{"description":"All patients who received at least one dose of LDE225 plus bortezomib.","eventGroups":[{"description":"Cohort 1 will receive LDE225 orally on a daily basis, at 400mg/m\\^2 every 21 days.\n\nBortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.","id":"EG000","otherNumAffected":6,"otherNumAtRisk":7,"seriousNumAffected":2,"seriousNumAtRisk":7,"title":"Cohort 1: LDE225 400mg/m^2"},{"description":"Cohort 2 will receive LDE225 orally on a daily basis, at 600 mg every 21 days. 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creatinine"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":7,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"NCI CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hyponatremia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"NCI CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"NCI CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Decreased creatinine clearance"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NCI CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":7,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"NCI CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":7,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"NCI CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":7,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NCI CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Injection site reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NCI CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Abdominal Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"NCI CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Anorexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NCI CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Chills"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"NCI CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Confusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"NCI CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Dysgeusia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"NCI CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Dyspnea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NCI CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Edema Limbs"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"NCI CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Fever"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"NCI CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Muscle weakness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NCI CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"NCI CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hyperkalemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"NCI CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hyperuricemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"NCI CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hypokalemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"NCI CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hypomagnesemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"NCI CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"NCI CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Insomnia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"NCI CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Cyst"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"NCI CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Restlessness"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events 4.03","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Viral Gastroenteritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE 4.03","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":0,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":0,"numEvents":0}],"term":"Sepsis"}],"timeFrame":"Treatment-emergent adverse events were collected on Days 1 and 8 of every 21-day cycle for up to 48 weeks (plus 30 days for end of treatment visit)."}