{"description":"Arm D and Arm E did not enrolled any patients","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":20,"description":"VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11 in combination with high-dose cyclophosphamide at 2.0 g/m2 on day 4. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.\n\nbortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11\n\ncyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)\n\nG-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)","id":"EG000","otherNumAffected":8,"otherNumAtRisk":20,"seriousNumAffected":0,"seriousNumAtRisk":20,"title":"Arm A: VELCADE, CYCLOPHOSPHAMIDE, & G-CSF"},{"deathsNumAffected":0,"deathsNumAtRisk":4,"description":"VELCADE at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day. Day 12 start pheresis collection\n\nbortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11\n\nG-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)","id":"EG001","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":0,"seriousNumAtRisk":4,"title":"Arm B: VELCADE & G-CSF"},{"deathsNumAffected":0,"deathsNumAtRisk":23,"description":"High-dose cyclophosphamide at 2.0 g/m2 on day 1. G-CSF is given for ten (+/- two) consecutive days starting on day 2 at a dose of 10 micrograms/kg/day. Pheresis will commence once ANC of 1.5 is reached.\n\ncyclophosphamide: 2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)\n\nG-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)","id":"EG002","otherNumAffected":18,"otherNumAtRisk":23,"seriousNumAffected":1,"seriousNumAtRisk":23,"title":"Arm C: CYCLOPHOSPHAMIDE & G-CSF"},{"deathsNumAffected":0,"deathsNumAtRisk":0,"description":"G-CSF is given for ten (+/- two) consecutive days starting on day 1 at a dose of 10 micrograms/kg/day. Plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5. Both G-CSF and plerixafor are continued daily until collection is complete. Pheresis will commence for everyone on Day 5 regardless of ANC status.\n\nG-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)\n\nPlerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)","id":"EG003","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"Arm D: PLERIXAFOR & G-CSF"},{"deathsNumAffected":0,"deathsNumAtRisk":0,"description":"Bortezomib at 1.3 mg/m2 IVP on days 1, 4, 8 and 11. G-CSF is given for ten (+/- wo) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day.\n\nPlerixafor is given on day 12, approximately 11 hours prior to stem cell collection attempt and is continued daily until collection is complete. Pheresis will commence for everyone on Day 13 regardless of ANC status.\n\nbortezomib (Velcade): 1.3 mg/m2 IVP on days 1, 4, 8 and 11\n\nG-CSF: given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)\n\nPlerixafor: plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)","id":"EG004","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"Arm E: PLERIXAFOR, VELCADE, & G-CSF"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":4},{"groupId":"EG002","numAffected":2,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Hypocalcemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":4},{"groupId":"EG002","numAffected":8,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":4},{"groupId":"EG002","numAffected":5,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Anemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":20},{"groupId":"EG001","numAffected":4,"numAtRisk":4},{"groupId":"EG002","numAffected":11,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":2,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":4},{"groupId":"EG002","numAffected":7,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"hypoglycemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":2,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":6,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":2,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Hypokalemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":3,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Hypomagnesemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Gallbladder Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Dyspnea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":2,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Generalized muscle weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":4,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Serum creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":2,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"INR increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":2,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Flu like symptoms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Upper respiratory infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Gastroesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Gingival pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Edema limbs"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":2,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"bloating"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Vulval infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Chest wall pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Papulopustular rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Anorexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue 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disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Skin ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Thrombotic thrombocytopenic purpura"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Other, Eye twitch"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"bruising; extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Mucosal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Injection Site Reaction"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":20},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":23},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":0}],"term":"Febrile Neutropenia"}],"timeFrame":"Patients who do not withdraw consent will be followed for survival after end of treatment on a monthly to bi-monthly basis or until death, whichever occurs first. Patients removed from study for unacceptable adverse events will be followed for life every 6 months, unless they withdraw consent."}