{"description":"Adverse event (AE) reporting was done using the BMT CTN's Manual of Procedures (MOP). Unexpected, grade 3-5 AE were reported through an expedited AE reporting system. Expected AEs were reported using National Cancer Institute (NCI)'s Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 at regular intervals as defined on the Form Submission Schedule and reported in the secondary outcome \"Toxicities\". All fatal (Grade 5) expected adverse events were reported in an expedited manner.","eventGroups":[{"deathsNumAffected":1,"deathsNumAtRisk":21,"description":"Allogeneic HSCT and Fludarabine/Melphalan/Bortezomib conditioning followed by Ixazomib maintenance\n\nAllogeneic HSCT: Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For GVHD prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11.\n\nFludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3.\n\nMelphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3.\n\nBortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3.\n\nIxazomib: Between 60 and 120 days following HSCT, patients randomized to the experimental arm will receive Ixazomib maintenance. Maintenance will begin at 3-mg oral doses on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule, following successful completion of 3 cycles at the previous dosage, for a total of 12 cycles.","id":"EG000","otherNumAffected":4,"otherNumAtRisk":21,"seriousNumAffected":11,"seriousNumAtRisk":21,"title":"Ixazomib Maintenance"},{"deathsNumAffected":3,"deathsNumAtRisk":22,"description":"Allogeneic HSCT and Fludarabine/Melphalan/Bortezomib conditioning followed by placebo maintenance.\n\nAllogeneic HSCT: Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For GVHD prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11.\n\nFludarabine: Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3.\n\nMelphalan: Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3.\n\nBortezomib: Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3.\n\nPlacebo: Between 60 and 120 days following HSCT, patients randomized to the control group will be given 3 mg of placebo orally on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule following successful completion of 3 cycles of placebo maintenance at the 3-mg dose. This will continue for a total of 12 cycles.","id":"EG001","otherNumAffected":7,"otherNumAtRisk":22,"seriousNumAffected":12,"seriousNumAtRisk":22,"title":"Placebo"},{"deathsNumAffected":5,"deathsNumAtRisk":14,"description":"Participants who enrolled in the study but were not randomized to treatment.","id":"EG002","otherNumAffected":2,"otherNumAtRisk":14,"seriousNumAffected":7,"seriousNumAtRisk":14,"title":"Enrolled Not Randomized"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Ileus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Influenza like illness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (20.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Pyrexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Graft versus host disease in gastrointestinal tract"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Upper respiratory tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Myalgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (20.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Posterior reversible encephalopathy syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (20.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Acute kidney injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (20.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Pulmonary fibrosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (20.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Deep vein thrombosis"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (20.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (20.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":21,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Febrile neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (20.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Haemolytic anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (20.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Thrombotic microangiopathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (20.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Atrial tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Pericarditis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (20.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Vision blurred"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Cryptitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":22,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (20.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Pancreatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (20.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Chest pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":21,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":22,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Graft versus host disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Bacteraemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Clostridium difficile colitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Clostridium difficile infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":22,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Diverticulitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Gastroenteritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Lung infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Osteomyelitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (22.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Pneumonia viral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Upper respiratory tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (20.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Fluid overload"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (20.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (21.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Plasma cell leukaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (20.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Mental status changes"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (20.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Acute kidney injury"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (21.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":22,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Nephrotic syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (20.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Superior vena cava syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (20.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":21,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":14,"numEvents":0}],"term":"Thrombosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 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encephalopathy syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (20.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Orthostatic hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (20.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Thrombocytopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Pneumonia parainfluenzae viral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":14,"numEvents":2}],"term":"Sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (20.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":21,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":22,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":14,"numEvents":1}],"term":"Septic Shock"}],"timeFrame":"2 years post-randomization"}