{"eventGroups":[{"deathsNumAffected":3,"deathsNumAtRisk":51,"description":"Standard of Care Stem cell collection without in-vivo purging with Bortezomib. Standard of Care drugs Granulocyte colony-stimulating factor (G-CSF) +/- Mozobil (the latter if needed).\n\nNOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B\n\nGranulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed.\n\nMozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator.","id":"EG000","otherNumAffected":39,"otherNumAtRisk":51,"seriousNumAffected":12,"seriousNumAtRisk":51,"title":"Stem Cell Collection Without In-vivo Purging With Bortezomib"},{"deathsNumAffected":1,"deathsNumAtRisk":50,"description":"Bortezomib will be given subcutaneously (SQ) at 1.3 mg/m2 on day -11 and day -8 followed by Granulocyte colony-stimulating factor (G-CSF) given SQ on day -4 thru day -1 and continued until the collection is completed. Mozobil will be given if needed.\n\nThere must be at least 72 hours between each dose of bortezomib. NOTE: Multiparametric Flow Cytometry to be performed on samples for BOTH groups A and B\n\nBortezomib: Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection.\n\nGranulocyte colony-stimulating factor (G-CSF): Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed.\n\nMozobil: Mozobil will be given to all participants by injection under the skin only if needed per Investigator.","id":"EG001","otherNumAffected":39,"otherNumAtRisk":50,"seriousNumAffected":24,"seriousNumAtRisk":50,"title":"Stem Cell Collection With In-vivo Purging With Bortezomib"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":51,"numEvents":26},{"groupId":"EG001","numAffected":7,"numAtRisk":50,"numEvents":8}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":51,"numEvents":34},{"groupId":"EG001","numAffected":27,"numAtRisk":50,"numEvents":33}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":51,"numEvents":11},{"groupId":"EG001","numAffected":9,"numAtRisk":50,"numEvents":10}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":51,"numEvents":11},{"groupId":"EG001","numAffected":8,"numAtRisk":50,"numEvents":10}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":51,"numEvents":10},{"groupId":"EG001","numAffected":6,"numAtRisk":50,"numEvents":7}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":51,"numEvents":16},{"groupId":"EG001","numAffected":14,"numAtRisk":50,"numEvents":14}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":51,"numEvents":55},{"groupId":"EG001","numAffected":29,"numAtRisk":50,"numEvents":45}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":51,"numEvents":12},{"groupId":"EG001","numAffected":6,"numAtRisk":50,"numEvents":7}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":51,"numEvents":14},{"groupId":"EG001","numAffected":10,"numAtRisk":50,"numEvents":11}],"term":"Edema limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":51,"numEvents":32},{"groupId":"EG001","numAffected":21,"numAtRisk":50,"numEvents":30}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":51,"numEvents":12},{"groupId":"EG001","numAffected":15,"numAtRisk":50,"numEvents":16}],"term":"Generalized muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":51,"numEvents":14},{"groupId":"EG001","numAffected":4,"numAtRisk":50,"numEvents":4}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":51,"numEvents":53},{"groupId":"EG001","numAffected":19,"numAtRisk":50,"numEvents":43}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":51,"numEvents":16},{"groupId":"EG001","numAffected":7,"numAtRisk":50,"numEvents":13}],"term":"Hypomagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":51,"numEvents":16},{"groupId":"EG001","numAffected":7,"numAtRisk":50,"numEvents":9}],"term":"Hyponatremia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":51,"numEvents":15},{"groupId":"EG001","numAffected":4,"numAtRisk":50,"numEvents":4}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":51,"numEvents":27},{"groupId":"EG001","numAffected":18,"numAtRisk":50,"numEvents":28}],"term":"Mucositis oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":51,"numEvents":59},{"groupId":"EG001","numAffected":29,"numAtRisk":50,"numEvents":45}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":51,"numEvents":37},{"groupId":"EG001","numAffected":16,"numAtRisk":50,"numEvents":24}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":51,"numEvents":68},{"groupId":"EG001","numAffected":18,"numAtRisk":50,"numEvents":24}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":51,"numEvents":37},{"groupId":"EG001","numAffected":21,"numAtRisk":50,"numEvents":27}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":51,"numEvents":46},{"groupId":"EG001","numAffected":23,"numAtRisk":50,"numEvents":46}],"term":"White blood cell decreased"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":51,"numEvents":8},{"groupId":"EG001","numAffected":7,"numAtRisk":50,"numEvents":7}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":50,"numEvents":2}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":50,"numEvents":1}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":50,"numEvents":0}],"term":"Enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":51,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":50,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":50,"numEvents":1}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":50,"numEvents":1}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":50,"numEvents":1}],"term":"Fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":50,"numEvents":2}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":50,"numEvents":1}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":50,"numEvents":4}],"term":"Mucositis oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":50,"numEvents":1}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":50,"numEvents":1}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":51,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":50,"numEvents":2}],"term":"Syncope"}],"timeFrame":"From the time of signing the consent until 30 days after collection or up to 2 months."}