Table 2.
Treatment-emergent adverse events (safety analysis)
| TEAEs type | Total (N = 50) n (%) |
|---|---|
| Total participants with an event | 25 (50.0) |
| Gastrointestinal disorders | 8 (16.0) |
| Abdominal pain | 3 (6.0) |
| Nausea | 3 (6.0) |
| Vomiting | 3 (6.0) |
| Abdominal pain upper | 1 (2.0) |
| Ascites | 1 (2.0) |
| Gingival bleeding | 1 (2.0) |
| Hematochezia | 1 (2.0) |
| Blood investigations abnormality | 8 (16.0) |
| Alanine aminotransferase increased | 4 (8.0) |
| Aspartate aminotransferase increased | 4 (8.0) |
| WBC count decreased | 4 (8.0) |
| Neutrophil count decreased | 3 (6.0) |
| Blood bilirubin increased | 2 (4.0) |
| Bilirubin conjugated increased | 1 (2.0) |
| Blood bilirubin unconjugated increased | 1 (2.0) |
| Blood fibrinogen decreased | 1 (2.0) |
| Coagulation test abnormal | 1 (2.0) |
| Gamma-glutamyltransferase increased | 1 (2.0) |
| Metabolism and nutrition disorders | 8 (16.0) |
| Hypokalemia | 5 (10.0) |
| Hyponatremia | 2 (4.0) |
| TLS | 2 (4.0) |
| Hypocalcemia | 1 (2.0) |
| Hypophosphatemia | 1 (2.0) |
| General disorders and administration site conditions | 7 (14.0) |
| Pyrexia | 6 (12.0) |
| Asthenia | 1 (2.0) |
| Chest discomfort | 1 (2.0) |
| Blood and lymphatic system disorders | 5 (10.0) |
| Anemia | 3 (6.0) |
| Febrile neutropenia | 1 (2.0) |
| Hypercoagulation | 1 (2.0) |
| Hepatobiliary disorders | 4 (8.0) |
| Hepatic function abnormal | 3 (6.0) |
| Cholelithiasis | 1 (2.0) |
| Infections and infestations | 2 (4.0) |
| Pneumonia | 2 (4.0) |
| Nervous system disorders | 2 (4.0) |
| Headache | 2 (4.0) |
| Dizziness | 1 (2.0) |
| Respiratory, thoracic and mediastinal disorders | 2 (4.0) |
| Cough | 1 (2.0) |
| Pleural effusion | 1 (2.0) |
| Cardiac disorders | 1 (2.0) |
| Sinus bradycardia | 1 (2.0) |
| Eye disorders | 1 (2.0) |
| Eyelid oedema | 1 (2.0) |
| Immune system disorders | 1 (2.0) |
| Anaphylactic shock | 1 (2.0) |
| Injury, poisoning and procedural complications | 1 (2.0) |
| Refractoriness to platelet transfusion | 1 (2.0) |
| Musculoskeletal and connective tissue disorders | 1 (2.0) |
| Back pain | 1 (2.0) |
| TEAEs leading to treatment discontinuation | 3 (6.0) |
| Hepatobiliary disorders (abnormal hepatic function) | 1 (2.0) |
| Immune system disorders (anaphylactic shock) | 1 (2.0) |
| Metabolism and nutritional disorders (TLS) | 1 (2.0) |
| Most common (≥ 5%) TEAEs | |
| Total participants with an event | 20 (40.0) |
| Pyrexia | 6 (12.0) |
| Hypokalemia | 5 (10.0) |
| Alanine aminotransferase increased | 4 (8.0) |
| Aspartate aminotransferase increased | 4 (8.0) |
| WBC count decreased | 4 (8.0) |
| Abdominal pain | 3 (6.0) |
| Anemia | 3 (6.0) |
| Hepatic function abnormal | 3 (6.0) |
| Nausea | 3 (6.0) |
| Neutrophil count decreased | 3 (6.0) |
| Vomiting | 3 (6.0) |
TEAE treatment emergent adverse event, TLS tumor lysis syndrome, WBC white blood cell count