Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2026-01-05 @ 5:49 PM
Study NCT ID:
NCT03391466
Status:
COMPLETED
Last Update Posted:
2025-12-01
First Post:
2017-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629083', 'term': 'axicabtagene ciloleucel'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'C024352', 'term': 'fludarabine'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@kitepharma.com', 'phone': '844-454-5483 (1-844-454-KITE)', 'title': 'Medical Information', 'organization': 'Kite, A Gilead Company'}, 'certainAgreement': {'otherDetails': 'After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:\n\n* The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or\n* The study has been completed at all study sites for at least 2 years', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality and Adverse events: Up to 74.9 months', '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': [{'id': 'EG000', 'title': 'Axicabtagene Ciloleucel Treatment', '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.', 'otherNumAtRisk': 170, 'deathsNumAtRisk': 180, 'otherNumAffected': 170, 'seriousNumAtRisk': 170, 'deathsNumAffected': 81, 'seriousNumAffected': 96}, {'id': 'EG001', 'title': 'Standard of Care Therapy', '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.', 'otherNumAtRisk': 168, 'deathsNumAtRisk': 179, 'otherNumAffected': 166, 'seriousNumAtRisk': 168, 'deathsNumAffected': 101, 'seriousNumAffected': 78}, {'id': 'EG002', 'title': 'Retreatment Axicabtagene Ciloleucel', 'description': 'Participants who achieved a partial response or complete response and subsequently experienced disease progression received a second course of conditioning chemotherapy (cyclophosphamide 500 mg/m\\^2/day IV infusion and fludarabine 30 mg/m\\^2/day IV infusion) for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\\^6 anti-CD 19 CAR transduced autologous T cells/kg.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'deathsNumAffected': 3, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 90}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 58}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 71}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 66}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 116}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 55}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 87}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 149}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypertransaminasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypogammaglobulinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pseudomonas infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 64}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Serum ferritin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 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'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Bradyphrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Faecaluria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Lung opacity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Tachypnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Haematopoietic stem cell mobilisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Angiopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Event Free Survival (EFS) Per Blinded Central Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axicabtagene Ciloleucel', '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': 'OG001', 'title': 'Standard of Care Therapy', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '15.8'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '2.8'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.398', 'ciLowerLimit': '0.308', 'ciUpperLimit': '0.514', 'pValueComment': 'Stratified (randomization factors) log-rank p-value.', 'estimateComment': 'Hazard ratio (95% confidence interval (CI)), stratified using randomization stratification factors.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified (randomization stratification factors) log-rank test.', 'nonInferiorityComment': 'One-sided p-value based on log-rank test stratified by response to first-line therapy and second-line age-adjusted International Prognostic Index (IPI) as data collected on case report forms.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization date up to a median follow-up: 24.9 months', 'description': 'EFS:Time from randomization to disease progression (PD), best response of stable disease (SD) up to Day 150, start of new anti-lymphoma therapy including stem cell transplant, or death from any cause. PD=Score 4 (uptake moderately \\> liver) or 5 (uptake markedly \\> liver and/or new lesions) with increased uptake from baseline; New fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma rather than another etiology or in bone marrow; Individual node/lesion abnormal with longest diameter \\> 1.5 cm, ≥ 50% increase from nadir; Splenic length increase \\> 50% of prior increase beyond baseline or ≥ 2 cm increase if no prior splenomegaly; New/recurrent splenomegaly, progression of non-measurable lesions, new lesion, or new/recurrent bone marrow involvement. KM estimates was used for analysis.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR) Per Blinded Central Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axicabtagene Ciloleucel', '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': 'OG001', 'title': 'Standard of Care Therapy', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000', 'lowerLimit': '77.1', 'upperLimit': '88.5'}, {'value': '50', 'groupId': 'OG001', 'lowerLimit': '42.7', 'upperLimit': '57.8'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in ORR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.1', 'ciLowerLimit': '23.2', 'ciUpperLimit': '42.1', 'pValueComment': 'Stratified (randomization factor) CMH test p-value.', 'estimateComment': "95% CI for the difference in ORR was from Wilson's score method with continuity correction.", 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified (randomization factor) CMH test.', 'nonInferiorityComment': 'One-sided p-value based on Cochran-Mantel-Haenszel (CMH) test, one-sided tailed test, stratified by response to first-line therapy and second-line age-adjusted International Prognostic Index (IPI) as data collected on case report forms.'}], 'paramType': 'NUMBER', 'timeFrame': 'From randomization date up to a median follow-up: 24.9 months', 'description': 'ORR: Percentage of participants with CR (Complete Metabolic Response (CMR);Complete Radiologic Response (CRR)) or PR (partial metabolic response (PMR); partial radiologic response (PRR)).CMR: Positron emission tomography (PET) 5-point scale scores: 1-No uptake above background; 2-Uptake ≤mediastinum; 3-Uptake \\>mediastinum but ≤liver, with/without residual mass; no new lesions, no FDG-avid disease in bone marrow. CRR: Target nodes/nodal masses regressed ≤1.5 cm in longest diameter, no extralymphatic sites, no non-measured lesions, normal organ size, no new sites, normal bone marrow morphology. PMR: Scores 4 (uptake moderately \\>liver), 5 (uptake markedly \\>liver, new lesions) with reduced uptake from baseline and residual mass, no new lesions. Responding at interim/residual disease at end of treatment. PRR: ≥50% decrease in sum of diameters of up to 6 target measurable lesions, no increase in non-measured lesions, spleen length decreased \\>50% if previously enlarged, no new lesion sites.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axicabtagene Ciloleucel', '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': 'OG001', 'title': 'Standard of Care Therapy', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and upper limit of CI were not reached due to insufficient number of events.', 'groupId': 'OG000', 'lowerLimit': '28.3', 'upperLimit': 'NA'}, {'value': '35.1', 'comment': 'Upper limit of CI was not reached due to insufficient number of events.', 'groupId': 'OG001', 'lowerLimit': '18.5', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.027', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.730', 'ciLowerLimit': '0.530', 'ciUpperLimit': '1.007', 'pValueComment': 'Stratified log-rank (randomization factor) p-value.', 'estimateComment': 'Stratified Cox regression models were used to estimate hazard ratio and 2-sided CIs for axicabtagene ciloleucel relative to standard of care therapy. The Breslow method was used to handle the ties for the Cox regression models.