26) | 18 (39) | 16 (35) | 0 |
| Laboratory | ||||
| Abnormalities** | 0 | 26 (46) | 20 (43) | 0 |
| Anemia | 33 (72) | 3 (6) | 6 (13) | 0 |
| Hypomagnesemia | 0 | 1 (2) | 0 | 0 |
| Elevated creatinine | 21 (46) | 5 (11) | 2 (4) | 2 (4) |
| Transaminitis | 0 | 2 (4) | 0 | 1 (2)*** |
| Hyperbilirubinemia | ||||
| Mucositis | 17 (27) | 5 (8) | 0 | 0 |
| Nausea | 26 (42) | 17 (27) | 3 (5) | 1 (1) |
| Neuropathy | 23 (37) | 19 (31) | 12 (19) | 0 |
| Rash | 7 (11) | 1 (1) | 0 | 0 |
| Tinnitus | 2 (3) | 3 (5) | 0 | 0 |
| Vomiting | 24 (39) | 11 (17) | 5 (8) | 1 (1) |
| Weight Loss | 3 (5) | 2 (3) | 1 (1) | 0 |
*
does not include patients with neutropenic fever
**
NCI cohort, n=46
***
Gilbert’s syndrome