{"description":"All patients enrolled were included in the all-cause mortality analysis. Forty patients were included in the toxicity analysis (excluding four who did not receive treatment).","eventGroups":[{"deathsNumAffected":36,"deathsNumAtRisk":44,"description":"Patients receive crizotinib 250 mg PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.","id":"EG000","otherNumAffected":33,"otherNumAtRisk":40,"seriousNumAffected":14,"seriousNumAtRisk":40,"title":"Treatment (Crizotinib)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":40}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40}],"term":"Sinus bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders and administration site conditions","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":40}],"term":"Edema limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders and administration site conditions","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":40}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40}],"term":"Rash acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":40}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":40}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":40}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40}],"term":"Gastroesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":40}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":40}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40}],"term":"Upper respiratory infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":40}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":40}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":40}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40}],"term":"Creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":40}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40}],"term":"Weight loss"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40}],"term":"Investigations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":40}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":40}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40}],"term":"Blurred vision"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40}],"term":"Flashing lights"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40}],"term":"Floaters"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40}],"term":"Eye disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40}],"term":"Dyspnea"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":40}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40}],"term":"Sinus bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders and administration site conditions","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":40}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40}],"term":"Bone infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40}],"term":"Bronchial infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40}],"term":"Infections and infestations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40}],"term":"Neoplasms benign, malignant and unspecified (incl cysts and polyps) -"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40}],"term":"Blurred vision"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":40}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":40}],"term":"Hypotension"}],"timeFrame":"Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration."}