SAEs
| SAE term . | Starting dose . | Grade . |
|---|---|---|
| Intracranial hemorrhage after accidental fall | 16.8 mg/m2 | 5 |
| Febrile neutropenia | 16.8 mg/m2 | 3 |
| Blurred vision | 23 mg/m2 | 2 |
| Dehydration | 23 mg/m2 | 3 |
| ALT + AST + alkaline phosphatase + bilirubin increased | 35 mg/m2 | 3 |
| Febrile neutropenia | 45 mg/m2 | 3 |
| Fever | 45 mg/m2 | 3 |
| Hypoxia | 45 mg/m2 | 3 |
| Fever | 60 mg/m2 | 3 |
| Anemia | 45 mg/m2 + 40 mg dex | 3 |
| AST increased | 45 mg/m2 + 4 0mg dex | 4 |
| Fatigue | 45 mg/m2 + 40 mg dex | 3 |
| Dehydration | 60 mg/m2 + 40 mg dex | 3 |
| Delirium | 60 mg/m2 + 40 mg dex | 3 |
| Febrile neutropenia | 60 mg/m2 + 40 mg dex | 3 |
| Hyponatremia | 60 mg/m2 + 40 mg dex | 3 |
| Nausea | 60 mg/m2 + 40 mg dex | 3 |
| Vomiting | 60 mg/m2 + 40 mg dex | 3 |
| Acute kidney injury | 40 mg | 4 |
| Febrile neutropenia | 40 mg | 3 |
| Febrile neutropenia | 40 mg | 3 |
| Sepsis | 40 mg | 4 |
| Encephalopathy | 40 mg | 4 |
| SAE term . | Starting dose . | Grade . |
|---|---|---|
| Intracranial hemorrhage after accidental fall | 16.8 mg/m2 | 5 |
| Febrile neutropenia | 16.8 mg/m2 | 3 |
| Blurred vision | 23 mg/m2 | 2 |
| Dehydration | 23 mg/m2 | 3 |
| ALT + AST + alkaline phosphatase + bilirubin increased | 35 mg/m2 | 3 |
| Febrile neutropenia | 45 mg/m2 | 3 |
| Fever | 45 mg/m2 | 3 |
| Hypoxia | 45 mg/m2 | 3 |
| Fever | 60 mg/m2 | 3 |
| Anemia | 45 mg/m2 + 40 mg dex | 3 |
| AST increased | 45 mg/m2 + 4 0mg dex | 4 |
| Fatigue | 45 mg/m2 + 40 mg dex | 3 |
| Dehydration | 60 mg/m2 + 40 mg dex | 3 |
| Delirium | 60 mg/m2 + 40 mg dex | 3 |
| Febrile neutropenia | 60 mg/m2 + 40 mg dex | 3 |
| Hyponatremia | 60 mg/m2 + 40 mg dex | 3 |
| Nausea | 60 mg/m2 + 40 mg dex | 3 |
| Vomiting | 60 mg/m2 + 40 mg dex | 3 |
| Acute kidney injury | 40 mg | 4 |
| Febrile neutropenia | 40 mg | 3 |
| Febrile neutropenia | 40 mg | 3 |
| Sepsis | 40 mg | 4 |
| Encephalopathy | 40 mg | 4 |
SAEs occurring in the 81 patients with MM and 3 patients with WM in the NCT01607892 study. All SAEs resolved with hospital care with the exception of the intracranial hemorrhage after accidental fall, which was fatal.
ALT, alanine aminotransferase; AST, aspartate aminotransferase.