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified (randomization factor) log-rank test.', 'nonInferiorityComment': 'One-sided p-value based on log-rank test stratified by response to first-line therapy and second-line age-adjusted IPI as data collected on case report forms.', 'otherAnalysisDescription': 'The Rho family spending function with parameter (Rho = 6) was used to allocate alpha between the interim and primary OS analysis. Given that fewer than the anticipated 210 events were observed at the data cutoff date for the primary OS analysis (25 January 2023), the efficacy boundary for the primary OS analysis was recalculated using the Rho family spending function based on the actual observed event numbers (177 deaths) resulting in an efficacy boundary at 1-sided significance level of 0.0249.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 74.9 months', 'description': 'Overall survival is defined as the time from randomization to death from any cause. Kaplan-Meier (KM) estimates were used for analysis.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DOR) Per Blinded Central Assessments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axicabtagene Ciloleucel', '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': 'OG001', 'title': 'Standard of Care Therapy', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.9', 'comment': 'Upper limit of CI was not reached due to insufficient number of events.', 'groupId': 'OG000', 'lowerLimit': '13.6', 'upperLimit': 'NA'}, {'value': '8.9', 'comment': 'Upper limit of CI was not reached due to insufficient number of events.', 'groupId': 'OG001', 'lowerLimit': '5.7', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.0695', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.736', 'ciLowerLimit': '0.488', 'ciUpperLimit': '1.108', 'pValueComment': 'Stratified (randomization stratification factors) log-rank test.', 'estimateComment': 'Stratified Cox regression models were used to estimate hazard ratio and 2-sided 95% CIs for axicabtagene ciloleucel relative to standard of care.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'One-sided p-value based on log-rank test stratified by response to first-line therapy and second-line age-adjusted IPI as data collected on case report forms.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of first confirmed objective response (CR or PR) to disease progression or death regardless of cause (Up to 37.8 months)', 'description': 'DOR was defined only for participants who experience an objective response after axicabtagene ciloleucel infusion and was the time from the first objective response per Lugano classification to disease progression or death from any cause. Objective response was defined in outcome measure 2 and disease progression was defined in outcome measure 1. KM estimates were used for analysis.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set with objective response were analyzed. Participants not meeting the criteria by the analysis data cut-off date were censored at their last evaluable disease assessment date prior to the data cut-off date or new lymphoma therapy start date (including stem cell transplant in the axicabtagene ciloleucel arm or retreatment of axicabtagene ciloleucel), whichever was earlier.'}, {'type': 'SECONDARY', 'title': 'Modified Event Free Survival (mEFS) Per Blinded Central Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axicabtagene Ciloleucel', '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': 'OG001', 'title': 'Standard of Care Therapy', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '21.5'}, {'value': '2.0', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '2.8'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.376', 'ciLowerLimit': '0.290', 'ciUpperLimit': '0.487', 'pValueComment': 'One-sided p-value based on log-rank test stratified by response to first-line therapy and second-line age-adjusted IPI as data collected on case report forms.', 'estimateComment': 'Stratified Cox regression models were used to estimate hazard ratio and 2-sided 95% CIs for axicabtagene ciloleucel relative to standard of care therapy. The Breslow method was used to handle the ties for the Cox regression models.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified (randomization stratification factors) log-rank test.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization date up to a median follow-up: 24.9 months', 'description': 'Modified event free survival is defined the same way as EFS, except that a best response of SD up to and including Day 150 assessment post randomization was not considered an event. KM estimates were used for analysis.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'EFS Per Investigator Disease Assessments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axicabtagene Ciloleucel', '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': 'OG001', 'title': 'Standard of Care Therapy', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '25.5'}, {'value': '2.3', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '3.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.422', 'ciLowerLimit': '0.327', 'ciUpperLimit': '0.545', 'estimateComment': 'Stratified Cox regression models were used to estimate hazard ratio and 2-sided 95% CIs for axicabtagene ciloleucel relative to standard of care therapy. The Breslow method was used to handle the ties for the Cox regression models.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization date up to a median follow-up: 47.2 months', 'description': 'EFS was defined as the time from randomization to the earliest date of disease progression per the Lugano Classification, best response of stable disease (SD) up to and including Day 150, commencement of new lymphoma therapy, or death from any cause. Disease progression is defined in outcome measure 1.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Progression-Free Survival (PFS) Per Investigator Disease Assessments', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axicabtagene Ciloleucel', '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': 'OG001', 'title': 'Standard of Care Therapy', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000', 'lowerLimit': '5.4', 'upperLimit': '43.5'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '5.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.506', 'ciLowerLimit': '0.383', 'ciUpperLimit': '0.669', 'estimateComment': 'Stratified Cox regression models were used to estimate hazard ratio and 2-sided 95% CIs for axicabtagene ciloleucel relative to standard of care therapy. The Breslow method was used to handle the ties for the Cox regression models.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization date up to a median follow-up: 47.2 months', 'description': 'PFS is defined as the time from the randomization date to the date of disease progression per Lugano classification or death from any cause. Disease progression is defined in outcome measure 1. KM estimates were used for analysis.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Modified Event Free Survival (mEFS) Per Investigator Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axicabtagene Ciloleucel', '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': 'OG001', 'title': 'Standard of Care Therapy', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '29.1'}, {'value': '2.3', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '3.