{"eventGroups":[{"deathsNumAffected":14,"deathsNumAtRisk":31,"description":"Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by stem cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).","id":"EG000","otherNumAffected":21,"otherNumAtRisk":31,"seriousNumAffected":7,"seriousNumAtRisk":31,"title":"Arm A: Low-dose Dexamethasone + Stem Cell Transplantation"},{"deathsNumAffected":11,"deathsNumAtRisk":28,"description":"Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses).\n\nOnly includes subjects who received drug.","id":"EG001","otherNumAffected":19,"otherNumAtRisk":28,"seriousNumAffected":7,"seriousNumAtRisk":28,"title":"Arm B: Low-dose Dexamethasone"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":12},{"groupId":"EG001","numAffected":4,"numAtRisk":28,"numEvents":14}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":7},{"groupId":"EG001","numAffected":5,"numAtRisk":28,"numEvents":11}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":31,"numEvents":22},{"groupId":"EG001","numAffected":4,"numAtRisk":28,"numEvents":7}],"term":"Decreased Neutrophil Count"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":31,"numEvents":13},{"groupId":"EG001","numAffected":3,"numAtRisk":28,"numEvents":7}],"term":"Decreased WBC Count"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":31,"numEvents":24},{"groupId":"EG001","numAffected":1,"numAtRisk":28,"numEvents":1}],"term":"Decreased Platelet Count"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":31,"numEvents":11},{"groupId":"EG001","numAffected":7,"numAtRisk":28,"numEvents":26}],"term":"Abnormal Neutrophils/Granulocytes (ANC/AGC)"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":28,"numEvents":6}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":6},{"groupId":"EG001","numAffected":2,"numAtRisk":28,"numEvents":3}],"term":"Increased Alanine Aminotransferase"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":7},{"groupId":"EG001","numAffected":3,"numAtRisk":28,"numEvents":3}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":4},{"groupId":"EG001","numAffected":5,"numAtRisk":28,"numEvents":7}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":5},{"groupId":"EG001","numAffected":5,"numAtRisk":28,"numEvents":7}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":28,"numEvents":8}],"term":"Abnormal Leukocytes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":4,"numAtRisk":28,"numEvents":12}],"term":"Abnormal Platelet Count"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":28,"numEvents":8}],"term":"Abnormal Hemoglobin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":28,"numEvents":3}],"term":"Upper Respiratory Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":28,"numEvents":1}],"term":"Urinary Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":28,"numEvents":5}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":28,"numEvents":4}],"term":"Paresthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":28,"numEvents":4}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":28,"numEvents":2}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":4},{"groupId":"EG001","numAffected":3,"numAtRisk":28,"numEvents":5}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":28,"numEvents":1}],"term":"Abdominal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":28,"numEvents":3}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":28,"numEvents":6}],"term":"Decreased Lymphocyte Count"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":28,"numEvents":4}],"term":"Musculoskeletal and Connective Tissue Disorder"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":28,"numEvents":1}],"term":"Presyncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":28,"numEvents":2}],"term":"Bone Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":28,"numEvents":0}],"term":"Febrile Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Anal/Perianal","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":28,"numEvents":1}],"term":"Infection with Grade 3 or 4 Neutrophils"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":28,"numEvents":1}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":28,"numEvents":0}],"term":"Lung Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":28,"numEvents":2}],"term":"Myelodysplastic Syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":28,"numEvents":0}],"term":"Neoplasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":28,"numEvents":0}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":28,"numEvents":1}],"term":"Pain of skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":28,"numEvents":1}],"term":"Abdominal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":28,"numEvents":1}],"term":"Back Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":28,"numEvents":0}],"term":"Skin Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":28,"numEvents":0}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":28,"numEvents":2}],"term":"Thromboembolic Event"}],"timeFrame":"3 years"}