{"description":"Adverse events: For Phase 1 and Phase 2 (Cohorts 1 to 6): The Safety Analysis Set included all participants treated with any dose of axicabtagene ciloleucel; For retreatment groups: The Safety-Retreatment Analysis Set include all participants with re-treatment of axicabtagene ciloleucel. All-cause mortality: For Phase 1 and Phase 2 (Cohorts 1 to 6): All Enrolled Analysis Set included all enrolled participants; Retreatment groups,participants were included from Safety-Retreatment Analysis Set.","eventGroups":[{"deathsNumAffected":5,"deathsNumAtRisk":8,"description":"Participants with diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) received conditioning chemotherapy (fludarabine 30 mg/m\\^2 intravenously \\[IV\\] over 30 minutes and cyclophosphamide 500 mg/m\\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel chimeric antigen receptor (CAR) transduced autologous T cells administered IV at a target dose of 2 x 10\\^6 anti-CD19 CAR T cells/kg of body weight (BW) on Day 0.","id":"EG000","otherNumAffected":7,"otherNumAtRisk":7,"seriousNumAffected":5,"seriousNumAtRisk":7,"title":"Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy"},{"deathsNumAffected":49,"deathsNumAtRisk":81,"description":"Participants with refractory DLBCL received conditioning chemotherapy (fludarabine 30 mg/m\\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\\^6 anti-CD19 CAR T cells/kg of BW on Day 0.","id":"EG001","otherNumAffected":77,"otherNumAtRisk":77,"seriousNumAffected":40,"seriousNumAtRisk":77,"title":"Phase 2 (Pivotal Study): Cohort 1"},{"deathsNumAffected":13,"deathsNumAtRisk":30,"description":"Participants with refractory PMBCL or TFL received conditioning chemotherapy (fludarabine 30 mg/m\\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\\^6 anti-CD19 CAR T cells/kg of BW on Day 0.","id":"EG002","otherNumAffected":23,"otherNumAtRisk":24,"seriousNumAffected":14,"seriousNumAtRisk":24,"title":"Phase 2 (Pivotal Study): Cohort 2"},{"deathsNumAffected":23,"deathsNumAtRisk":42,"description":"Participants with relapsed or refractory transplant ineligible DLBCL, PMBCL, or TFL received conditioning chemotherapy (fludarabine 30 mg/m\\^2 IV over 30 minutes and cyclophosphamide 500 mg/m\\^2 IV over 60 minutes) on Days -5, -4, and -3; followed by a single infusion of axicabtagene ciloleucel CAR transduced autologous T cells administered IV at a target dose of 2 x 10\\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and tocilizumab (8 mg/kg IV over 1 hour (not to exceed 800 mg)) on Day 2).","id":"EG003","otherNumAffected":38,"otherNumAtRisk":38,"seriousNumAffected":26,"seriousNumAtRisk":38,"title":"Phase 2 (Safety Management Study): Cohort 3"},{"deathsNumAffected":20,"deathsNumAtRisk":46,"description":"Participants with r/r DLBCL, PMBCL ,TFL, or high-grade B-cell lymphoma (HGBCL) after 2 systemic lines of therapy received optional bridging therapy (dexamethasone 20mg to 40mg,either orally or IV daily for 1 to 4 days or 1g/m\\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\\^2 weekly for 3 weeks or bendamustine 90 mg/m\\^2 on Days 1 and 2 and rituximab 375mg/m\\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\\^2 IV and cyclophosphamide 500mg/m\\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\\^6 anti-CD19 CAR T cells/kg of BW. