Summary of adverse events in phase 1+2, reported as number of patients, the highest grade per patient
| . | G1 . | G2 . | G3 . | G4 . | G5 . |
|---|---|---|---|---|---|
| Hematologic | |||||
| Anemia | 29 | 14 | 2 | 1 | |
| Neutropenia | 4 | 11 | 27 | ||
| Thrombocytopenia | 15 | 8 | 9 | 1 | |
| Nonhematologic | |||||
| Infection | 2 | 6 | 13 | 6 | 2 |
| Cutaneous | |||||
| Rash | 10 | 8 | 9 | ||
| Immune system disorders | |||||
| Allergic reaction | 1 | 6 | 6 | ||
| Cytokine release syndrome | 1 | ||||
| Gastrointestinal | |||||
| Abdominal pain | 1 | ||||
| Abdominal distention | 1 | ||||
| Constipation | 3 | 4 | |||
| Diarrhea | 5 | 2 | |||
| Hemorrhoids/rectal bleeding | 4 | ||||
| Mucositis/esophagitis | 2 | 7 | 3 | ||
| Nausea/vomiting | 9 | 4 | 2 | ||
| Respiratory tract | |||||
| Cough | 1 | ||||
| Dyspnea | 2 | 1 | |||
| Cardiac | |||||
| Acute coronary syndrome | 1 | ||||
| Arrhythmia/conduction disorder | 1 | 4 | 1 | ||
| Neurologic/psychiatric | |||||
| Cerebral infarction | 1 | ||||
| Confusion | 1 | ||||
| Dizziness | 3 | ||||
| Dysgeusia | 1 | ||||
| Headache | 3 | ||||
| Neuropathy | 4 | 1 | |||
| Syncope | 1 | ||||
| Insomnia | 1 | ||||
| Musculoskeletal | |||||
| Gout | 1 | ||||
| Joint effusion | 1 | ||||
| Musculoskeletal pain | 4 | 5 | 3 | ||
| Hepatobiliary disorders | |||||
| Cholecystitis | 1 | ||||
| Hepatic failure | 1 | ||||
| Hypoalbuminemia | 1 | 2 | 0 | ||
| Alkaline phosphatase elevation | 2 | 1 | 1 | ||
| Aminotransferase elevation | 2 | ||||
| γ-GT elevation | 1 | 1 | |||
| Vascular | |||||
| Flushing | 1 | ||||
| Hypotension | 1 | 1 | 2 | ||
| Phlebitis | 2 | ||||
| Thromboembolic event | 3 | ||||
| Renal and urinary | |||||
| Creatinine elevation | 2 | ||||
| Hematuria | 2 | ||||
| Urinary tract obstruction | 1 | ||||
| Other renal and urinary symptoms | 4 | 3 | 1 | ||
| General | |||||
| Anorexia | 4 | 2 | 3 | ||
| Chills | 4 | ||||
| Edema | 2 | 3 | 1 | ||
| Fatigue | 8 | 3 | 2 | ||
| Fever | 5 | 6 | 1 | ||
| Weight loss | 2 | 4 | 1 | ||
| Weight gain | 1 | ||||
| Hyperglycemia | 1 | ||||
| Sweating | 1 | ||||
| Visual disturbance | 1 | ||||
| Dry eyes | 1 | ||||
| Tumor lysis syndrome | 2 |
| . | G1 . | G2 . | G3 . | G4 . | G5 . |
|---|---|---|---|---|---|
| Hematologic | |||||
| Anemia | 29 | 14 | 2 | 1 | |
| Neutropenia | 4 | 11 | 27 | ||
| Thrombocytopenia | 15 | 8 | 9 | 1 | |
| Nonhematologic | |||||
| Infection | 2 | 6 | 13 | 6 | 2 |
| Cutaneous | |||||
| Rash | 10 | 8 | 9 | ||
| Immune system disorders | |||||
| Allergic reaction | 1 | 6 | 6 | ||
| Cytokine release syndrome | 1 | ||||
| Gastrointestinal | |||||
| Abdominal pain | 1 | ||||
| Abdominal distention | 1 | ||||
| Constipation | 3 | 4 | |||
| Diarrhea | 5 | 2 | |||
| Hemorrhoids/rectal bleeding | 4 | ||||
| Mucositis/esophagitis | 2 | 7 | 3 | ||
| Nausea/vomiting | 9 | 4 | 2 | ||
| Respiratory tract | |||||
| Cough | 1 | ||||
| Dyspnea | 2 | 1 | |||
| Cardiac | |||||
| Acute coronary syndrome | 1 | ||||
| Arrhythmia/conduction disorder | 1 | 4 | 1 | ||
| Neurologic/psychiatric | |||||
| Cerebral infarction | 1 | ||||
| Confusion | 1 | ||||
| Dizziness | 3 | ||||
| Dysgeusia | 1 | ||||
| Headache | 3 | ||||
| Neuropathy | 4 | 1 | |||
| Syncope | 1 | ||||
| Insomnia | 1 | ||||
| Musculoskeletal | |||||
| Gout | 1 | ||||
| Joint effusion | 1 | ||||
| Musculoskeletal pain | 4 | 5 | 3 | ||
| Hepatobiliary disorders | |||||
| Cholecystitis | 1 | ||||
| Hepatic failure | 1 | ||||
| Hypoalbuminemia | 1 | 2 | 0 | ||
| Alkaline phosphatase elevation | 2 | 1 | 1 | ||
| Aminotransferase elevation | 2 | ||||
| γ-GT elevation | 1 | 1 | |||
| Vascular | |||||
| Flushing | 1 | ||||
| Hypotension | 1 | 1 | 2 | ||
| Phlebitis | 2 | ||||
| Thromboembolic event | 3 | ||||
| Renal and urinary | |||||
| Creatinine elevation | 2 | ||||
| Hematuria | 2 | ||||
| Urinary tract obstruction | 1 | ||||
| Other renal and urinary symptoms | 4 | 3 | 1 | ||
| General | |||||
| Anorexia | 4 | 2 | 3 | ||
| Chills | 4 | ||||
| Edema | 2 | 3 | 1 | ||
| Fatigue | 8 | 3 | 2 | ||
| Fever | 5 | 6 | 1 | ||
| Weight loss | 2 | 4 | 1 | ||
| Weight gain | 1 | ||||
| Hyperglycemia | 1 | ||||
| Sweating | 1 | ||||
| Visual disturbance | 1 | ||||
| Dry eyes | 1 | ||||
| Tumor lysis syndrome | 2 |