Grades 1 and 2 AEs occurring in >10% of patients and all grade 3-4 AEs
| . | All attributions (N = 37) . | |||
|---|---|---|---|---|
| Grade 1-2 . | Grade 3-4 . | |||
| AE . | n . | % . | n . | % . |
| Blood and lymphatic system | ||||
| Neutropenia | 24 | 65 | 22 | 59 |
| Lymphocytopenia | 22 | 59 | 16 | 43 |
| Leukopenia | 27 | 73 | 12 | 32 |
| Thrombocytopenia | 26 | 70 | 10 | 27 |
| Anemia | 26 | 70 | 9 | 24 |
| Leukocytosis | 1 | 3 | 7 | 19 |
| Febrile neutropenia | 0 | 0 | 3 | 8 |
| Cardiac disorders | ||||
| Pericardial effusion | 0 | 0 | 1 | 3 |
| Others | 0 | 0 | 1 | 3 |
| Gastrointestinal | ||||
| Diarrhea | 10 | 27 | 2 | 5 |
| Nausea | 13 | 35 | 1 | 3 |
| Vomiting | 9 | 24 | 1 | 3 |
| Abdominal pain | 6 | 16 | 1 | 3 |
| Stomach pain | 2 | 5 | 1 | 3 |
| Constipation | 5 | 14 | 0 | 0 |
| Infection | ||||
| Bacteremia | 0 | 0 | 2 | 5 |
| Sepsis | 0 | 0 | 2 | 5 |
| Upper respiratory infection | 6 | 16 | 1 | 3 |
| Tooth infection | 2 | 5 | 1 | 3 |
| Urinary tract infection | 2 | 5 | 1 | 3 |
| Lung infection | 0 | 0 | 1 | 3 |
| Laboratory | ||||
| Increased alkaline phosphatase | 13 | 35 | 1 | 3 |
| Increased ALT | 12 | 32 | 1 | 3 |
| Increased bilirubin | 8 | 22 | 1 | 3 |
| Increased INR | 4 | 11 | 1 | 3 |
| Prolonged pTT | 2 | 5 | 1 | 3 |
| Increased AST | 15 | 41 | 0 | 0 |
| Increased creatinine | 9 | 24 | 0 | 0 |
| Metabolic | ||||
| Hypokalemia | 20 | 54 | 10 | 27 |
| Hypoalbuminemia | 22 | 59 | 3 | 8 |
| Hypophosphatemia | 3 | 8 | 2 | 5 |
| Hypocalcemia | 23 | 62 | 1 | 3 |
| Hyponatremia | 9 | 24 | 0 | 0 |
| Hypercalcemia | 6 | 16 | 0 | 0 |
| Hypomagnesemia | 5 | 14 | 0 | 0 |
| Hyperkalemia | 5 | 14 | 0 | 0 |
| Neurological | ||||
| Syncope | 0 | 0 | 2 | 5 |
| Peripheral sensory neuropathy | 15 | 41 | 1 | 3 |
| Dizziness | 8 | 22 | 0 | 0 |
| Dysgeusia | 4 | 11 | 0 | 0 |
| Renal | ||||
| Dyspnea | 14 | 38 | 1 | 3 |
| Acute kidney disease | 2 | 5 | 1 | 3 |
| Chronic kidney disease | 2 | 5 | 1 | 3 |
| Urinary tract obstruction | 0 | 0 | 1 | 3 |
| Hematuria | 4 | 11 | 0 | 0 |
| Pulmonary | ||||
| COPD | 1 | 3 | 1 | 3 |
| Hypoxia | 0 | 0 | 1 | 3 |
| Stridor | 0 | 0 | 1 | 3 |
| Cough | 9 | 24 | 0 | 0 |
| Skin | ||||
| Maculopapular rash | 17 | 46 | 9 | 24 |
| Cellulitis | 0 | 0 | 1 | 3 |
| Pruritus | 5 | 14 | 0 | 0 |
| Vascular | ||||
| Thromboembolism | 0 | 0 | 3 | 8 |
| Hypotension | 3 | 8 | 1 | 3 |
| Others | ||||
| Fatigue | 15 | 41 | 3 | 8 |
| Anorexia | 12 | 32 | 1 | 3 |
| Dehydration | 5 | 14 | 1 | 3 |
| Pain | 5 | 14 | 1 | 3 |
| Neck pain | 2 | 5 | 1 | 3 |
| Flank pain | 2 | 5 | 1 | 3 |
| Arthritis | 0 | 0 | 1 | 3 |
| Noncardiac pain | 1 | 3 | 1 | 3 |
| Multiorgan failure | 0 | 0 | 1 | 3 |
| Fever | 13 | 35 | 0 | 0 |
| Weight loss | 10 | 27 | 0 | 0 |
| Edema (limb) | 5 | 14 | 0 | 0 |
| Arthralgia | 4 | 11 | 0 | 0 |
| . | All attributions (N = 37) . | |||
|---|---|---|---|---|
