Table 2. Summary of Toxicities in > 10% of Subjects or Any Grade 3 or 4 Toxicities.
Toxicity | Any Grade n, (%) |
Grade 3 or 4 n, (%) |
At Baseline n, (%) |
---|---|---|---|
Constitutional | |||
Fatigue | 10 (50) | 2 (10) | 6 (30) |
Sweating | 4 (20) | 3 (15) | |
Anorexia | 4 (20) | 2 (10) | |
Insomnia | 4 (20) | 1 (5) | |
Dermatologic | |||
Skin disorder | 5 (25) | 2 (10) | |
Skin infection | 1 (5) | 1 (5) | |
Gastroenterology | |||
Constipation | 6 (30) | 2 (10) | |
Nausea | 6 (30) | 1 (5) | |
Diarrhea | 4 (20) | 1 (5) | |
Vomiting | 3 (15) | 1 (5) | |
Hematologic | |||
Low hemoglobin | 16 (80) | 12 (60) | |
Lymphopenia | 9 (45) | 3 (15) | |
Leukopenia | 5 (25) | ||
Low ANC | 2 (10) | 1 (5) | |
Hepatic | |||
High ALT/AST | 6 (30) | 4 (20) | |
High alkaline phosphatase | 5 (25) | 2 (10) | |
Metabolic | |||
High glucose | 10 (50) | 4 (20) | |
Low glucose | 3 (15) | 2 (10) | |
Low albumin | 7 (35) | 4 | |
Neurological | |||
Headache | 5 (25) | ||
Peripheral neuropathy | 5 (25) | 4 (20) | |
Dizziness | 3 (15) | 1 (5) | |
Pain | |||
Extremity/joint pain | 7 (35) | 1 (5) | |
Other pain | 7 (35) | 3 (15) | |
Pulmonary | |||
Dyspnea | 9 (45) | 3 (15) | 2 (10) |
Cough | 7 (35) | ||
Renal/Electrolytes | |||
High creatinine | 14 (70) | 5 (25) | |
High potassium | 5 (25) | 4 (20) | |
High calcium | 3 (15) | 2 (10) | |
High uric acid | 3 (15) | 1 (5) | 1 (5) |
Low sodium | 3 (15) | ||
Low magnesium | 3 (15) | 3 (15) | |
Hypertension | 3 (15) | 1 (5) | 2 (10) |
Fracture | 1 (5) | 1 (5) |
Abbreviations: ALT = alanine aminotransferase; ANC = absolute neutrophil count; AST = aspartate aminotransferase