Summary of safety of larotrectinib and entrectinib across a variety of TRK fusion-positive tumors in expanded cohorts of treated patients, and label warnings and precautions listed in the United States prescribing information*

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

TRK: tropomyosin receptor kinase; ALT: alanine transaminase; AST: aspartate transaminase; FDA: US Food and Drug Administration.
* All data per United States prescribing information.
¶ Regardless of causality, occurring in at least 10% of patients.

Graphic 126091 Version 2.0

خرید پکیج

Summary of safety of larotrectinib and entrectinib across a variety of TRK fusion-positive tumors in expanded cohorts of treated patients, and label warnings and precautions listed in the United States prescribing information*