{"description":"All-Cause Mortality: Full Analysis Set consisted of all randomized participants.\n\nAdverse Events: Safety Analysis Set was defined consisted of all randomized participants who received at least 1 dose of axicabtagene ciloleucel or SOC chemotherapy. Safety Retreatment Analysis Set consisted of participants retreated with axicabtagene ciloleucel.\n\nData for all-cause mortality and adverse events were reported separately for initial axicabtagene ciloleucel treatment and re-treatment.","eventGroups":[{"deathsNumAffected":81,"deathsNumAtRisk":180,"description":"Participants received cyclophosphamide 500 mg/m\\^2/day IV infusion and fludarabine 30 mg/m\\^2/day IV infusion conditioning chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\\^6 anti-CD19 CAR transduced autologous T cells/kg on Day 0.","id":"EG000","otherNumAffected":170,"otherNumAtRisk":170,"seriousNumAffected":96,"seriousNumAtRisk":170,"title":"Axicabtagene Ciloleucel Treatment"},{"deathsNumAffected":101,"deathsNumAtRisk":179,"description":"Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen:\n\n* R-ICE: rituximab 375mg/m\\^2 before chemotherapy, ifosfamide 5g/m\\^2 24 hours CI on Day 2 + mesna, carboplatin AUC 5 Day 2, maximum dose 800mg, etoposide 100mg/m\\^2/day on Days 1-3;\n* R-ESHAP: rituximab 375mg/m\\^2 Day 1, etoposide 40mg/m\\^2/day IV on Days 1-4, methylprednisolone 500mg/day IV on Days 1-4 or 5, cisplatin at 25mg/m\\^2/day CI Days 1-4, cytarabine 2g/m\\^2 on Day 5;\n* R-GDP: rituximab 375mg/m\\^2 Day 1 (or Day 8), gemcitabine 1g/m\\^2 on Days 1 and 8, dexamethasone 40mg on Days 1-4, cisplatin 75mg/m\\^2 Day 1 or carboplatin AUC=5; or\n* R-DHAP: rituximab 375mg/m\\^2 before chemotherapy, dexamethasone 40mg/day on Days 1-4, high dose cytarabine 2g/m\\^2 every 12 hours for 2 doses on Day 2 following platinum, cisplatin 100mg/m\\^2 24 hours CI on Day 1 or oxaliplatin 100mg/m\\^2.\n\nParticipants who responded to second-line chemotherapy got high dose therapy and autologous stem cell transplant.","id":"EG001","otherNumAffected":166,"otherNumAtRisk":168,"seriousNumAffected":78,"seriousNumAtRisk":168,"title":"Standard of Care 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27.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":170},{"groupId":"EG001","numAffected":10,"numAtRisk":168},{"groupId":"EG002","numAffected":0,"numAtRisk":10}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":170},{"groupId":"EG001","numAffected":11,"numAtRisk":168},{"groupId":"EG002","numAffected":0,"numAtRisk":10}],"term":"Tinnitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":170},{"groupId":"EG001","numAffected":11,"numAtRisk":168},{"groupId":"EG002","numAffected":0,"numAtRisk":10}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":170},{"groupId":"EG001","numAffected":23,"numAtRisk":168},{"groupId":"EG002","numAffected":1,"numAtRisk":10}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":170},{"groupId":"EG001","numAffected":58,"numAtRisk":168},{"groupId":"EG002","numAffected":3,"numAtRisk":10}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":71,"numAtRisk":170},{"groupId":"EG001","numAffected":66,"numAtRisk":168},{"groupId":"EG002","numAffected":2,"numAtRisk":10}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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27.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":170},{"groupId":"EG001","numAffected":9,"numAtRisk":168},{"groupId":"EG002","numAffected":1,"numAtRisk":10}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170},{"groupId":"EG001","numAffected":15,"numAtRisk":168},{"groupId":"EG002","numAffected":0,"numAtRisk":10}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":170},{"groupId":"EG001","numAffected":28,"numAtRisk":168},{"groupId":"EG002","numAffected":0,"numAtRisk":10}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":170},{"groupId":"EG001","numAffected":1,"numAtRisk":168},{"groupId":"EG002","numAffected":1,"numAtRisk":10}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":149,"numAtRisk":170},{"groupId":"EG001","numAffected":40,"numAtRisk":168},{"groupId":"EG002","numAffected":9,"numAtRisk":10}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":170},{"groupId":"EG001","numAffected":1,"numAtRisk":168},{"groupId":"EG002","numAffected":0,"numAtRisk":10}],"term":"Hypertransaminasaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":170},{"groupId":"EG001","numAffected":1,"numAtRisk":168},{"groupId":"EG002","numAffected":0,"numAtRisk":10}],"term":"Hypogammaglobulinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":170},{"groupId":"EG001","numAffected":0,"numAtRisk":168},{"groupId":"EG002","numAffected":1,"numAtRisk":10}],"term":"Furuncle"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":170},{"groupId":"EG001","numAffected":5,"numAtRisk":168},{"groupId":"EG002","numAffected":0,"numAtRisk":10}],"term":"Oral candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":170},{"groupId":"EG001","numAffected":5,"numAtRisk":168},{"groupId":"EG002","numAffected":1,"numAtRisk":10}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":170},{"groupId":"EG001","numAffected":0,"numAtRisk":168},{"groupId":"EG002","numAffected":1,"numAtRisk":10}],"term":"Pseudomonas infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":170},{"groupId":"EG001","numAffected":5,"numAtRisk":168},{"groupId":"EG002","numAffected":0,"numAtRisk":10}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":170},{"groupId":"EG001","numAffected":12,"numAtRisk":168},{"groupId":"EG002","numAffected":0,"numAtRisk":10}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":170},{"groupId":"EG001","numAffected":16,"numAtRisk":168},{"groupId":"EG002","numAffected":2,"numAtRisk":10}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":170},{"groupId":"EG001","numAffected":15,"numAtRisk":168},{"groupId":"EG002","numAffected":1,"numAtRisk":10}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":170},{"groupId":"EG001","numAffected":14,"numAtRisk":168},{"groupId":"EG002","numAffected":0,"numAtRisk":10}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":170},{"groupId":"EG001","numAffected":2,"numAtRisk":168},{"groupId":"EG002","numAffected":1,"numAtRisk":10}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":170},{"groupId":"EG001","numAffected":15,"numAtRisk":168},{"groupId":"EG002","numAffected":0,"numAtRisk":10}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":170},{"groupId":"EG001","numAffected":4,"numAtRisk":168},{"groupId":"EG002","numAffected":0,"numAtRisk":10}],"term":"C-reactive protein increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":170},{"groupId":"EG001","numAffected":21,"numAtRisk":168},{"groupId":"EG002","numAffected":3,"numAtRisk":10}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":51,"numAtRisk":170},{"groupId":"EG001","numAffected":45,"numAtRisk":168},{"groupId":"EG002","numAffected":5,"numAtRisk":10}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":170},{"groupId":"EG001","numAffected":64,"numAtRisk":168},{"groupId":"EG002","numAffected":1,"numAtRisk":10}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":170},{"groupId":"EG001","numAffected":0,"numAtRisk":168},{"groupId":"EG002","numAffected":0,"numAtRisk":10}],"term":"Serum ferritin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 27.1","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":170},{"groupId":"EG001","numAffected":6,"numAtRisk":168},{"groupId":"EG002","numAffected":1,"numAtRisk":10}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 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