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.412', 'ciLowerLimit': '0.318', 'ciUpperLimit': '0.532', 'estimateComment': 'Stratified Cox regression models were used to estimate hazard ratio and 2-sided 95% CIs for axicabtagene ciloleucel relative to standard of care therapy. The Breslow method was used to handle the ties for the Cox regression models.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomization date up to a median follow-up: 47.2 months', 'description': 'mEFS is defined the same way as EFS, except that a best response of SD up to and including Day 150 assessment post randomization was not considered an event. KM estimates were used for analysis.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Full Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Global Health Status Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axicabtagene Ciloleucel', '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': 'OG001', 'title': 'Standard of Care Therapy', '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.'}], 'classes': [{'title': 'Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.6', 'spread': '19.9', 'groupId': 'OG000'}, {'value': '70.1', 'spread': '23.1', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Day 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.4', 'spread': '20.2', 'groupId': 'OG000'}, {'value': '-8.5', 'spread': '22.7', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Day 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '19.6', 'groupId': 'OG000'}, {'value': '-15.3', 'spread': '22.7', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Day 150', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.9', 'spread': '24.9', 'groupId': 'OG000'}, {'value': '-4.2', 'spread': '23.7', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.0', 'spread': '22.7', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '23.7', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.6', 'spread': '24.9', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '20.2', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.0', 'spread': '22.3', 'groupId': 'OG000'}, {'value': '9.9', 'spread': '18.9', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.2', 'spread': '20.9', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '21.3', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.0', 'spread': '21.5', 'groupId': 'OG000'}, {'value': '15.0', 'spread': '19.6', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.6', 'spread': '21.0', 'groupId': 'OG000'}, {'value': '13.2', 'spread': '17.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mixed Model with Repeated Measures', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.1', 'ciLowerLimit': '12.3', 'ciUpperLimit': '23.9', 'pValueComment': 'False Discovery Rate Methodology', 'groupDescription': 'Difference in mean change of scores from Baseline at Day 100.', 'statisticalMethod': 'Mixed Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0124', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mixed Model with Repeated Measures', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.8', 'ciLowerLimit': '2.6', 'ciUpperLimit': '17.0', 'pValueComment': 'False Discovery Rate Methodology', 'groupDescription': 'Difference in mean change of scores from Baseline at Day 150.', 'statisticalMethod': 'Mixed Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2655', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mixed Model with Repeated Measures', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.4', 'ciLowerLimit': '-3.3', 'ciUpperLimit': '12.0', 'pValueComment': 'False Discovery Rate Methodology', 'groupDescription': 'Difference in mean change of scores from Baseline at Month 9.', 'statisticalMethod': 'Mixed Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 50, 100, and 150; Months 9, 12, 15, 18, 21 and 24', 'description': 'Global health status was measured using European Organization for Research and Treatment of Cancer (EORTC) Quality Life Questionnaire (QLQ) C-30. This health related quality of life (HRQoL) questionnaire was comprised of 15 questions on functional scales, 13 questions on symptom scales and 2 on global health status scale. Global Health Status used a 7 point Likert-type scale of 1 (Very poor) to 7 (Excellent). All scores were transformed to 0-100. Higher scores for Global Health Status indicated better HRQoL.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Quality of Life (QoL) Analysis Set with data available at given timepoint were analyzed. The QoL Analysis Set was defined as the subset of participants in the Full Analysis Set who have a baseline and Day 150 post-randomization QoL assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EORTC QLQ-C30 Physical Functioning Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axicabtagene Ciloleucel', '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': 'OG001', 'title': 'Standard of Care Therapy', '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.'}], 'classes': [{'title': 'Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.5', 'spread': '17.7', 'groupId': 'OG000'}, {'value': '85.3', 'spread': '18.9', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Day 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-12.9', 'spread': '21.7', 'groupId': 'OG000'}, {'value': '-8.3', 'spread': '17.5', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Day 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '17.8', 'groupId': 'OG000'}, {'value': '-15.0', 'spread': '19.1', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Day 150', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '18.9', 'groupId': 'OG000'}, {'value': '-5.2', 'spread': '21.3', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.1', 'spread': '17.1', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '23.5', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '20.8', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '20.3', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '19.3', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '16.1', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.0', 'spread': '15.1', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '17.9', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.0', 'spread': '16.1', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '21.4', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '16.5', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '8.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mixed Model with Repeated Measures', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.1', 'ciLowerLimit': '8.0', 'ciUpperLimit': '18.2', 'pValueComment': 'False Discovery Rate Methodology.', 'groupDescription': 'Difference in mean change of scores from Baseline at Day 100.', 'statisticalMethod': 'Mixed Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1253', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mixed Model with Repeated Measures', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.1', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '11.0', 'pValueComment': 'False Discovery Rate Methodology.', 'groupDescription': 'Difference in mean change of scores from Baseline at Day 150.', 'statisticalMethod': 'Mixed Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 50, 100, 150, Months 9, 12, 15, 18, 21 and 24', 'description': 'The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).\n\nThe Physical Functioning domain includes 5 questions in which participants were asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 7 (excellent). The 5 scores were transformed to a scale from 0 to 100, where a high score indicated better QoL. A positive change from baseline indicates better QoL.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in QoL analysis set with data available at given timepoint were analyzed.'}, {'type': 'SECONDARY', 'title': 'Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Scale Index Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axicabtagene Ciloleucel', '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': 'OG001', 'title': 'Standard of Care Therapy', '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.'