{"eventGroups":[{"deathsNumAffected":1,"deathsNumAtRisk":70,"description":"Patients receive activated Marrow Infiltrating Lymphocytes (aMIL)\n\naMIL: On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide.","id":"EG000","otherNumAffected":11,"otherNumAtRisk":70,"seriousNumAffected":64,"seriousNumAtRisk":70,"title":"aMIL Arm"},{"deathsNumAffected":1,"deathsNumAtRisk":31,"description":"Patients do not receive activated Marrow Infiltrating Lymphocytes (aMIL)\n\nNo aMIL: On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide.","id":"EG001","otherNumAffected":0,"otherNumAtRisk":31,"seriousNumAffected":29,"seriousNumAtRisk":31,"title":"No aMIL"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Product Issues","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0}],"term":"manufacture failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Product Issues","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0}],"term":"product contamination"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"63 participants in the aMILs Arm had infusions, of those, 8 had record of infusion reaction.","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":63,"numEvents":8},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0}],"term":"infusion related reaction"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher Adverse Events (AEs) from aMILs harvest to 60 days following autologous stem cell transplant (ASCT)","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":36,"numAtRisk":70,"numEvents":45},{"groupId":"EG001","numAffected":18,"numAtRisk":31,"numEvents":22}],"term":"Febrile neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":70,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Acute Kidney Injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":70,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0}],"term":"Anemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":2}],"term":"Atrial Fibrillation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":2}],"term":"Back Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0}],"term":"Pancytopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":70,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0}],"term":"Bone Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0}],"term":"Colitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0}],"term":"dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":70,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Device related infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":70,"numEvents":8},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":70,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Enterocolitis infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0}],"term":"Esophagitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"General disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":70,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"fever"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":70,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Gastric ulcer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0}],"term":"headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0}],"term":"hypocalcemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":70,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0}],"term":"hypophosphatemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0}],"term":"hypoxia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":70,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"bacteremia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":70,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Kidney infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"lung infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":2}],"term":"lymphocyte count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":70,"numEvents":11},{"groupId":"EG001","numAffected":5,"numAtRisk":31,"numEvents":5}],"term":"mucosal infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":3}],"term":"nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":70,"numEvents":10},{"groupId":"EG001","numAffected":3,"numAtRisk":31,"numEvents":4}],"term":"neutrophil count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":70,"numEvents":7},{"groupId":"EG001","numAffected":4,"numAtRisk":31,"numEvents":4}],"term":"platelet count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Renal and urinary disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":70,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"renal calculi"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0}],"term":"Scrotal Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0}],"term":"Sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":70,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Stroke"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Nervous system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"syncope"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Vascular disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"thromboembolic event"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Infections and infestations","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"upper respiratory infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Cardiac disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":70,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0}],"term":"ventricular arrhythmia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Grade 3 or higher AEs from aMILs harvest to 60 days following ASCT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":70,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"CTCAE (4.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":70,"numEvents":4},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"white blood cell decreased"}],"timeFrame":"60 Days from aMILs harvest until Day 60 after transplant"}