{"eventGroups":[{"deathsNumAffected":4,"deathsNumAtRisk":98,"description":"Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance\n\nLenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.","id":"EG000","otherNumAffected":0,"otherNumAtRisk":98,"seriousNumAffected":6,"seriousNumAtRisk":98,"title":"Tandem Auto Transplant"},{"deathsNumAffected":4,"deathsNumAtRisk":86,"description":"Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance\n\nLenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.","id":"EG001","otherNumAffected":0,"otherNumAtRisk":86,"seriousNumAffected":10,"seriousNumAtRisk":86,"title":"RVD Consolidation"},{"deathsNumAffected":2,"deathsNumAtRisk":89,"description":"Initial autologous transplant followed by lenalidomide maintenance\n\nLenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.","id":"EG002","otherNumAffected":0,"otherNumAtRisk":89,"seriousNumAffected":6,"seriousNumAtRisk":89,"title":"Lenalidomide Maintenance"}],"frequencyThreshold":"5","seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":86,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":89,"numEvents":1}],"term":"Atrial fibrillation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":86,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":89,"numEvents":0}],"term":"Supraventricular tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":86,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":89,"numEvents":2}],"term":"Small intestinal obstruction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":86,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":89,"numEvents":1}],"term":"Cholecystitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":89,"numEvents":0}],"term":"Cervical vertebral fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":89,"numEvents":1}],"term":"Subdural haematoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":89,"numEvents":0}],"term":"Liver function test increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":89,"numEvents":0}],"term":"Acute lymphocytic leukaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":86,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":89,"numEvents":0}],"term":"Acute promyelocytic leukaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":86,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":89,"numEvents":1}],"term":"B precursor type acute leukaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":86,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":89,"numEvents":1}],"term":"B-cell type acute leukaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":89,"numEvents":0}],"term":"Breast cancer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":89,"numEvents":0}],"term":"Colon cancer metastatic"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":89,"numEvents":1}],"term":"Hodgkin's disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":86,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":89,"numEvents":0}],"term":"Invasive lobular breast carcinoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":89,"numEvents":0}],"term":"Malignant melanoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":89,"numEvents":0}],"term":"Myelodysplastic syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":86,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":89,"numEvents":0}],"term":"Oesophageal adenocarcinoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":89,"numEvents":0}],"term":"Renal cancer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":89,"numEvents":0}],"term":"Renal cell carcinoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":89,"numEvents":0}],"term":"Dizziness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":86,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":89,"numEvents":0}],"term":"Syncope"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":98,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":86,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":89,"numEvents":1}],"term":"Hypoxia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":86,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":89,"numEvents":0}],"term":"Deep vein thrombosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 20.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":98,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":86,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":89,"numEvents":0}],"term":"Hypotension"}],"timeFrame":"22 months post-enrollment to BMT CTN 07LT"}