{"description":"Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the \"AE Other\" table. Ineligible patients are excluded from reporting of adverse events. All-Cause Mortality includes all deaths collected on the study.","eventGroups":[{"deathsNumAffected":3,"deathsNumAtRisk":9,"description":"Patients receive larotrectinib sulfate PO or via NG- or G-tube BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients undergo a CT scan, MRI, an x-ray, bone scan, and/or MIBG scintigraphy during screening and on study. Patients also undergo bone marrow aspiration and/or biopsy during screening and may undergo blood sample collection on study.","id":"EG000","otherNumAffected":7,"otherNumAtRisk":9,"seriousNumAffected":2,"seriousNumAtRisk":9,"title":"Treatment (Larotrectinib Sulfate)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":9}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Blood and lymphatic system disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Sinus bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":9}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Eye disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Scleral disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Gastroesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Gastrointestinal disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Mucositis/stomatitis (functional/symptomatic) - Oral cavity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":9}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Toothache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":9}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":9}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":9}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Flu like symptoms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"General disorders and administration site conditions - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Localized edema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Allergic reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Otitis media"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Rhinitis infective"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Upper respiratory infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Bruising"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Vascular access complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":9}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Blood bicarbonate decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Blood lactate dehydrogenase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Hemoglobin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Investigations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":9}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":9}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":9}],"term":"Weight gain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":9}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":9}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":9}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Hyperkalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Hypermagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":9}],"term":"Hyperphosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":9}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Hypoglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Hypophosphatemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Chest wall pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Musculoskeletal and connective tissue disorder - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":9}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Lethargy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Paresthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Irritability"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Psychiatric disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Urinary frequency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Atelectasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Nasal congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Postnasal drip"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Rhinorrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Sneezing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Sore throat"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Hyperhidrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Rash acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":9}],"term":"Skin and subcutaneous tissue disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Skin hypopigmentation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Flushing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Hematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Disease progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Depressed level of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":9}],"term":"Hypoglycemia"}],"timeFrame":"Adverse Events monitored/assessed from enrollment to 30 days after the end of treatment, up to 2 years. All-Cause Mortality monitored/assessed up to 5 years"}