{"description":"CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT)","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":25,"description":"Patients receive SMAC mimetic LCL161 (1200 mg) PO QD on days 1, 8, 15, and 22. Patients lacking a minor response by end of course 2 or partial response by end of course 4 may also receive cyclophosphamide (500 mg) PO QD on days 1, 8, 15, and 22 at the discretion of the treating physician. Patients taking cyclophosphamide with less than a 25% interval reduction in paraprotein receive SMAC mimetic LCL161 on days 2, 9, 16, and 23. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.","id":"EG000","otherNumAffected":25,"otherNumAtRisk":25,"seriousNumAffected":11,"seriousNumAtRisk":25,"title":"Treatment (SMAC Mimetic LCL161 and Cyclophosphamide)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":25,"numEvents":133}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":25,"numEvents":16}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":25,"numEvents":45}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":25,"numEvents":46}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":2}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":25,"numEvents":71}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":25,"numEvents":45}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":25,"numEvents":11}],"term":"Edema limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":25,"numEvents":134}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":25,"numEvents":14}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2}],"term":"Cytokine release syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":25,"numEvents":70}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":25,"numEvents":3}],"term":"Lymphocyte count increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":25,"numEvents":38}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":25,"numEvents":77}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":25,"numEvents":43}],"term":"White blood cell decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":25,"numEvents":18}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":25,"numEvents":5}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":25,"numEvents":37}],"term":"Peripheral motor neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":25,"numEvents":106}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Presyncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Personality change"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":25,"numEvents":33}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":25,"numEvents":26}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":25,"numEvents":22}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":25,"numEvents":14}],"term":"Rash maculo-papular"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2}],"term":"Cytokine release syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":25,"numEvents":5}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":3}],"term":"Hyperglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Hyperuricemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":25,"numEvents":2}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Urticaria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 12","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":25,"numEvents":1}],"term":"Hypotension"}],"timeFrame":"From baseline up to 30 days after last dose of study treatment"}