Table II.
Toxicity | N in cycle 1* | N in later cycles* | |||||||
---|---|---|---|---|---|---|---|---|---|
Dose level 1 | Dose level 2 | All dose levels | |||||||
Grade | Grade | Grade | |||||||
1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | |
Hematologic | |||||||||
Anemia | 2 | 1 | 3 | 1 | 1 | 1 | 1 | ||
Lymphopenia | 1 | 2 | 1 | 1 | 1 | 1 | 2 | 3 | |
Neutropenia | 1 | 2 | 1 | 1 | 2 | 3 | |||
Thrombocytopenia | 2 | 1 | 1 | 1 | 1 | 1 | 3 | 2 | 1 |
Cardiac | |||||||||
Palpitations | 1 | ||||||||
Constitutional | |||||||||
Fatigue | 1 | 2 | 2 | 2 | |||||
Generalized muscle weakness | 1 | ||||||||
Myalgia | 1 | ||||||||
Pain | 2 | 2 | |||||||
Gastrointestinal | |||||||||
Abdominal pain | 1 | 1 | 1 | ||||||
Constipation | 1 | 1 | 1 | ||||||
Diarrhea | 1 | 1 | 1 | 1 | |||||
Nausea | 2 | 1 | 1 | 1 | 4 | ||||
Vomiting | 1 | 1 | 1 | 2 | |||||
Oral mucositis | 1 | 1 | |||||||
Gum bleeding | 1 | ||||||||
Metabolism/laboratory | |||||||||
Anorexia | 2 | 3 | 1 | 1 | |||||
Dehydration | 1 | ||||||||
Weight loss | 1 | ||||||||
Hypercalcemia | 1 | 2 | |||||||
Hyperkalemia | 1 | ||||||||
Hypermagnesemia | 1 | 1 | |||||||
Hypernatremia | 1 | 1 | |||||||
Hypoalbuminemia | 1 | ||||||||
Hypokalemia | 1 | 1 | 2 | ||||||
Hypomagnesemia | 1 | 1 | 2 | ||||||
Hyponatremia | 1 | ||||||||
Increased ALT | 2 | 1 | |||||||
Increased AST | 1 | 1 | |||||||
Increased alkaline phosphatase | 1 | 2 | 1 | 2 | |||||
Increased bilirubin | 1 | ||||||||
Neurologic/Psychiatric | |||||||||
Dizziness | 1 | 1 | |||||||
Headache | 2 | 1 | 2 | ||||||
Anxiety | 1 | ||||||||
Renal | |||||||||
Proteinurea | 1 | 1 | |||||||
Respiratory | |||||||||
Dyspnea | 1 | ||||||||
Dermatologic | |||||||||
Rash | 1 | 1 | 1 | ||||||
Bruising | 1 | ||||||||
Hearing impairment | 1 |
N=number of patients