}], 'classes': [{'title': 'Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.803', 'spread': '0.210', 'groupId': 'OG000'}, {'value': '0.799', 'spread': '0.250', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Day 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.049', 'spread': '0.205', 'groupId': 'OG000'}, {'value': '-0.003', 'spread': '0.198', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Day 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.012', 'spread': '0.191', 'groupId': 'OG000'}, {'value': '-0.068', 'spread': '0.246', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Day 150', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.050', 'spread': '0.212', 'groupId': 'OG000'}, {'value': '0.014', 'spread': '0.208', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.064', 'spread': '0.190', 'groupId': 'OG000'}, {'value': '0.015', 'spread': '0.197', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.072', 'spread': '0.241', 'groupId': 'OG000'}, {'value': '0.051', 'spread': '0.200', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.051', 'spread': '0.209', 'groupId': 'OG000'}, {'value': '0.080', 'spread': '0.125', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.094', 'spread': '0.180', 'groupId': 'OG000'}, {'value': '0.072', 'spread': '0.188', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.089', 'spread': '0.235', 'groupId': 'OG000'}, {'value': '0.110', 'spread': '0.177', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.051', 'spread': '0.239', 'groupId': 'OG000'}, {'value': '0.117', 'spread': '0.138', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0112', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mixed Model with Repeated Measures', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.081', 'ciLowerLimit': '0.024', 'ciUpperLimit': '0.138', 'pValueComment': 'False Discovery Rate Methodology.', 'groupDescription': 'Difference in mean change of scores from Baseline at Day 100.', 'statisticalMethod': 'Mixed Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3703', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mixed Model with Repeated Measures', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.028', 'ciLowerLimit': '-0.034', 'ciUpperLimit': '0.091', 'pValueComment': 'False Discovery Rate Methodology.', 'groupDescription': 'Difference in mean change of scores from Baseline at Day 150.', 'statisticalMethod': 'Mixed Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 50, 100, 150; Months 9, 12, 15, 18, 21 and 24', 'description': 'The Euro-QOL (EQ) Five Dimensions (5D) Five Levels (5L), EQ-5D-5L questionnaire was a generic measure of health status that provided a simple descriptive profile and a single index value. The EQ-5D-5L comprised 2 components: a questionnaire covering 5 dimensions and a tariff of values based upon direct valuations of health stated using a visual analog scale (VAS). The total score for EQ-5D-5L index was presented on a range from 0 to 1 where higher scores indicated better outcome. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in QoL analysis set with data available at given timepoint were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EQ-5D-5L VAS Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axicabtagene Ciloleucel', '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': 'OG001', 'title': 'Standard of Care Therapy', '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.'}], 'classes': [{'title': 'Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.4', 'spread': '18.7', 'groupId': 'OG000'}, {'value': '74.4', 'spread': '20.1', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Day 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '18.7', 'groupId': 'OG000'}, {'value': '-4.4', 'spread': '16.7', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Day 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '18.4', 'groupId': 'OG000'}, {'value': '-8.2', 'spread': '19.8', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Day 150', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.1', 'spread': '19.4', 'groupId': 'OG000'}, {'value': '-2.2', 'spread': '22.2', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.4', 'spread': '19.9', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '19.0', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.1', 'spread': '19.9', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '17.8', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.7', 'spread': '20.7', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '13.7', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.1', 'spread': '17.1', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '13.6', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.0', 'spread': '17.2', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '14.3', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Study Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.9', 'spread': '18.8', 'groupId': 'OG000'}, {'value': '12.2', 'spread': '15.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mixed Model with Repeated Measures', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.7', 'ciLowerLimit': '8.5', 'ciUpperLimit': '18.8', 'pValueComment': 'False Discovery Rate Methodology', 'groupDescription': 'Difference in mean change of scores from Baseline at Day 100.', 'statisticalMethod': 'Mixed Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed Model with Repeated Measures Differences in Change from Baseline.'}, {'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mixed Model with Repeated Measures', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.3', 'ciLowerLimit': '5.4', 'ciUpperLimit': '17.1', 'pValueComment': 'False Discovery Rate Methodology', 'groupDescription': 'Difference in mean change of scores from Baseline at Day 150.', 'statisticalMethod': 'Mixed Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2549', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mixed Model with Repeated Measures', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.8', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '10.0', 'pValueComment': 'False Discovery Rate Methodology.', 'groupDescription': 'Difference in mean change of scores from Baseline at Month 9.', 'statisticalMethod': 'Mixed Model with Repeated Measures', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Mixed Model with Repeated Measures Differences in Change from Baseline.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 50, 100, 150; Months 9, 12, 15, 18, 21 and 24', 'description': 'The EQ-5D-5L VAS is a 20-cm VAS for recording self-rated current HRQoL state and is used to describe the participants\' health status on the day of the assessment. The EQ-5D-5L VAS score is recorded by each participant for his or her current HRQoL state and scored 0 ("the worst health you can imagine") to 100 ("the best health you can imagine"). The value 100 indicates improvement.', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in QoL analysis set with data available at given timepoint were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Post-dose Anti-Axicabtagene Ciloleucel Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Axicabtagene Ciloleucel', '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 74.9 months', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set were analyzed. The Safety Analysis Set was defined as the subset of all randomized participants who received at least 1 dose of axicabtagene ciloleucel as protocol therapy or SOC chemotherapy as protocol therapy.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axicabtagene Ciloleucel', '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-CD 19 CAR transduced autologous T cells/kg on Day 0.'