{"description":"All 5 cases that received protocol treatment were monitored for adverse events.","eventGroups":[{"deathsNumAffected":4,"deathsNumAtRisk":5,"description":"Patients receive crizotinib 250 mg PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity\n\nCrizotinib: Given PO","id":"EG000","otherNumAffected":5,"otherNumAtRisk":5,"seriousNumAffected":2,"seriousNumAtRisk":5,"title":"Treatment (Crizotinib)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5}],"term":"Sinus bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Edema limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"General disorders and administration site conditions - Other"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Rash acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":5}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":5}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Gastrointestinal disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":5}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":5}],"term":"Alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Investigations - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5}],"term":"Hypoalbuminemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Hypoglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Flashing lights"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Photophobia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Eye disorders - Other, specify"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Nasal congestion"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":5}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE 4.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":5}],"term":"Hypophosphatemia"}],"timeFrame":"Assessed every 28 days while on treatment and for 30 days after the end of treatment, up to 3 years post registration."}