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).","id":"EG004","otherNumAffected":41,"otherNumAtRisk":41,"seriousNumAffected":24,"seriousNumAtRisk":41,"title":"Phase 2 (Safety Management Study): Cohort 4"},{"deathsNumAffected":37,"deathsNumAtRisk":58,"description":"Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy received debulking therapy (R-CHOP:rituximab 375mg/m\\^2 D1,doxorubicin 50mg/m\\^2 D1,prednisone 100mg D1 to D5,cyclophosphamide 750mg/m\\^2 D1,vincristine 1.4 mg/m\\^2 D1 or R-ICE:rituximab 375mg/ m\\^2 D1,ifosfamide 5g/m\\^2 24h-CI D2,carboplatin AUC5 D2 maximum dose 800mg,etoposide 100 mg/m\\^2/day D1 to D3 or R-GEMOX:rituximab 375mg/m\\^2 D1,gemcitabine 1000mg/m\\^2 D2,oxaliplatin 100mg/m\\^2 D2 or R-GDP:rituximab 375mg/m\\^2 D1 or D8,gemcitabine 1g/m\\^2 D1 \\& D8,dexamethasone 40mg D1 to D4,cisplatin 75mg/m\\^2 D1(or carboplatin AUC5 D1) or radiotherapy:20 to 30 Gy), conditioning chemotherapy (fludarabine 30mg/m\\^2 IV and cyclophosphamide 500mg/m\\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel at a target dose of 2 x 10\\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV BID starting on D0).D=Day.","id":"EG005","otherNumAffected":50,"otherNumAtRisk":50,"seriousNumAffected":27,"seriousNumAtRisk":50,"title":"Phase 2 (Safety Management Study): Cohort 5"},{"deathsNumAffected":20,"deathsNumAtRisk":42,"description":"Participants with r/r DLBCL, PMBCL ,TFL, or HGBCL after 2 systemic lines of therapy may have received bridging therapy (dexamethasone 20mg to 40mg, either orally or IV daily for 1 to 4 days or 1g/m\\^2 of high-dose methylprednisolone(HDMP) for 3 days with rituximab at 375mg/m\\^2 weekly for 3 weeks or bendamustine 90 mg/m\\^2 on Days 1 and 2 and rituximab 375mg/m\\^2 on Day 1), conditioning chemotherapy (fludarabine 30mg/m\\^2 IV and cyclophosphamide 500mg/m\\^2 IV)on Days -5,-4, and -3; followed by single infusion of axicabtagene ciloleucel CAR transduced autologous T cells IV at a target dose of 2 x 10\\^6 anti-CD19 CAR T cells/kg of BW on Day 0. Participants also received a prophylactic regimen of levetiracetam (750 mg orally or IV twice daily (BID) starting on Day 0) and corticosteroids (dexamethasone, 10 mg once daily on Days 0, 1, and 2). Participants received tocilizumab (initiated on persistent Grade 1 CRS for over 24 hours) and dexamethasone (persistent Grade 1 CRS for over 72 hours and at onset of Grade 1 neurologic toxicity).","id":"EG006","otherNumAffected":40,"otherNumAtRisk":40,"seriousNumAffected":25,"seriousNumAtRisk":40,"title":"Phase 2 (Safety Management Study): Cohort 6"},{"deathsNumAffected":1,"deathsNumAtRisk":1,"description":"Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the axicabtagene ciloleucel regimen selected for Phase 2.","id":"EG007","otherNumAffected":1,"otherNumAtRisk":1,"seriousNumAffected":1,"seriousNumAtRisk":1,"title":"Retreatment Axicabtagene Ciloleucel: Phase 1"},{"deathsNumAffected":8,"deathsNumAtRisk":9,"description":"Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.","id":"EG008","otherNumAffected":9,"otherNumAtRisk":9,"seriousNumAffected":5,"seriousNumAtRisk":9,"title":"Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 1"},{"deathsNumAffected":2,"deathsNumAtRisk":2,"description":"Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.","id":"EG009","otherNumAffected":2,"otherNumAtRisk":2,"seriousNumAffected":1,"seriousNumAtRisk":2,"title":"Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 2"},{"deathsNumAffected":1,"deathsNumAtRisk":2,"description":"Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.","id":"EG010","otherNumAffected":2,"otherNumAtRisk":2,"seriousNumAffected":2,"seriousNumAtRisk":2,"title":"Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 3"},{"deathsNumAffected":2,"deathsNumAtRisk":2,"description":"Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.","id":"EG011","otherNumAffected":2,"otherNumAtRisk":2,"seriousNumAffected":0,"seriousNumAtRisk":2,"title":"Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 