}, {'id': 'OG001', 'title': 'Standard of Care Therapy', '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 infusion on Day 2 + mesna, carboplatin area under the curve (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 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 infusion 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose up to 61.8 months', 'description': 'A TEAE was defined as any AE that begins on or after the first dose of study treatment (axicabtagene ciloleucel infusion or SOC), excluding bridging therapy.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axicabtagene Ciloleucel', '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': 'OG001', 'title': 'Standard of Care Therapy', '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.'}], 'classes': [{'title': 'Hemoglobin (mmol/L)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes (10^9/L)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes (10^9/L)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase (U/L)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Alkaline Phosphatase (U/L)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase (U/L)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin (umol/L)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Calcium (mmol/L)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine (umol/L)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Glucose (mmol/L)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Magnesium (mmol/L)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Potassium (mmol/L)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Sodium (mmol/L)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose up to 61.8 months', 'description': 'Grading categories were determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening. Percentages were rounded off.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set with available data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axicabtagene Ciloleucel', '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': 'OG001', 'title': 'Standard of Care Therapy', '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.'}], 'classes': [{'title': 'Hemoglobin (mmol/L)', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes (10^9/L)', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes (10^9/L)', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils (10^9/L)', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Platelets (10^9/L)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'Albumin (g/L)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Calcium (mmol/L)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Glucose (mmol/L)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Magnesium (mmol/L)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Phosphate (mmol/L)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Potassium (mmol/L)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Sodium (mmol/L)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose up to 61.8 months', 'description': 'Grading categories were determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening. Percentages were rounded off.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in the Safety Analysis Set were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Axicabtagene Ciloleucel', 'description': 'Participants received cyclophosphamide 500 mg/m\\^2/day intravenous (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-cluster of differentiation antigen (CD) 19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0.'}, {'id': 'FG001', 'title': 'Standard of Care Therapy', 'description': 'Participants received 2 or 3, 21-day cycles of second-line chemotherapy regimen:\n\nR-ICE: rituximab 375mg/m\\^2 before chemotherapy, ifosfamide 5g/m\\^2 24 hours continuous infusion (CI) on Day 2 + mesna, carboplatin area under the curve (AUC) 5 Day 2, maximum dose 800mg, etoposide 100mg/m\\^2/day on Days 1-3; 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; 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 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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '180'}, {'groupId': 'FG001', 'numSubjects': '179'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '178'}, {'groupId': 'FG001', 'numSubjects': '112'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '91'}]}, {'type': 'Rollover to Long-term Follow-up Study Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Subject Withdrawal of Consent from Further Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Investigator Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study sites in North America, Middle East, Europe, and Australia.', 'preAssignmentDetails': '437 participants were screened.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '359', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Axicabtagene Ciloleucel', '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-CD 19 CAR transduced autologous T cells/kg on Day 0.'}, {'id': 'BG001', 'title': 'Standard of Care Therapy', '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': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.1', 'spread': '12.0', 'groupId': 'BG000'}, {'value': '57.4', 'spread': '12.2', 'groupId': 'BG001'}, {'value': '57.2', 'spread': '12.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '122', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '167', 'groupId': 'BG000'}, {'value': '169', 'groupId': 'BG001'}, {'value': '336', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '297', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Full Analysis Set (FAS) consisted of all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-14', 'size': 3426936, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-09-26T12:26', 'hasProtocol': True}, {'date': '2020-06-22', 'size': 1175840, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-11-21T07:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 359}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-11', 'studyFirstSubmitDate': '2017-12-21', 'resultsFirstSubmitDate': '2023-12-20', 'studyFirstSubmitQcDate': '2017-12-29', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2024-02-09', 'studyFirstPostDateStruct': {'date': '2018-01-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Event Free Survival (EFS) Per Blinded Central Assessment', 'timeFrame': 'From randomization date up to a median follow-up: 24.9 months', 'description': 'EFS:Time from randomization to disease progression (PD), best response of stable disease (SD) up to Day 150, start of new anti-lymphoma therapy including stem cell transplant, or death from any cause. PD=Score 4 (uptake moderately \\> liver) or 5 (uptake markedly \\> liver and/or new lesions) with increased uptake from baseline; New fluorodeoxyglucose (FDG)-avid foci consistent with lymphoma rather than another etiology or in bone marrow; Individual node/lesion abnormal with longest diameter \\> 1.5 cm, ≥ 50% increase from nadir; Splenic length increase \\> 50% of prior increase beyond baseline or ≥ 2 cm increase if no prior splenomegaly; New/recurrent splenomegaly, progression of non-measurable lesions, new lesion, or new/recurrent bone marrow involvement. KM estimates was used for analysis.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR) Per Blinded Central Assessment', 'timeFrame': 'From randomization date up to a median follow-up: 24.9 months', 'description': 'ORR: Percentage of participants with CR (Complete Metabolic Response (CMR);Complete Radiologic Response (CRR)) or PR (partial metabolic response (PMR); partial radiologic response (PRR)).CMR: Positron emission tomography (PET) 5-point scale scores: 1-No uptake above background; 2-Uptake ≤mediastinum; 3-Uptake \\>mediastinum but ≤liver, with/without residual mass; no new lesions, no FDG-avid disease in bone marrow. CRR: Target nodes/nodal masses regressed ≤1.5 cm in longest diameter, no extralymphatic sites, no non-measured lesions, normal organ size, no new sites, normal bone marrow morphology. PMR: Scores 4 (uptake moderately \\>liver), 5 (uptake markedly \\>liver, new lesions) with reduced uptake from baseline and residual mass, no new lesions. Responding at interim/residual disease at end of treatment. PRR: ≥50% decrease in sum of diameters of up to 6 target measurable lesions, no increase in non-measured lesions, spleen length decreased \\>50% if previously enlarged, no new lesion sites.