ATO related non-hematological toxicities during cycle 1
| Toxicity . | Dose level (number of evaluable patients) . | |||||||
|---|---|---|---|---|---|---|---|---|
| 0.15 mg/kg (n = 15) . | 0.2 mg/kg (n = 4) . | |||||||
| 1 . | 2 . | 3 . | 4 . | 1 . | 2 . | 3 . | 4 . | |
| Allergy | ||||||||
| Hypersensitivity | — | — | 1 | — | — | — | — | — |
| Urticaria/hives | 1 | — | — | — | — | — | — | — |
| Cardiovascular | ||||||||
| Prolonged QTc | 1* | — | — | — | 1* | — | — | — |
| Sinus tachycardia | — | 1 | — | — | — | — | — | — |
| Hypotension | — | 1 | — | — | — | 1 | — | — |
| Vascular leak syndrome§ | — | — | — | 1† | — | — | — | — |
| Coagulation | ||||||||
| Prolonged PT | 1 | — | — | — | — | — | — | — |
| Prolonged PTT | 1 | — | — | — | — | — | — | — |
| Elevated fibrinogen | — | 1 | — | — | — | — | — | — |
| Constitutional | ||||||||
| Fever (no neutropenia) | 1 | 1 | 1 | — | — | — | — | — |
| Nasal congestion | 1 | — | — | — | — | — | — | — |
| Myalgia | — | 1 | — | — | — | — | — | — |
| Dermatological | ||||||||
| Rash/dermatitis | 3 | — | — | — | — | — | — | — |
| Dry skin | 1 | — | — | — | — | — | — | — |
| Gastrointestinal | ||||||||
| Anorexia | 1 | — | 1† | — | — | — | — | — |
| Constipation | 1 | 2† | — | — | — | — | — | — |
| Vomiting | 5 | — | — | — | — | — | — | — |
| Nausea | 3† | 1 | — | — | 1 | — | — | — |
| Diarrhea | 1 | 1 | — | — | — | — | — | — |
| Pancreatitis | — | — | — | — | — | — | — | 1‡ |
| Stomatitis | 1† | 1 | — | — | — | — | — | — |
| Typhlitis | — | — | 1 | — | — | — | — | — |
| Hepatic | ||||||||
| Elevated AST (SGOT) | 5 | 1 | 1 | — | — | — | — | 1‡ |
| Elevated ALT (SGPT) | 4 | 1 | 1 | — | — | 1‡ | — | — |
| Elevated GGT | — | 1 | — | — | — | — | — | — |
| Elevated alkaline phos | 1 | — | — | — | — | — | — | — |
| Hyperbilirubinemia | — | — | — | — | 1‡ | — | — | — |
| Infection§ | ||||||||
| Infection (no neutropenia) | — | — | 3 | — | — | — | — | — |
| Febrile neutropenia | — | — | 1 | — | — | — | — | — |
| Metabolic | ||||||||
| Elevated Amylase | — | — | — | — | — | — | 1‡ | — |
| Hypokalemia§ | 1 | — | 1 | — | — | — | — | — |
| Hyponatremia | 2 | — | — | — | — | — | 1‡ | — |
| Hypomagnesemia | 4 | 1† | — | — | — | — | — | — |
| Hypocalcemia | 3 | 2 | — | — | — | — | — | — |
| Hypophosphatemia | 1 | 1† | — | — | — | — | — | — |
| Hyperphosphatemia | 1 | — | — | — | — | — | — | — |
| Hypoglycemia | 1 | — | — | — | — | — | — | — |
| Hyperglycemia | 3 | 1 | 1 | 1† | — | — | — | — |
| Elevated lipase | — | — | — | — | — | — | — | 1‡ |
| Hypoalbuminemia | 1 | — | 1 | — | — | — | — | — |
| Decreased total protein | 1 | — | — | — | — | — | — | — |
| Neurological | ||||||||
| Motor neuropathy | 1 | — | — | — | — | — | — | — |
| Sensory neuropathy | 1 | 1 | — | — | — | — | — | — |
| Ocular | ||||||||
| Conjunctivitis | 1 | — | — | — | 1 | — | — | — |
| Periorbital edema | — | — | — | — | 1 | — | — | — |
| Pain | ||||||||
| Abdominal cramping | 1 | 1 | — | — | — | — | — | 1‡ |
| Headache | 3 | — | — | — | — | — | — | — |
| Neuropathic pain | — | 1 | 1† | — | — | — | — | — |
| Pulmonary, pneumonitis | — | — | — | 1† | — | — | — | — |
