Table 4.
Adverse events | Grade 3 [n (%)] | Grade 4 [n(%)] | Grade 5 [n(%)] |
---|---|---|---|
Hematological | |||
Anemia | 13 (7.1) | 1 (0.5) | |
Leucopenia | 16 (8.7) | 28 (15.3) | |
Thrombocytopenia | 26 (14.2) | 26 (14.2) | |
Hepatic | |||
Increased AST | 12 (6.6) | 2 (1.1) | |
Increased ALT | 10 (5.4) | 2 (1.1) | |
Increased bilirubin | 4 (2.2) | ||
Gastrointestinal | |||
Gastric ulcer | 1 (0.5) | ||
Vascular | |||
Pulmonary embolism | 5 (2.7) | ||
Cardiac | |||
Cardiac ischemia | 1 (0.5) | ||
Metabolism and nutrition | |||
Hyperglycemia | 1 (0.5) | ||
Tumor lysis syndrome | 1 (0.5) | ||
Renal/urinary | |||
Acute kidney injury | 3 (1.6) | ||
Infections | |||
Vulvar infection | 1 (0.5) | ||
Sepsis | 1 (0.5) | ||
Febrile neutropenia | 5 (2.7) | ||
Others | 1 (0.5) | ||
Nervous system | |||
Vasovagal reaction | 2 (1.1) | ||
Stroke | 5 (2.7) | ||
General disorders | |||
Fatigue | 1 (0.5) | ||
Death | 2 (1.1) |
AST aspartate aminotransferase, ALT alanine aminotransferase