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 74.9 months', 'description': 'Overall survival is defined as the time from randomization to death from any cause. Kaplan-Meier (KM) estimates were used for analysis.'}, {'measure': 'Duration of Response (DOR) Per Blinded Central Assessments', 'timeFrame': 'From the date of first confirmed objective response (CR or PR) to disease progression or death regardless of cause (Up to 37.8 months)', 'description': 'DOR was defined only for participants who experience an objective response after axicabtagene ciloleucel infusion and was the time from the first objective response per Lugano classification to disease progression or death from any cause. Objective response was defined in outcome measure 2 and disease progression was defined in outcome measure 1. KM estimates were used for analysis.'}, {'measure': 'Modified Event Free Survival (mEFS) Per Blinded Central Assessment', 'timeFrame': 'From randomization date up to a median follow-up: 24.9 months', 'description': 'Modified event free survival is defined the same way as EFS, except that a best response of SD up to and including Day 150 assessment post randomization was not considered an event. KM estimates were used for analysis.'}, {'measure': 'EFS Per Investigator Disease Assessments', 'timeFrame': 'From randomization date up to a median follow-up: 47.2 months', 'description': 'EFS was defined as the time from randomization to the earliest date of disease progression per the Lugano Classification, best response of stable disease (SD) up to and including Day 150, commencement of new lymphoma therapy, or death from any cause. Disease progression is defined in outcome measure 1.'}, {'measure': 'Progression-Free Survival (PFS) Per Investigator Disease Assessments', 'timeFrame': 'From randomization date up to a median follow-up: 47.2 months', 'description': 'PFS is defined as the time from the randomization date to the date of disease progression per Lugano classification or death from any cause. Disease progression is defined in outcome measure 1. KM estimates were used for analysis.'}, {'measure': 'Modified Event Free Survival (mEFS) Per Investigator Assessment', 'timeFrame': 'From randomization date up to a median follow-up: 47.2 months', 'description': 'mEFS is defined the same way as EFS, except that a best response of SD up to and including Day 150 assessment post randomization was not considered an event. KM estimates were used for analysis.'}, {'measure': 'Change From Baseline in Global Health Status Scores', 'timeFrame': 'Baseline, Days 50, 100, and 150; Months 9, 12, 15, 18, 21 and 24', 'description': 'Global health status was measured using European Organization for Research and Treatment of Cancer (EORTC) Quality Life Questionnaire (QLQ) C-30. This health related quality of life (HRQoL) questionnaire was comprised of 15 questions on functional scales, 13 questions on symptom scales and 2 on global health status scale. Global Health Status used a 7 point Likert-type scale of 1 (Very poor) to 7 (Excellent). All scores were transformed to 0-100. Higher scores for Global Health Status indicated better HRQoL.'}, {'measure': 'Change From Baseline in EORTC QLQ-C30 Physical Functioning Score', 'timeFrame': 'Baseline, Days 50, 100, 150, Months 9, 12, 15, 18, 21 and 24', 'description': 'The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).\n\nThe Physical Functioning domain includes 5 questions in which participants were asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 7 (excellent). The 5 scores were transformed to a scale from 0 to 100, where a high score indicated better QoL. A positive change from baseline indicates better QoL.'}, {'measure': 'Changes From Baseline in the European Quality of Life Five Dimensions Five Levels Scale Index Score', 'timeFrame': 'Baseline, Days 50, 100, 150; Months 9, 12, 15, 18, 21 and 24', 'description': 'The Euro-QOL (EQ) Five Dimensions (5D) Five Levels (5L), EQ-5D-5L questionnaire was a generic measure of health status that provided a simple descriptive profile and a single index value. The EQ-5D-5L comprised 2 components: a questionnaire covering 5 dimensions and a tariff of values based upon direct valuations of health stated using a visual analog scale (VAS). The total score for EQ-5D-5L index was presented on a range from 0 to 1 where higher scores indicated better outcome. A positive change from Baseline indicates improvement.'}, {'measure': 'Change From Baseline in EQ-5D-5L VAS Scale Score', 'timeFrame': 'Baseline, Days 50, 100, 150; Months 9, 12, 15, 18, 21 and 24', 'description': 'The EQ-5D-5L VAS is a 20-cm VAS for recording self-rated current HRQoL state and is used to describe the participants\' health status on the day of the assessment. The EQ-5D-5L VAS score is recorded by each participant for his or her current HRQoL state and scored 0 ("the worst health you can imagine") to 100 ("the best health you can imagine"). The value 100 indicates improvement.'}, {'measure': 'Number of Participants With Post-dose Anti-Axicabtagene Ciloleucel Antibodies', 'timeFrame': 'Up to 74.9 months'}, {'measure': 'Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'From first dose up to 61.8 months', 'description': 'A TEAE was defined as any AE that begins on or after the first dose of study treatment (axicabtagene ciloleucel infusion or SOC), excluding bridging therapy.'}, {'measure': 'Percentage of Participants With Increase in Laboratory Values Reported as Grade 3 or Higher', 'timeFrame': 'From first dose up to 61.8 months', 'description': 'Grading categories were determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening. Percentages were rounded off.'}, {'measure': 'Percentage of Participants With Decrease in Laboratory Values Reported as Grade 3 or Higher', 'timeFrame': 'From first dose up to 61.8 months', 'description': 'Grading categories were determined by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1: mild, Grade 2: moderate, Grade 3: severe or medically significant, Grade 4: life-threatening. Percentages were rounded off.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)']}, 'referencesModule': {'references': [{'pmid': '25113753', 'type': 'BACKGROUND', 'citation': "Cheson BD, Fisher RI, Barrington SF, Cavalli F, Schwartz LH, Zucca E, Lister TA; Alliance, Australasian Leukaemia and Lymphoma Group; Eastern Cooperative Oncology Group; European Mantle Cell Lymphoma Consortium; Italian Lymphoma Foundation; European Organisation for Research; Treatment of Cancer/Dutch Hemato-Oncology Group; Grupo Espanol de Medula Osea; German High-Grade Lymphoma Study Group; German Hodgkin's Study Group; Japanese Lymphorra Study Group; Lymphoma Study Association; NCIC Clinical Trials Group; Nordic Lymphoma Study Group; Southwest Oncology Group; United Kingdom National Cancer Research Institute. Recommendations for initial evaluation, staging, and response assessment of Hodgkin and non-Hodgkin lymphoma: the Lugano classification. J Clin Oncol. 2014 Sep 20;32(27):3059-68. doi: 10.1200/JCO.2013.54.8800."}, {'pmid': '26980727', 'type': 'BACKGROUND', 'citation': 'Swerdlow SH, Campo E, Pileri SA, Harris NL, Stein H, Siebert R, Advani R, Ghielmini M, Salles GA, Zelenetz AD, Jaffe ES. The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood. 2016 May 19;127(20):2375-90. doi: 10.1182/blood-2016-01-643569. Epub 2016 Mar 15.'}, {'pmid': '35839452', 'type': 'BACKGROUND', 'citation': 'Elsawy M, Chavez JC, Avivi I, Larouche JF, Wannesson L, Cwynarski K, Osman K, Davison K, Rudzki JD, Dahiya S, Dorritie K, Jaglowski S, Radford J, Morschhauser F, Cunningham D, Martin Garcia-Sancho A, Tzachanis D, Ulrickson ML, Karmali R, Kekre N, Thieblemont C, Enblad G, Dreger P, Malladi R, Joshi N, Wang WJ, Solem CT, Snider JT, Cheng P, To C, Kersten MJ. Patient-reported outcomes in ZUMA-7, a phase 3 study of axicabtagene ciloleucel in second-line large B-cell lymphoma. Blood. 