| Toxicity . | Dose level (number of evaluable patients) . | |||||||
|---|---|---|---|---|---|---|---|---|
| 0.15 mg/kg (n = 15) . | 0.2 mg/kg (n = 4) . | |||||||
| 1 . | 2 . | 3 . | 4 . | 1 . | 2 . | 3 . | 4 . | |
| Allergy | ||||||||
| Hypersensitivity | — | — | 1 | — | — | — | — | — |
| Urticaria/hives | 1 | — | — | — | — | — | — | — |
| Cardiovascular | ||||||||
| Prolonged QTc | 1* | — | — | — | 1* | — | — | — |
| Sinus tachycardia | — | 1 | — | — | — | — | — | — |
| Hypotension | — | 1 | — | — | — | 1 | — | — |
| Vascular leak syndrome§ | — | — | — | 1† | — | — | — | — |
| Coagulation | ||||||||
| Prolonged PT | 1 | — | — | — | — | — | — | — |
| Prolonged PTT | 1 | — | — | — | — | — | — | — |
| Elevated fibrinogen | — | 1 | — | — | — | — | — | — |
| Constitutional | ||||||||
| Fever (no neutropenia) | 1 | 1 | 1 | — | — | — | — | — |
| Nasal congestion | 1 | — | — | — | — | — | — | — |
| Myalgia | — | 1 | — | — | — | — | — | — |
| Dermatological | ||||||||
| Rash/dermatitis | 3 | — | — | — | — | — | — | — |
| Dry skin | 1 | — | — | — | — | — | — | — |
| Gastrointestinal | ||||||||
| Anorexia | 1 | — | 1† | — | — | — | — | — |
| Constipation | 1 | 2† | — | — | — | — | — | — |
| Vomiting | 5 | — | — | — | — | — | — | — |
| Nausea | 3† | 1 | — | — | 1 | — | — | — |
| Diarrhea | 1 | 1 | — | — | — | — | — | — |
| Pancreatitis | — | — | — | — | — | — | — | 1‡ |
| Stomatitis | 1† | 1 | — | — | — | — | — | — |
| Typhlitis | — | — | 1 | — | — | — | — | — |
| Hepatic | ||||||||
| Elevated AST (SGOT) | 5 | 1 | 1 | — | — | — | — | 1‡ |
| Elevated ALT (SGPT) | 4 | 1 | 1 | — | — | 1‡ | — | — |
| Elevated GGT | — | 1 | — | — | — | — | — | — |
| Elevated alkaline phos | 1 | — | — | — | — | — | — | — |
| Hyperbilirubinemia | — | — | — | — | 1‡ | — | — | — |
| Infection§ | ||||||||
| Infection (no neutropenia) | — | — | 3 | — | — | — | — | — |
| Febrile neutropenia | — | — | 1 | — | — | — | — | — |
| Metabolic | ||||||||
| Elevated Amylase | — | — | — | — | — | — | 1‡ | — |
| Hypokalemia§ | 1 | — | 1 | — | — | — | — | — |
| Hyponatremia | 2 | — | — | — | — | — | 1‡ | — |
| Hypomagnesemia | 4 | 1† | — | — | — | — | — | — |
| Hypocalcemia | 3 | 2 | — | — | — | — | — | — |
| Hypophosphatemia | 1 | 1† | — | — | — | — | — | — |
| Hyperphosphatemia | 1 | — | — | — | — | — | — | — |
| Hypoglycemia | 1 | — | — | — | — | — | — | — |
| Hyperglycemia | 3 | 1 | 1 | 1† | — | — | — | — |
| Elevated lipase | — | — | — | — | — | — | — | 1‡ |
| Hypoalbuminemia | 1 | — | 1 | — | — | — | — | — |
| Decreased total protein | 1 | — | — | — | — | — | — | — |
| Neurological | ||||||||
| Motor neuropathy | 1 | — | — | — | — | — | — | — |
| Sensory neuropathy | 1 | 1 | — | — | — | — | — | — |
| Ocular | ||||||||
| Conjunctivitis | 1 | — | — | — | 1 | — | — | — |
| Periorbital edema | — | — | — | — | 1 | — | — | — |
| Pain | ||||||||
| Abdominal cramping | 1 | 1 | — | — | — | — | — | 1‡ |
| Headache | 3 | — | — | — | — | — | — | — |
| Neuropathic pain | — | 1 | 1† | — | — | — | — | — |
| Pulmonary, pneumonitis | — | — | — | 1† | — | — | — | — |