Grades 3 to 5 treatment-emergent adverse events occurring with CLAG-M/sorafenib during the first treatment cycle in phase 1 and at the RP2D
| Adverse events based on the organ system class, n (% cycles) . | Phase 1 cohort (n = 46) . | RP2D cohort∗ (n = 41) . |
|---|---|---|
| Blood and lymphatic system disorders† | ||
| Febrile neutropenia | 52 | 40 |
| Infections and infestations | ||
| Bacteremia | 1 | 1 |
| Clostridium difficile | 1 | — |
| Enterocolitis/typhlitis | — | 2 |
| Lung infection | — | 2 |
| Oral infection | 1 | — |
| Sepsis | 2† | — |
| Sinusitis | 1 | 2‡ |
| Skin/soft-tissue infection | 3 | 2 |
| Upper respiratory tract infection | 1 | |
| Cardiac disorders | ||
| Cardiac arrest | — | 1‡ |
| Cardiac troponin increase | 1 | |
| Cardiomyopathy | — | 2 |
| Hypertension | 2 | 2 |
| Hypotension | 1 | — |
| Pericarditis | 1 | — |
| Myocardial infarction | 1 | — |
| Ventricular fibrillation | — | 1‡ |
| Gastrointestinal disorders | ||
| Abdominal pain | — | 1 |
| Colon adenocarcinoma | 1 | — |
| Dental caries/tooth pain | 1 | 1 |
| Diarrhea | 1 | 1 |
| Fistula/fissure, anorectal | 1 | 2 |
| Rectal pain | — | 1 |
| Investigations | ||
| aPTT prolonged | 1 | — |
| Alanine aminotransferase increased | — | 1 |
| Aspartate aminotransferase increased | — | 1 |
| Blood bilirubin increased | 1 | 1 |
| Metabolism and nutrition disorders | ||
| Hyperglycemia | — | 3 |
| Hypokalemia | 1 | 2 |
| Hyponatremia | 2 | — |
| Tumor lysis | 3 | 1 |
| Psychiatric disorders | ||
| Delirium | 1 | — |
| Nervous system disorders | ||
| Depressed level of consciousness | 1† | — |
| Headache | 1 | — |
| Intracranial hemorrhage | 1† | — |
| Paresthesia | — | 1 |
| Seizure | — | 1 |
| Syncope | 1 | 2 |
| Renal and urinary disorders | ||
| Acute kidney injury | — | 1 |
| Hematuria | 1 | — |
| Respiratory, thoracic, and mediastinal disorders | ||
| Hypoxia | — | 1† |
| Pulmonary edema/effusion | — | 2† |
| Pulmonary embolism | 2 | |
| Skin and subcutaneous tissue disorders | ||
| Rash maculo-papular | 17 | 13 |
| Pruritis | — | 1 |
| Other | ||
| Eye disorders: blurred vision | 1 | — |
| Ear and labyrinth disorders: Bell palsy | 1 | — |
| Infusion reaction, blood product | — | 2 |
| Musculoskeletal: joint or extremity pain | 2 | — |
| Vascular: catheter-associated thrombosis | 4 | 3 |
| Adverse events based on the organ system class, n (% cycles) . | Phase 1 cohort (n = 46) . | RP2D cohort∗ (n = 41) . |
|---|---|---|
| Blood and lymphatic system disorders† | ||
| Febrile neutropenia | 52 | 40 |
| Infections and infestations | ||
| Bacteremia | 1 | 1 |
| Clostridium difficile | 1 | — |
| Enterocolitis/typhlitis | — | 2 |
| Lung infection | — | 2 |
| Oral infection | 1 | — |
| Sepsis | 2† | — |
| Sinusitis | 1 | 2‡ |
| Skin/soft-tissue infection | 3 | 2 |
| Upper respiratory tract infection | 1 | |
| Cardiac disorders | ||
| Cardiac arrest | — | 1‡ |
| Cardiac troponin increase | 1 | |
| Cardiomyopathy | — | 2 |
| Hypertension | 2 | 2 |
| Hypotension | 1 | — |
| Pericarditis | 1 | — |
| Myocardial infarction | 1 | — |
| Ventricular fibrillation | — | 1‡ |
| Gastrointestinal disorders | ||
| Abdominal pain | — | 1 |
| Colon adenocarcinoma | 1 | — |
| Dental caries/tooth pain | 1 | 1 |
| Diarrhea | 1 | 1 |
| Fistula/fissure, anorectal | 1 | 2 |
| Rectal pain | — | 1 |
| Investigations | ||
| aPTT prolonged | 1 | — |
| Alanine aminotransferase increased | — | 1 |
| Aspartate aminotransferase increased | — | 1 |
| Blood bilirubin increased | 1 | 1 |
| Metabolism and nutrition disorders | ||
| Hyperglycemia | — | 3 |
| Hypokalemia | 1 | 2 |
| Hyponatremia | 2 | — |
| Tumor lysis | 3 | 1 |
| Psychiatric disorders | ||
| Delirium | 1 | — |
| Nervous system disorders | ||
| Depressed level of consciousness | 1† | — |
| Headache | 1 | — |
| Intracranial hemorrhage | 1† | — |
| Paresthesia | — | 1 |
| Seizure | — | 1 |
| Syncope | 1 | 2 |
| Renal and urinary disorders | ||
| Acute kidney injury | — | 1 |
| Hematuria | 1 | — |
| Respiratory, thoracic, and mediastinal disorders | ||
| Hypoxia | — | 1† |
| Pulmonary edema/effusion | — | 2† |
| Pulmonary embolism | 2 | |
| Skin and subcutaneous tissue disorders | ||
| Rash maculo-papular | 17 | 13 |
| Pruritis | — | 1 |
| Other | ||
| Eye disorders: blurred vision | 1 | — |
| Ear and labyrinth disorders: Bell palsy | 1 | — |
| Infusion reaction, blood product | — | 2 |
| Musculoskeletal: joint or extremity pain | 2 | — |
| Vascular: catheter-associated thrombosis | 4 | 3 |
Hematologic treatment-emergent adverse events were not collected, except for febrile neutropenia and bleeding events ≥grade 3.
Six patients are represented in both the phase 1 and RP2D cohorts.
One of the events is a grade 4 event.
One of the events is a grade 5 event: 1 each for the adverse events marked.