Larotrectinib (n = 176 patients) | Entrectinib (n = 355 patients) |
Adverse events¶ | All grades (%) | Grades 3/4 (%) | Adverse events¶ | All grades (%) | Grades 3/4 (%) |
Chemistry | Chemistry |
Increased ALT | 45 | 3 | Increased ALT | 38 | 2.9 |
Increased AST | 45 | 3 | Increased AST | 44 | 2.7 |
Increased alkaline phosphatase | 30 | 3 | Increased creatinine | 73 | 2.1 |
| Hyperuricemia | 52 | 10 |
Hypernatremia | 35 | 0.9 |
Hypocalcemia | 34 | 1.8 |
Hypophosphatemia | 30 | 7 |
Eye | Eye |
| Vision disorders | 21 | 0.8 |
Gastrointestinal | Gastrointestinal |
Nausea | 29 | 1 | Nausea | 34 | 0.3 |
Vomiting | 26 | 1 | Vomiting | 24 | 0.8 |
Constipation | 23 | 1 | Constipation | 46 | 0.6 |
Diarrhea | 22 | 2 | Diarrhea | 35 | 2.0 |
General | General |
Fatigue | 37 | 3 | Fatigue | 28 | 5 |
Pyrexia | 18 | 1 | Pyrexia | 21 | 0.8 |
Edema, peripheral | 15 | 0 | Edema | 40 | 1.1 |
Hematology | Hematology |
Anemia | 42 | 10 | Anemia | 67 | 9 |
Neutropenia | 23 | 7 | Neutropenia | 28 | 7 |
| Lymphopenia | 40 | 12 |
Metabolism and nutrition | Metabolism and nutrition |
Decreased appetite | 13 | 2 | Decreased appetite | 13 | 0.3 |
| Increased weight | 25 | 7 |
Musculoskeletal and connective tissue | Musculoskeletal and connective tissue |
Arthralgia | 14 | 1 | Arthralgia | 21 | 0.6 |
Myalgia | 14 | 1 | Myalgia | 28 | 1.1 |
Nervous system | Nervous system |
Dizziness | 28 | 1 | Dizziness | 38 | 0.8 |
Headache | 14 | 0 | Headache | 18 | 0.3 |
| Dysgeusia | 44 | 0.3 |
Dysesthesia | 34 | 0.3 |
Cognitive impairment | 27 | 4.5 |
Peripheral sensory neuropathy | 18 | 1.1 |
Ataxia | 17 | 0.8 |
Sleep | 14 | 0.6 |
Mood disorders | 10 | 0.6 |
Respiratory, thoracic, and mediastinal | Respiratory, thoracic, and mediastinal |
Cough | 26 | 0 | Cough | 24 | 0.3 |
Dyspnea | 18 | 2 | Dyspnea | 30 | 6 |
Skin and subcutaneous tissue | Skin and subcutaneous tissue |
| Rash | 11 | 0.8 |
Vascular | Vascular |
Hypertension | 11 | 2 | Hypotension | 18 | 2.8 |
FDA prescribing information warnings and precautions | FDA prescribing information warnings and precautions |
Neurotoxicity, hepatotoxicity, embryo-fetal toxicity | Congestive heart failure, central nervous system effects, skeletal fractures, hepatotoxicity, hyperuricemia, QT interval prolongation, vision disorders, embryo-fetal toxicity |