Table 2.
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