{"eventGroups":[{"deathsNumAffected":12,"deathsNumAtRisk":12,"description":"Patients receive PI3K inhibitor BKM120 PO QD 100 mg/day on days -7 to 0. Patients complete 1 week washout. After dose escalation phase, 3 patients receive BKM120 PO 80mg / day and cetuximab 500 mg IV /14 days and 9 patients receive BKM120 PO 100mg / day and cetuximab 500 mg IV /14 days thereafter.\n\nAll patients receive PI3K inhibitor BKM120 PO QD day on days 1-28 and cetuximab IV over 60-120 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.\n\nPI3K inhibitor BKM120: Given PO\n\ncetuximab: Given IV","id":"EG000","otherNumAffected":12,"otherNumAtRisk":12,"seriousNumAffected":4,"seriousNumAtRisk":12,"title":"Arm I (BKM120 PO and Cetuximab 500 mg IV 14 Days)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":12}],"term":"Hyperglycemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":12}],"term":"Hypomagnesemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":12}],"term":"Anorexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":12}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":12}],"term":"Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":12}],"term":"Hypoalbuminemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":12}],"term":"Rash"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":12}],"term":"ALT Increase"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":12}],"term":"AST increase"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":12}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":12}],"term":"Hypokalemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":12}],"term":"Anxiety"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":12}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":12}],"term":"Mood changes"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":12}],"term":"Mucositis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":12}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":12}],"term":"Pruritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":12}],"term":"Transaminitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":12}],"term":"Anemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":12}],"term":"Dysphagia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":12}],"term":"Increased BUN"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":12}],"term":"Leg tremor"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":12}],"term":"Total bilirubin increase"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":12}],"term":"Vomiting"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12}],"term":"Electrolyte abnormality and anemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":12}],"term":"Orthostatis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":12}],"term":"Acute Kidney Injury"}],"timeFrame":"4 years and 3 months"}