4"},{"deathsNumAffected":2,"deathsNumAtRisk":2,"description":"Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.","id":"EG012","otherNumAffected":2,"otherNumAtRisk":2,"seriousNumAffected":0,"seriousNumAtRisk":2,"title":"Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 5"},{"deathsNumAffected":0,"deathsNumAtRisk":0,"description":"Participants who initially responded and subsequently relapsed, became eligible for second course of conditioning chemotherapy and axicabtagene ciloleucel. Participants received the same axicabtagene ciloleucel regimen as the original target dose.","id":"EG013","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"Retreatment Axicabtagene Ciloleucel: Phase 2 Cohort 6"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 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26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7},{"groupId":"EG001","numAffected":13,"numAtRisk":77},{"groupId":"EG002","numAffected":3,"numAtRisk":24},{"groupId":"EG003","numAffected":4,"numAtRisk":38},{"groupId":"EG004","numAffected":7,"numAtRisk":41},{"groupId":"EG005","numAffected":8,"numAtRisk":50},{"groupId":"EG006","numAffected":7,"numAtRisk":40},{"groupId":"EG007","numAffected":0,"numAtRisk":1},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":2},{"groupId":"EG010","numAffected":0,"numAtRisk":2},{"groupId":"EG011","numAffected":0,"numAtRisk":2},{"groupId":"EG012","numAffected":0,"numAtRisk":2},{"groupId":"EG013","numAffected":0,"numAtRisk":0}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7},{"groupId":"EG001","numAffected":5,"numAtRisk":77},{"groupId":"EG002","numAffected":0,"numAtRisk":24},{"groupId":"EG003","numAffected":0,"numAtRisk":38},{"groupId":"EG004","numAffected":3,"numAtRisk":41},{"groupId":"EG005","numAffected":0,"numAtRisk":50},{"groupId":"EG006","numAffected":4,"numAtRisk":40},{"groupId":"EG007","numAffected":0,"numAtRisk":1},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":2},{"groupId":"EG010","numAffected":0,"numAtRisk":2},{"groupId":"EG011","numAffected":0,"numAtRisk":2},{"groupId":"EG012","numAffected":0,"numAtRisk":2},{"groupId":"EG013","numAffected":0,"numAtRisk":0}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":7},{"groupId":"EG001","numAffected":26,"numAtRisk":77},{"groupId":"EG002","numAffected":12,"numAtRisk":24},{"groupId":"EG003","numAffected":18,"numAtRisk":38},{"groupId":"EG004","numAffected":16,"numAtRisk":41},{"groupId":"EG005","numAffected":16,"numAtRisk":50},{"groupId":"EG006","numAffected":20,"numAtRisk":40},{"groupId":"EG007","numAffected":0,"numAtRisk":1},{"groupId":"EG008","numAffected":1,"numAtRisk":9},{"groupId":"EG009","numAffected":1,"numAtRisk":2},{"groupId":"EG010","numAffected":0,"numAtRisk":2},{"groupId":"EG011","numAffected":0,"numAtRisk":2},{"groupId":"EG012","numAffected":0,"numAtRisk":2},{"groupId":"EG013","numAffected":0,"numAtRisk":0}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 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26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7},{"groupId":"EG001","numAffected":24,"numAtRisk":77},{"groupId":"EG002","numAffected":6,"numAtRisk":24},{"groupId":"EG003","numAffected":12,"numAtRisk":38},{"groupId":"EG004","numAffected":7,"numAtRisk":41},{"groupId":"EG005","numAffected":9,"numAtRisk":50},{"groupId":"EG006","numAffected":10,"numAtRisk":40},{"groupId":"EG007","numAffected":0,"numAtRisk":1},{"groupId":"EG008","numAffected":0,"numAtRisk":9},{"groupId":"EG009","numAffected":0,"numAtRisk":2},{"groupId":"EG010","numAffected":0,"numAtRisk":2},{"groupId":"EG011","numAffected":0,"numAtRisk":2},{"groupId":"EG012","numAffected":0,"numAtRisk":2},{"groupId":"EG013","numAffected":0,"numAtRisk":0}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 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