2022 Nov 24;140(21):2248-2260. doi: 10.1182/blood.2022015478.'}, {'pmid': '36646322', 'type': 'BACKGROUND', 'citation': 'Kersten MJ, Qiao Y, Shah R, Solem C, Snider JT, To C, Cheng P, Spooner C, Perales MA. Quality-Adjusted Time without Symptoms or Toxicity: Analysis of Axicabtagene Ciloleucel versus Standard of Care in Patients with Relapsed/Refractory Large B Cell Lymphoma. Transplant Cell Ther. 2023 May;29(5):335.e1-335.e8. doi: 10.1016/j.jtct.2023.01.008. Epub 2023 Jan 14.'}, {'pmid': '34891224', 'type': 'BACKGROUND', 'citation': 'Locke FL, Miklos DB, Jacobson CA, Perales MA, Kersten MJ, Oluwole OO, Ghobadi A, Rapoport AP, McGuirk J, Pagel JM, Munoz J, Farooq U, van Meerten T, Reagan PM, Sureda A, Flinn IW, Vandenberghe P, Song KW, Dickinson M, Minnema MC, Riedell PA, Leslie LA, Chaganti S, Yang Y, Filosto S, Shah J, Schupp M, To C, Cheng P, Gordon LI, Westin JR; All ZUMA-7 Investigators and Contributing Kite Members. Axicabtagene Ciloleucel as Second-Line Therapy for Large B-Cell Lymphoma. N Engl J Med. 2022 Feb 17;386(7):640-654. doi: 10.1056/NEJMoa2116133. Epub 2021 Dec 11.'}, {'pmid': '36999993', 'type': 'BACKGROUND', 'citation': 'Westin JR, Locke FL, Dickinson M, Ghobadi A, Elsawy M, van Meerten T, Miklos DB, Ulrickson ML, Perales MA, Farooq U, Wannesson L, Leslie L, Kersten MJ, Jacobson CA, Pagel JM, Wulf G, Johnston P, Rapoport AP, Du L, Vardhanabhuti S, Filosto S, Shah J, Snider JT, Cheng P, To C, Oluwole OO, Sureda A. Safety and Efficacy of Axicabtagene Ciloleucel versus Standard of Care in Patients 65 Years of Age or Older with Relapsed/Refractory Large B-Cell Lymphoma. Clin Cancer Res. 2023 May 15;29(10):1894-1905. doi: 10.1158/1078-0432.CCR-22-3136.'}, {'pmid': '37272527', 'type': 'BACKGROUND', 'citation': 'Westin JR, Oluwole OO, Kersten MJ, Miklos DB, Perales MA, Ghobadi A, Rapoport AP, Sureda A, Jacobson CA, Farooq U, van Meerten T, Ulrickson M, Elsawy M, Leslie LA, Chaganti S, Dickinson M, Dorritie K, Reagan PM, McGuirk J, Song KW, Riedell PA, Minnema MC, Yang Y, Vardhanabhuti S, Filosto S, Cheng P, Shahani SA, Schupp M, To C, Locke FL; ZUMA-7 Investigators; Kite Members. Survival with Axicabtagene Ciloleucel in Large B-Cell Lymphoma. N Engl J Med. 2023 Jul 13;389(2):148-157. doi: 10.1056/NEJMoa2301665. Epub 2023 Jun 5.'}, {'type': 'BACKGROUND', 'citation': 'Filosto S, Vardhanabhuti S, Canales M, Poiré X, Lekakis LJ, de Vos S, et al. Product attributes of axicabtagene ciloleucel (axi-cel) that associate differentially with efficacy and toxicity in second-line large B-cell lymphoma. Cancer Res. 2022;82(12_Supplement):CT004.'}, {'type': 'BACKGROUND', 'citation': 'Ghobadi A, Munoz J, Westin J, Locke FL, Miklos DB, Rapoport AP, et al. Outcomes of Subsequent Anti-Lymphoma Therapies in Patients (Pts) with Large B-Cell Lymphoma (LBCL) Treated with Axicabtagene Ciloleucel (Axi-Cel) or Standard of Care (SOC) in the Second-Line (2L) ZUMA-7 Study. Blood. 2022;140(Supplement 1):1595-1597.'}, {'type': 'BACKGROUND', 'citation': 'Locke FL, Oluwole OO, Kuruvilla J, Thieblemont C, Morschhauser F, Salles G, et al. Association of Metabolic Tumor Volume (MTV) and Clinical Outcomes in Second-Line (2L) Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL) Following Axicabtagene Ciloleucel (Axi-Cel) Versus Standard-of-Care (SOC) Therapy in ZUMA-7. Blood. 2022;140(Supplement 1):638-640.'}, {'pmid': '39240498', 'type': 'BACKGROUND', 'citation': "Chartier M, Filosto S, Peyret T, Chiney M, Milletti F, Budka J, Ndi A, Dong J, Vardhanabhuti S, Mao D, Duffull S, Dodds M, Shen R. Investigating the Influence of Covariates on Axicabtagene Ciloleucel (axi-cel) Kinetics in Patients with Non-Hodgkin's Lymphoma. Clin Pharmacokinet. 2024 Sep;63(9):1283-1299. doi: 10.1007/s40262-024-01413-z. Epub 2024 Sep 6."}, {'pmid': '37983485', 'type': 'BACKGROUND', 'citation': 'Filosto S, Vardhanabhuti S, Canales MA, Poire X, Lekakis LJ, de Vos S, Portell CA, Wang Z, To C, Schupp M, Poddar S, Trinh T, Warren CM, Aguilar EG, Budka J, Cheng P, Chou J, Bot A, Shen RR, Westin JR. Product Attributes of CAR T-cell Therapy Differentially Associate with Efficacy and Toxicity in Second-line Large B-cell Lymphoma (ZUMA-7). Blood Cancer Discov. 2024 Jan 8;5(1):21-33. doi: 10.1158/2643-3230.BCD-23-0112.'}, {'pmid': '38315832', 'type': 'BACKGROUND', 'citation': 'Ghobadi A, Munoz J, Westin JR, Locke FL, Miklos DB, Rapoport AP, Perales MA, Reagan PM, McGuirk J, Jacobson CA, Kersten MJ, Avivi I, Peng A, Schupp M, To C, Oluwole OO. Outcomes of subsequent antilymphoma therapies after second-line axicabtagene ciloleucel or standard of care in ZUMA-7. Blood Adv. 2024 Jun 11;8(11):2982-2990. doi: 10.1182/bloodadvances.2023011532.'}, {'type': 'BACKGROUND', 'citation': 'Locke FL, Chou J, Vardhanabhuti S, Perbost R, Dreger P, Hill BT, et al. Association of pretreatment (preTx) tumor characteristics and clinical outcomes following second-line (2L) axicabtagene ciloleucel (axi-cel) versus standard of care (SOC) in patients (pts) with relapsed/refractory (R/R) large B-cell lymphoma (LBCL). J Clin Oncol.2022;40(16_suppl):7565'}, {'pmid': '38233586', 'type': 'BACKGROUND', 'citation': 'Locke FL, Filosto S, Chou J, Vardhanabhuti S, Perbost R, Dreger P, Hill BT, Lee C, Zinzani PL, Kroger N, Lopez-Guillermo A, Greinix H, Zhang W, Tiwari G, Budka J, Marincola FM, To C, Mattie M, Schupp M, Cheng P, Bot A, Shen R, Bedognetti D, Miao H, Galon J. Impact of tumor microenvironment on efficacy of anti-CD19 CAR T cell therapy or chemotherapy and transplant in large B cell lymphoma. Nat Med. 2024 Feb;30(2):507-518. doi: 10.1038/s41591-023-02754-1. Epub 2024 Jan 17.'}, {'pmid': '38557775', 'type': 'BACKGROUND', 'citation': 'Locke FL, Oluwole OO, Kuruvilla J, Thieblemont C, Morschhauser F, Salles G, Rowe SP, Vardhanabhuti S, Winters J, Filosto S, To C, Cheng P, Schupp M, Korn R, Kersten MJ. Axicabtagene ciloleucel vs standard of care in second-line large B-cell lymphoma: outcomes by metabolic tumor volume. Blood. 2024 Jun 13;143(24):2464-2473. doi: 10.1182/blood.2023021620.'}, {'pmid': '38504387', 'type': 'BACKGROUND', 'citation': 'Lunning MA, Wang HL, Hu ZH, Locke FL, Siddiqi T, Jacobson CA, Ahmed S, Miklos DB, Lin Y, Hill BT, Ghobadi A, Neelapu SS, Westin J, Dieyi C, Field P, Miao H, Shahani SA, Patel A, Spooner C, Fu C, Muramoto D, Xu H, Pasquini MC. Benefit of axicabtagene ciloleucel versus chemoimmunotherapy in older patients and/or patients with poor ECOG performance status with relapsed or refractory large B-cell lymphoma after 2 or more lines of prior therapy. Am J Hematol. 2024 May;99(5):880-889. doi: 10.1002/ajh.27283. Epub 2024 Mar 19.'}, {'pmid': '40083872', 'type': 'BACKGROUND', 'citation': 'Tian Y, Budka J, Locke FL, Westin JR, To C, Tiwari G, Mao D, Bedognetti D, Shen RR, Andrade J, Filosto S. Tumor gene expression signatures associated with outcome in large B-cell lymphoma treated with CD19-directed CAR T-cell therapy (axicabtagene ciloleucel). Front Oncol. 2025 Feb 27;15:1519473. doi: 10.3389/fonc.2025.1519473. eCollection 2025.'}, {'pmid': '38635762', 'type': 'DERIVED', 'citation': 'Locke FL, Siddiqi T, Jacobson CA, Ghobadi A, Ahmed S, Miklos DB, Perales MA, Munoz J, Fingrut WB, Pennisi M, Gauthier J, Shadman M, Gowda L, Mirza AS, Abid MB, Hong S, Majhail NS, Kharfan-Dabaja MA, Khurana A, Badar T, Lin Y, Bennani NN, Herr MM, Hu ZH, Wang HL, Baer A, Baro E, Miao H, Spooner C, Xu H, Pasquini MC. Real-world and clinical trial outcomes in large B-cell lymphoma with axicabtagene ciloleucel across race and ethnicity. Blood. 2024 Jun 27;143(26):2722-2734. doi: 10.1182/blood.2023023447.'}, {'pmid': '35114155', 'type': 'DERIVED', 'citation': 'The Lancet Haematology. The role of conferences in tackling inequalities. Lancet Haematol. 2022 Feb;9(2):e81. doi: 10.1016/S2352-3026(22)00008-4. No abstract available.'}, {'pmid': '34922648', 'type': 'DERIVED', 'citation': 'Del Pozo Martin Y. 2021 ASH annual meeting. Lancet Haematol. 2022 Feb;9(2):e92-e93. doi: 10.1016/S2352-3026(21)00384-7. Epub 2021 Dec 16. No abstract available.'