| Grade 1-2 . | Grade 3-4 . | |||
| AE . | n . | % . | n . | % . |
| Blood and lymphatic system | ||||
| Neutropenia | 24 | 65 | 22 | 59 |
| Lymphocytopenia | 22 | 59 | 16 | 43 |
| Leukopenia | 27 | 73 | 12 | 32 |
| Thrombocytopenia | 26 | 70 | 10 | 27 |
| Anemia | 26 | 70 | 9 | 24 |
| Leukocytosis | 1 | 3 | 7 | 19 |
| Febrile neutropenia | 0 | 0 | 3 | 8 |
| Cardiac disorders | ||||
| Pericardial effusion | 0 | 0 | 1 | 3 |
| Others | 0 | 0 | 1 | 3 |
| Gastrointestinal | ||||
| Diarrhea | 10 | 27 | 2 | 5 |
| Nausea | 13 | 35 | 1 | 3 |
| Vomiting | 9 | 24 | 1 | 3 |
| Abdominal pain | 6 | 16 | 1 | 3 |
| Stomach pain | 2 | 5 | 1 | 3 |
| Constipation | 5 | 14 | 0 | 0 |
| Infection | ||||
| Bacteremia | 0 | 0 | 2 | 5 |
| Sepsis | 0 | 0 | 2 | 5 |
| Upper respiratory infection | 6 | 16 | 1 | 3 |
| Tooth infection | 2 | 5 | 1 | 3 |
| Urinary tract infection | 2 | 5 | 1 | 3 |
| Lung infection | 0 | 0 | 1 | 3 |
| Laboratory | ||||
| Increased alkaline phosphatase | 13 | 35 | 1 | 3 |
| Increased ALT | 12 | 32 | 1 | 3 |
| Increased bilirubin | 8 | 22 | 1 | 3 |
| Increased INR | 4 | 11 | 1 | 3 |
| Prolonged pTT | 2 | 5 | 1 | 3 |
| Increased AST | 15 | 41 | 0 | 0 |
| Increased creatinine | 9 | 24 | 0 | 0 |
| Metabolic | ||||
| Hypokalemia | 20 | 54 | 10 | 27 |
| Hypoalbuminemia | 22 | 59 | 3 | 8 |
| Hypophosphatemia | 3 | 8 | 2 | 5 |
| Hypocalcemia | 23 | 62 | 1 | 3 |
| Hyponatremia | 9 | 24 | 0 | 0 |
| Hypercalcemia | 6 | 16 | 0 | 0 |
| Hypomagnesemia | 5 | 14 | 0 | 0 |
| Hyperkalemia | 5 | 14 | 0 | 0 |
| Neurological | ||||
| Syncope | 0 | 0 | 2 | 5 |
| Peripheral sensory neuropathy | 15 | 41 | 1 | 3 |
| Dizziness | 8 | 22 | 0 | 0 |
| Dysgeusia | 4 | 11 | 0 | 0 |
| Renal | ||||
| Dyspnea | 14 | 38 | 1 | 3 |
| Acute kidney disease | 2 | 5 | 1 | 3 |
| Chronic kidney disease | 2 | 5 | 1 | 3 |
| Urinary tract obstruction | 0 | 0 | 1 | 3 |
| Hematuria | 4 | 11 | 0 | 0 |
| Pulmonary | ||||
| COPD | 1 | 3 | 1 | 3 |
| Hypoxia | 0 | 0 | 1 | 3 |
| Stridor | 0 | 0 | 1 | 3 |
| Cough | 9 | 24 | 0 | 0 |
| Skin | ||||
| Maculopapular rash | 17 | 46 | 9 | 24 |
| Cellulitis | 0 | 0 | 1 | 3 |
| Pruritus | 5 | 14 | 0 | 0 |
| Vascular | ||||
| Thromboembolism | 0 | 0 | 3 | 8 |
| Hypotension | 3 | 8 | 1 | 3 |
| Others | ||||
| Fatigue | 15 | 41 | 3 | 8 |
| Anorexia | 12 | 32 | 1 | 3 |
| Dehydration | 5 | 14 | 1 | 3 |
| Pain | 5 | 14 | 1 | 3 |
| Neck pain | 2 | 5 | 1 | 3 |
| Flank pain | 2 | 5 | 1 | 3 |
| Arthritis | 0 | 0 | 1 | 3 |
| Noncardiac pain | 1 | 3 | 1 | 3 |
| Multiorgan failure | 0 | 0 | 1 | 3 |
| Fever | 13 | 35 | 0 | 0 |
| Weight loss | 10 | 27 | 0 | 0 |
| Edema (limb) | 5 | 14 | 0 | 0 |
| Arthralgia | 4 | 11 | 0 | 0 |
ALT, alanine aminotransferase; AST, aspartate aminotransferase; COPD, chronic obstructive pulmonary disease; INR, international normalized ratio; pTT, partial thromboplastin time.