}, {'pmid': '34515338', 'type': 'DERIVED', 'citation': 'Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.'}, {'pmid': '33288485', 'type': 'DERIVED', 'citation': 'Thiruvengadam SK, Hunter B, Varnavski A, Fakhri B, Kaplan L, Ai WZ, Pampaloni M, Huang CY, Martin T 3rd, Damon L, Andreadis CB. Ofatumumab, Etoposide, and Cytarabine Intensive Mobilization Regimen in Patients with High-risk Relapsed/Refractory Diffuse Large B-Cell Lymphoma Undergoing Autologous Stem Cell Transplantation. Clin Lymphoma Myeloma Leuk. 2021 Apr;21(4):246-256.e2. doi: 10.1016/j.clml.2020.11.005. Epub 2020 Nov 11.'}], 'seeAlsoLinks': [{'url': 'https://www.gileadclinicaltrials.com/study/?id=KTE-C19-107', 'label': 'Gilead Clinical Trials Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical study is to assess whether axicabtagene ciloleucel therapy improves the clinical outcome compared with standard of care second-line therapy in participants with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).', 'detailedDescription': 'After completing the treatment period, all participants will be followed in the post-treatment follow-up period for up to 5 years. Thereafter, participants who received at least one dose of axicabtagene ciloleucel as protocol therapy will transition to a separate long term follow up (LTFU) study and complete the remainder of the 15-year follow-up assessments within KT-US-982-5968 (NCT05041309).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Histologically proven large B-cell lymphoma (BCL) including the following types defined by World Health Organization (WHO) 2016.\n\n * Diffuse large B-cell lymphoma (DLBCL) not otherwise specified activated B-cell/ germinal center B-cell (ABC/GCB).\n * High-grade B-cell lymphoma (HGBL) with or without myelocytomatosis oncogene (MYC) and BCL 2 and/or BCL 6 rearrangement.\n * DLBCL arising from follicular lymphoma (FL).\n * T-cell/histiocyte rich large B-cell lymphoma.\n * DLBCL associated with chronic inflammation.\n * Primary cutaneous DLBCL, leg type.\n * Epstein-Barr virus (EBV) + DLBCL.\n* Relapsed or refractory disease after first-line chemoimmunotherapy.\n\n * Refractory disease defined as no complete remission to first-line therapy; individuals who are intolerant to first-line therapy are excluded.\n\n * Progressive disease (PD) as best response to first-line therapy.\n * Stable disease (SD) as best response after at least 4 cycles of first-line therapy (eg, 4 cycles of R-CHOP).\n * Partial response (PR) as best response after at least 6 cycles and biopsy-proven residual disease or disease progression ≤ 12 months of therapy.\n * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven relapse ≤ 12 months of first-line therapy.\n* Individuals must have received adequate first-line therapy including at a minimum:\n\n * Anti-Cluster of Differentiation 20 antigen (CD20) monoclonal antibody unless investigator determines that tumor is CD20 negative, and\n * An anthracycline containing chemotherapy regimen.\n* No known history or suspicion of central nervous system involvement by lymphoma.\n* Eastern cooperative oncology group (ECOG) performance status of 0 or 1.\n* Adequate bone marrow function as evidenced by:\n\n * Absolute neutrophil count (ANC) ≥ 1000/μl\n * Platelet ≥ 75,000/μl\n * Absolute lymphocyte count ≥ 100/μl\n* Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by:\n\n * Creatinine clearance (Cockcroft Gault) ≥ 60 mL/min.\n * Serum Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) ≤ 2.5 Upper limit of normal (ULN).\n * Total bilirubin ≤ 1.5 mg/dl\n * Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an Echocardiogram (ECHO), and no clinically significant Electrocardiogram (ECG) findings.\n * No clinically significant pleural effusion.\n * Baseline oxygen saturation \\> 92% on room air.\n\nKey Exclusion Criteria:\n\n* History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg cervix, bladder, breast) unless disease free for at least 3 years.\n* Received more than one line of therapy for DLBCL.\n* History of autologous or allogeneic stem cell transplant.\n* Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management.\n* Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or anti-hepatitis C virus (HCV) positive. If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n* Individuals with detectable cerebrospinal fluid malignant cells or known brain metastases, or with a history of cerebrospinal fluid malignant cells or brain metastases.\n* History or presence of non-malignant central nervous system (CNS) disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.\n* Presence of any indwelling line or drain. Dedicated central venous access catheter such as a Port-a-Cath or Hickman catheter are permitted.\n* History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac diseases within 12 months of enrollment.\n* History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment.\n* History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years.\n* History of anti-Cluster of Differentiation 19 (CD19) or chimeric antigen receptor (CAR)-T therapy or history of prior randomization in ZUMA-7.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT03391466', 'acronym': 'ZUMA-7', 'briefTitle': 'Study of Effectiveness of Axicabtagene Ciloleucel Compared to Standard of Care Therapy in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7)', 'orgStudyIdInfo': {'id': 'KTE-C19-107'}, 'secondaryIdInfos': [{'id': '2017-002261-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Axicabtagene Ciloleucel Treatment', 'description': 'Participants will receive cyclophosphamide 500 mg/m\\^2/day intravenously (IV) and fludarabine 30 mg/m\\^2/day IV 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-cluster of differentiation antigen (CD) 19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0.\n\nParticipants who will achieve a partial response or complete response and subsequently experience disease progression may have an option to receive a second course of conditioning chemotherapy and axicabtagene ciloleucel.', 'interventionNames': ['Biological: Axicabtagene Ciloleucel', 'Drug: Cyclophosphamide', 'Drug: Fludarabine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care Therapy', 'description': 'Participants will receive 2 or 3, 21-day cycles of second-line chemotherapy:\n\n* R-ICE:rituximab 375mg/m\\^2 before chemotherapy, ifosfamide 5g/m\\^2 24 hours continuous infusion (CI) on Day 2+mesna, carboplatin area under the curve (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 area under the curve (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\nResponders will receive high-dose therapy and autologous stem cell transplant.', 'interventionNames': ['Drug: Platinum-containing Salvage Chemotherapy']}], 'interventions': [{'name': 'Axicabtagene Ciloleucel', 'type': 'BIOLOGICAL', 'otherNames': ['KTE-C19', 'axi-cel', 'Yescarta ®'], 'description': 'Administered intravenously', 'armGroupLabels': ['Axicabtagene Ciloleucel Treatment']}, {'name': 'Platinum-containing Salvage Chemotherapy', 'type': 'DRUG', 'description': 'Platinum-containing salvage chemotherapy (Rituximab-ifosfamide, carboplatin, etoposide (R-ICE), Rituximab-dexamethasone, cytarabine, cisplatin,oxaliplatin (R-DHAP), Rituximab-etoposide, methylprednisolone, cisplatin, cytarabine (R-ESHAP), or Rituximab-gemcitabine, dexamethasone, cisplatin/carboplatin (R-GDP) as selected by treating investigator).', 'armGroupLabels': ['Standard of Care Therapy']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Administered intravenously', 'armGroupLabels': ['Axicabtagene Ciloleucel Treatment']}, {'name': 'Fludarabine', 'type': 'DRUG', 'description': 'Administered intravenously', 'armGroupLabels': ['Axicabtagene Ciloleucel Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner MD Anderson Cancer Center', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Hospital', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 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